705 ALBUMIN FS - Asterisco€¦ · 844 0220 705 ALBUMIN FS Order information Cat. No. Kit size...

844 0220 705

ALBUMIN FS Order information Cat. No. Kit size 10 022 021 R 5 x 25 ml + 1 x 3 ml standard 1 0220 99 10 026 R 6 x 100 ml 10 022 023 R 1 x 1000 ml 10 020 030 6 x 3 ml standard

10 022 705 R 5x 180 ml

Method Colorimetric test, “Bromocresol green“

Serum albumin in the presence of Bromcresol green at a slightly acid pH produces a color change of the indicator from yellow-green to green-blue.

Reagent preparation and stability

The reagent is ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided, stored at 2 – 25 °C and protected from light. Stability of standard: until expiry date, when stored at 2 – 8 °C

Specimen Serum, heparinized or EDTA plasma. Avoid hemolysis! Stability in serum: 1 month at 2 – 8 °C 1 week at 15 – 25 °C

Components and concentration in the test Citrate buffer pH 4.2 30 mmol/l Bromcresol Green 0.26 mmol/l Standard: 5 g/dl

Normal range (see reference 3)

Adults 3.5 - 5.0 g/dl

References

1. Doumas, B. T., Watson, W. A., Biggs, H. G., Clin. Chim. Acta., 31, (1971), 87 - 96

2. Webster, D., Clin. Chim. Acta, 53, (1974), 109 – 115 3. Tietz, N. W.: Textbook of Clinical Chemistry, 2

nd edition,

W. B. Saunders Company, Philadelphia 1994, 703 * fluid stable

HITACHI 705 Chemistry settings Temperature: 37°C PROGRAM 6: CHEMISTRY PARAMETERS

TEST 2 (ALB) ASSAY CODE 1 SAMPLE VOLUME (µl) 3 R1 VOLUME (µl) 350 - NO R2 VOLUME (µl) 1 - 1 - NO R3 VOLUME (µl) -------- WAVELENGTH 1 (nm) 700 WAVELENGTH 2 (nm) 600 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC.- # - # - # FACTOR * STD-ABS.ALLOWANCE (%) 10 NORMAL RANGE L (g/dl) 3.5 NORMAL RANGE H (g/dl) 5.0 ABS. LIMIT (RATE) 0 CONTROL ID.NO. # - # - #

PROGRAM 7: CHANNEL SETTING

CHANNEL NO. # TEST CODE 2

#) Data entry by the user *) Calculated by the analyzer

10.02.11

844 0411 705

ALKALINE PHOSPHATASE IFCC FS*

Order information Cat. No. Kit size 10 041 021 R1 5 x 20 ml + R2 1 x 25 ml 10 041 022 R1 5 x 80 ml + R2 1 x 100 ml 10 041 023 R1 1 x 800 ml + R2 1 x 200 ml

10 041 705 R1 4 x 160 ml + R2 8 x 20 ml

Method Kinetic, colorimetric test according to IFCC (International Federation of Clinical Chemistry)

In alkaline buffer AP convertes p-Nitrophenylphosphate into p-Nitrophenol and Phosphate. The increase in absorbance from p-Nitrophenol is directly proportional to the activity of the AP.

Reagent preparation and stability The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. The reagent 2 must be protected from light.

Specimen Serum, heparinized plasma. Avoid hemolysis! Loss of activity after 2 – 3 days at 15 – 25 °C < 10 %.

Components and concentration in the test R1: 2-Amino-2-methyl-1-propanol pH 10.4 0.35 mol/l Magnesium Sulphate 2.0 mmol/l Zinc Sulphate 1.0 mmol/l HEDTA 2.0 mmol/l R2: p-Nitrophenylphosphate 16.0 mmol/l

Notes 1. The reagents contain Sodium Azide (0.095 %) as preservative.

Do not swallow! Avoid contact with skin and mucous membranes.

2. During the reaction p-Nitrophenol is produced. This is poisonous when inhaled, swallowed or when absorbed throught the skin. If the reaction mixture comes into contact with skin or mucous membranes wash copiously with water!


37 °C Men (20 – 50 years) 53 – 128 U/l Men (> 60 years) 56 – 119 U/l Women (20 – 50 years) 42 – 98 U/l Women (> 60 years) 53 – 141 U/l

References

1. Tietz, N. W., Rinker, A. D., Shaw, L. M., J. Clin. Chem. Clin. Biochem., 21, (1983), 731 – 748

2. Tietz, N. W., Textbook of Clinical Chemistry, 2nd

edition, W. B. Saunders Company, Philadelphia 1994, 2202

* fluid stable


TEST 5 (ALP) ASSAY CODE (RATE) 2-19-31 SAMPLE VOLUME (µl) 5 R1 VOLUME (µl) 280-NO R2 VOLUME (µl) 70 # - YES R3 VOLUME (µl) ------- WAVELENGTH 1 (nm) 660 WAVELENGTH 2 (nm) 415 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC.- 0-0-0 FACTOR ** STD-ABS.ALLOWANCE (%) 0 NORMAL RANGE L (U/l) 42 NORMAL RANGE H (U/l) 141 ABS. LIMIT (RATE) 11000 CONTROL ID.NO. #-#-#



#) Data entry by the user *) Calculated by the analyzer **) The factor is approx. 6225 and must be checked by a calibratioon serum

10.02.11

844 0401 705

ALKALINE PHOSPHATASE DGKC FS*


10 040 705 R1 4 x 160 ml + R2 8 x 20 ml

Method Kinetic colorimetric test, optimized Standard Method according to DGKC (German Society of Clinical Chemistry).

In alkaline buffer AP convertes p-Nitrophenylphosphate into p-Nitrophenol and Phosphate. The increase in absorbance from p-Nitrophenol is directly proportional to the activity of the AP.


Specimen Serum, heparinized plasma. Avoid hemolysis! Loss of activity after 2 – 3 days at 15 – 25 °C < 10%.

Components and concentration in the test R1: Diethanolamine pH 9.8 1.0 mol/l

Magnesium Chloride 0.5 mmol/l

R2: p-Nitrophenylphosphate 10 mmol/l



2. During the reaction p-Nitrophenol is produced. This is poisonous when inhaled, swallowed or when absorbed throught the skin. If the reaction mixture comes into contact with skin or mucous membranes wash copiously with water!


37 °C Women 64 – 306 U/l Men 80 – 306 U/l

References

1. Empfehlungen der Deutschen Gesellschaft für Klinische Chemie, Z. Klin. Chem. u. Klin. Biochem., 8, (1970), 658

2. Empfehlungen der Deutschen Gesellschaft für Klinische Chemie, Z. Klin. Chem. u. Klin. Biochem., 10, (1972), 182

3. Weisshaar, D., Gossrau, E., Faderl, B., Med. Welt, 26, (1975), 387

4. Schlebusch, H., Rick, W., Lang, H., Knedel, M., Dtsch. Med. Wschr., 99, (1974), 765 - 766

* fluid stable

HITACHI 705

Chemistry settings Temperature: 37°C PROGRAM 6: CHEMISTRY PARAMETERS

TEST 5 (ALP) ASSAY CODE (RATE) 2-19-31 SAMPLE VOLUME (µl) 5 R1 VOLUME (µl) 280-NO R2 VOLUME (µl) 70-1-NO R3 VOLUME (µl) ------ WAVELENGTH 1 (nm) 660 WAVELENGTH 2 (nm) 415 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC.- 0-0-0 FACTOR ** STD-ABS.ALLOWANCE (%) 0 NORMAL RANGE L (U/l) 64 NORMAL RANGE H (U/l) 306 ABS. LIMIT (RATE) 11000 CONTROL ID.NO. #-#-#



#) Data entry by the user *) Calculated by the analyzer **) The factor is approx. 6225 and must be checked by a calibration

serum

10.02.11

844 0501 705

-AMYLASE CC* FS** Substrate EPS-G7 Order information Cat. No. Kit size 10 050 021 R1 5 x 20 ml + R2 1 x 25 ml 10 050 022 R1 5 x 80 ml + R2 1 x 100 ml 10 050 023 R1 1 x 800 ml + R2 1 x 200 ml

10 050 705 R1 4 x 160 ml + R2 8 x 20 ml

Method Enzymatic color test with complete conversion of all PNP- Oligomaltosides produced by Amylase activity. The test results represent Total Amylase activity (all isoenzymes).

Substrate: 4,6-Ethyliden-(G7)-p-Nitrophenyl (G1)-- D-Maltoheptaoside (EPS-G7)

Reagent preparation and stability The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided, stored at 2 – 8 °C and protected from light.

Specimen Serum, heparinized or EDTA plasma, urine. For serum / plasma: Avoid hemolysis! Stability: serum / plasma: min. 1 week at 2 – 25 °C urine: 2 days at 15 – 25 °C 10 days at 2 - 8 °C

Components and concentration in the test R1: GOOD’s buffer pH 7.1 100 mmol/l NaCl 50 mmol/l MgCl2 10 mmol/l Alpha-Glucosidase > 2 KU/l R2: GOOD’s buffer pH 7.1 100 mmol/l EPS-G7 1.6 mmol/l

Notes 1. For urine as sample material the sample volumes should be

divided in half. 2. Hemoglobin interferes.

3. Saliva and skin do contain -Amylase. Therefore never pipette by mouth and avoid skin contact with the reagents.

4. The reagents contain Sodium Azide (0.095 %) as preservative. Do not swallow! Avoid contact with skin and mucous membranes.

5. Conversion factor refers to previous PNP- G7 methods which utilised factors in order to correlate and keep the same normal range.


without conversion factor 37 °C

Serum / plasma up to 100 U/l Random urine up to 450 U/l 24 h urine up to 410 U/24 h with conversion factor 37 °C

Serum / plasma up to 220 U/l Random urine up to 1000 U/l 24 h urine up to 900 U/24 h

References

1. Hohenwallner, W., et al., J. Clin. Chem. Clin. Biochem., 27, (1989), 97 – 101

2. Kruse-Jarres, J. D., et al., J. Clin. Chem. Clin. Biochem., 27, (1989), 103

* complete color ** fluid stable


TEST 7 (AMYL) ASSAY CODE (RATE) 2-22-31 SAMPLE VOLUME (µl) 7 R1 VOLUME (µl) 280-NO R2 VOLUME (µl) 70-#-YES R3 VOLUME (µl) ------ WAVELENGTH 1 (nm) 660 WAVELENGTH 2 (nm) 415 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC.- # - # - # FACTOR ** STD-ABS.ALLOWANCE (%) 0 NORMAL RANGE L (U/l) 0 NORMAL RANGE H (U/l) 220 ABS. LIMIT (RATE) 12000 CONTROL ID.NO. #-#-#



#) Data entry by the user *) Calculated by the analyzer **) The factor is approximately – 22000 with conversion and

approximately – 10000 without conversion and must be checked by a calibration serum

10.02.11

844 0821 705

BILIRUBIN AUTO DIRECT FS*


10 082 705 R1 4 x 160 ml + R2 8 x 20 ml

Method Colorimetric test, “DCA (2,4-Dichloroaniline)“

Direct Bilirubin in presence of diazotized 2,4-Dichloroaniline forms a red colored azocompound in acidic solution.


Specimen Serum, heparinized or EDTA plasma. Avoid hemolysis! Store protected from light. Test as soon as possible.

Components and concentration in the test R1: EDTA-Na2 0.07 mmol/l NaCl 6.6 g/l Sulfamic Acid 70 mmol/l R2: 2,4-Dichlorophenyl Diazoniumsalt 0.09 mmol/l HCl 130 mmol/l EDTA-Na2 0.02 mmol/l

Notes Hemoglobin interferes.


A normal range does not exist, false values up to 0.3 mg/dl (5 µmol/l) can occur.

References

1. Rand, R. N., di Pasqua, A., Clin. Chem., 8, (1962), 570 2. Henry, J., Cannon, D. C., Winkelmann, J. V.: Clinical

Chemistry, Principles and Technics, Harper & Row Publishers Inc., Hagerstown Maryland 1974, 1042

3. Thomas, L.: Labor und Diagnose, 4th edition, Die Medizinische

Verlagsgesellschaft, Marburg 1992, 235 * fluid stable


TEST 15 D – BIL ASSAY CODE 1-Endpoint SAMPLE VOLUME (µl) 20 R1 VOLUME (µl) 320-NO R2 VOLUME (µl) 80 - # - YES R3 VOLUME (µl) ----- WAVELENGTH 1 (nm) 660 WAVELENGTH 2 (nm) 546 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC.- # - # - # FACTOR - STD-ABS.ALLOWANCE (%) 10 NORMAL RANGE L 0.0 NORMAL RANGE H 0.3 ABS. LIMIT (RATE) 0 CONTROL ID.NO. #-#-#


CHANNEL NO. # TEST CODE 15 – 15


10.02.11

844 0811 705

BILIRUBIN AUTO TOTAL FS* Order information Cat. No. Kit size 10 081 021 R1 5 x 20 ml + R2 1 x 25 ml 10 081 022 R1 5 x 80 ml + R2 1 x 100 ml 10 081 023 R1 1 x 800 ml + R2 1 x 200 ml

10 081 705 R1 4 x 160 ml + R2 8 x 20 ml

Method Colorimetric test, “DCA (2,4-Dichloroaniline)“

Total Bilirubin in presence of diazotized 2,4-Dichloroaniline forms a red colored azocompound in acidic solution. A specific mixture of detergents enables a safe determination of the Total Bilirubin.

REAGENT PREPARATION AND STABILITY The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. The reagent 2 must be protected from light.

Specimen Serum, heparinized or EDTA plasma. Avoid hemolysis! Store protected from light. Stability: 1 day at 15 – 25 °C 4 days at 2 – 8 °C up to 3 months at - 20 °C (not in case of repeated deep freezing)

Components and concentration in the test R1: TRIS pH 8.2 8 mmol/l NaCl 7 g/l Detergents R2: 2,4-Dichlorophenyl Diazoniumsalt 1 mmol/l HCl 30 mmol/l Detergents

Notes Ascorbic acid and Hemoglobin interfere.

Normal range (see reference 2,3)

Newborn 0 - 24 h: up to 5 mg/dl ( 86 µmol/l) 24 - 48 h: up to 9 mg/dl ( 155 µmol/l) 3 – 5 days: up to 12 mg/dl ( 205 µmol/l) after 4 weeks: up to 1.5 mg/dl ( 26 µmol/l) Adults: up to 1.1 mg/dl (18.8 µmol/l)

References

1. Rand, R. N., di Pasqua, A., Clin Chem., 8, (1962), 570 2. Weigl, E., Bach, H., Krieg, D., Med. Klin., 70, (1975), 664 – 669 3. Keller, H.: Klinisch-chemische Labordiagnostik für die Praxis,

2nd

edition, Georg Thieme Verlag, Stuttgart 1991, 246 * fluid stable


TEST 31 (BILI) ASSAY CODE 1-Endpoint SAMPLE VOLUME (µl) 10 R1 VOLUME (µl) 320-NO R2 VOLUME (µl) 80-#-YES R3 VOLUME (µl) ----- WAVELENGTH 1 (nm) 660 WAVELENGTH 2 (nm) 546 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC.- * # - # - # FACTOR ** STD-ABS.ALLOWANCE (%) 10 NORMAL RANGE L 0.0 NORMAL RANGE H 1.1 ABS. LIMIT (RATE) 0 CONTROL ID.NO. #-#-#


CHANNEL NO. # TEST CODE 31 – 31


10.02.11

844 1100 705

CALCIUM AS FS*

Order information Cat. No. Kit size 1 1130 99 10 021 R 5 x 25 ml + 1 x 3 ml Standard 1 1130 99 10 026 R 6 x 100 ml 1 1130 99 10 023 R 1 x 1000 ml 1 1130 99 10 030 6 x 3 ml Standard

Method Photometric test using arsenazo III

Principle Calcium with Arsenazo III at neutral pH yields a blue colored complex, whose intensity is proportional to the calcium concentration. Interference by magnesium is eliminated by addition of 8-hydroyquinoline-5-sulfonic acid.

Reagent preparation and stability The reagent and standard are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided, stored at 2 – 8 °C and contamination is avoided. Do not freeze the reagents!.

Specimen Serum or heparin plasma. For urine add 10 ml concentrated HCl to the 24 h urine and heat the specimen to dissolve calcium oxalate.

Stability in serum/plasma:

7 days at 20 – 25°C 3 weeks at 2 – 8°C 8 months at -20°C Stability in urine:

2 days at 20 – 25°C 4 days at 2 – 8°C 3 weeks at -20°C

Components and Concentration in the Test Reagent Reagent pH 7.50 Phosphate buffer 50 mmol/l 8-Hydoxyquinoline-5-sulfonic acid 5 mmol/l Arsenazo III 120 µmol/l Detergents

Standard: 10 mg/dl ( 2.5 mmol/l)

Notes 1. As calcium is an urbiquitary ion, essential precaution must be

taken against accidental contaminations. Only use disposable materials.

2. Traces of chelating agent, such as EDTA, can prevent the formation of the colored complex.

3. For detailed product information see detailed package insert.

Reference range

Serum/plasma 8.6 - 10.3 mg/dl (2.15 - 2.57 mmol/l) Urine <250 mg/24h (6.24 mmol/24h)

<300 mg/24h (7.49 mmol/24h)

Performance Characteristics Measuring Range The test has been developed to determine calcium concentrations within a measuring range from 0.04 – 25 mg/dl (0.01 – 6.25 mmol/l). When values exceed this range the samples should be diluted 1+1 with NaCl solution ( 9g/l) and the result multiplied by 2.

Sensitivity / Limit of detection The lower limit of detection is 0.04 mg/dl (0.01 mmol/l) . * fluid stable


TEST 9 (CA) ASSAY CODE 1 SAMPLE VOLUME (µl) 4 R1 VOLUME (µl) 350-NO R2 VOLUME (µl) 1-1-NO R3 VOLUME (µl) ------- WAVELENGTH 1 (nm) 700 WAVELENGTH 2 (nm) 660 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC.- #-#-# FACTOR * STD-ABS.ALLOWANCE (%) 10 NORMAL RANGE L (mg/dl) 8.1 NORMAL RANGE H (mg/dl) 10.4 ABS. LIMIT (RATE) 0 CONTROL ID.NO. #-#-#


CHANNEL NO. TEST CODE 9


10.02.11

844 1100 705

CALCIUM FS*

Order information Cat. No. Kit size 10 110 021 R 5 x 25 ml + 1 x 3 ml standard 1 1100 99 10 026 R 6 x 100 ml 10 110 023 R 1 x 1000 ml 10 110 030 6 x 3 ml standard

10 110 705 R 5 x 180 ml

Method Colorimetric test, “Arsenazo III “

Calcium with Arsenazo III at neutral pH yields a blue colored complex, whose intensity is proportional to the Calcium concentration.

Reagent preparation and stability The reagent is ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided, stored at 15 – 25 °C and protected from light. Stability of standard: until expiry date, when stored at 2 – 25 °C

Specimen Serum; Avoid hemolysis!

Components and concentration in the test Imidazol pH 6.5 100 mmol/l Arsenazo III 120 µmol/l Standard: 10 mg/dl ( 2.5 mmol/l)

Notes 1. As Calcium is an urbiquitary ion, essential precaution must be

taken against accidental contaminations. Only use disposable materials.

2. Traces of chelating agent, such as EDTA, sometimes prevent the formation of the colored complex.

3. The blank absorbance must be < 0.250 at 650 nm.


Serum 8.1 - 10.4 mg/dl (2.02 - 2.60 mmol/l)

References

1. Smith, H. G. Jr., Bauer, P. J., Biochemistry, 18, (1979), 5067 – 5073

2. Caldwell, P. C., in Cuthbert, A. W.: Calcium and Cellular Function, Macmillan, London 1970, 10 – 16

3. Sandell, E. B., Onishi, H.: Photometric determination of traces of metals, 4

th edition, John Wiley & Sons, New York 1978, 459

4. Barnett, R. N., Skodon, S. B., Goldberg, M. H., Amer. J. Clin. Path., 59, (1973), 863

* fluid stable


TEST 9 (CA) ASSAY CODE 1 SAMPLE VOLUME (µl) 4 R1 VOLUME (µl) 350-NO R2 VOLUME (µl) 1-1-NO R3 VOLUME (µl) ------- WAVELENGTH 1 (nm) 700 WAVELENGTH 2 (nm) 660 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC.- #-#-# FACTOR * STD-ABS.ALLOWANCE (%) 10 NORMAL RANGE L (mg/dl) 8.1 NORMAL RANGE H (mg/dl) 10.4 ABS. LIMIT (RATE) 0 CONTROL ID.NO. #-#-#




10.02.11

844 1200 705

CHLORIDE FS*


10 120 705 R 5 x 180 ml

Method Colorimetric test, ”Thiocyanate”

Chloride is releasing equivalent quantities of Thiocyanate from Mercury (II) Thiocyanate. Together with Iron ions Thiocyanate forms a red colored complex. The intensity of the color is proportional to the Chloride concentration.


Specimen Serum, plasma. Avoid hemolysis!

Components and concentration in the test Mercury (II) Thiocyanate 2 mmol/l Mercury (II) Chloride 0.8 mmol/l Ferric (III) Nitrate 20 mmol/l Nitric acid 28 mmol/l Standard: 100 mEq/l (mmol/l)

Notes The reagent contains Mercury (II) Thiocyanate and Mercury (II) Chloride. Do not swallow! Avoid contact with skin and mucous membranes.


Adults: 98 - 110 mEq/l (98 - 110 mmol/l) Children: 95 - 112 mEq/l (95 - 112 mmol/l)

References

1. Schoenfeld, R. G., Lewellen, C. J., Clin. Chem., 10, (1964), 533 2. Witt, I., Trendelenburg, Chr., J. Clin. Chem. Clin. Biochem., 20,

(1982), 235 - 242 * fluid stable


TEST # (Cl)) ASSAY CODE 1 SAMPLE VOLUME (µl) 3 R1 VOLUME (µl) 350-NO R2 VOLUME (µl) 1 – 1 - NO R3 VOLUME (µl) ---- WAVELENGTH 1 (nm) 600 WAVELENGTH 2 (nm) 480 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC.- #-#-# FACTOR * STD-ABS.ALLOWANCE (%) 10 NORMAL RANGE L 98 NORMAL RANGE H 110 ABS. LIMIT (RATE) 0 CONTROL ID.NO. #-#-#


CHANNEL NO. # TEST CODE #


10.02.11

844 1300 705

CHOLESTEROL FS*


10 130 705 R 5 x 180 ml

Method Enzymatic colorimetric test, “CHOD-PAP“

Determination of Cholesterol after enzymatic hydrolysis and oxidation. The colorimetric indicator is Chinonimine which is generated from 4-Aminoantipyrine and Phenol by Hydrogen Peroxide under the catalytic action of Peroxidase.

Reagent preparation and stability The reagent is ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 - 8 °C. The reagent must be protected from light. Stability of standard: until expiry date, when stored at 2 – 25 °C

Specimen Serum, heparinized or EDTA plasma; Avoid hemolysis!

Components and concentration in the test GOOD's buffer pH 6.7 50 mmol/l Phenol 5 mmol/l 4-Aminoantipyrine 0.3 mmol/l Cholesterol Esterase > 200 U/l Cholesterol Oxidase > 50 U/l Peroxidase > 3 KU/l Standard: 200 mg/dl (5.2 mmol/l)

Notes

The reagent contains Sodium Azide (0.095 %) as preservative. Do not swallow! Avoid contact with skin and mucous membranes.

Clinical interpretation (see reference 4)

Suspect: over 220 mg/dl (5.7 mmol/l) Elevated: over 260 mg/dl (6.7 mmol/l) As per recommendation of the European Consensus Conference it is recommendable to lower the Cholesterol level in blood of about 180 mg/dl for adults up to 30 years of age and to about 200 mg/dl for adults of over 30 years of age.

References

1. Richmond, W., Clin. Chem., 19, (1973), 1350 - 1356 2. Roeschlau, P., Bernt, E., Gruber, W., Z. Klin. Chem. Klin.

Biochem, 12, (1974), 403 - 407 3. Trinder, P., Ann. Clin. Biochem., 6, (1969), 24 4. Schettler, G., Nüssel, E., Arbeitsmed. Sozialmed.

Präventivmed., 10, (1975), 25 * fluid stable

HITACHI 705 Chemistry settings Temperature: 37°C

PROGRAM 6: CHEMISTRY PARAMETERS

TEST 11 (CHOL) ASSAY CODE (END POINT) 1 SAMPLE VOLUME (µl) 3

R1 VOLUME (µl) 350 – NO R2 VOLUME (µl) 1 – 1 – NO R3 VOLUME (µl) -------- WAVELENGTH 1 (nm) 700 WAVELENGTH 2 (nm) 505 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC. # - # - # FACTOR * STD-ABS.ALLOWANCE (%) 10 NORMAL RANGE L (mg/dl) 50 NORMAL RANGE H (mg/dl) 220 ABS. LIMIT (RATE) 0 CONTROL ID.NO. # - # - #




10.02.11

844 1651 700

CK-MB FS*


10 165 700 R1 16 x 20 ml + R2 4 x 20 ml

Method Optimized UV test according to the recommendations of the DGKC (German Society of Clinical Chemistry) and IFCC (International Federation of Clinical Chemistry) for CK-NAC. The CK-MB consists of the subunits CK-M and CK-B. A specific antibody against CK-M inhibits the complete CK-MM activity (main part of the total CK activity) and the CK-M subunit of CK-MB. Only CK-B activity is measured, which is half of the CK-MB activity.


Specimen Serum, heparinized or EDTA plasma. Avoid hemolysis! Loss of activity: at 2 – 8 °C after 24 h < 10 %

at 15 - 25 °C after 1 h < 10 %.

Components and concentration in the test R1 + R2 Imidazole pH 6.7 100 mmol/l Creatine Phosphate 30 mmol/l Glucose 20 mmol/l N-Acetyl Cysteine 20 mmol/l Magnesium Acetate 10 mmol/l EDTA 2 mmol/l ADP 2 mmol/l NADP 2 mmol/l AMP 5 mmol/l Diadenosine Pentaphosphate 10 µmol/l Glucose-6-phosphate Dehydrogenase > 1.5 KU/l Hexokinase > 2.5 KU/l CK-M (human) inhibiting polyclonal antibodies (sheep) inhibiting capacity > 2000 U/l

Notes 1. Hemoglobin interferes. 2. The reagents contain Sodium Azide (0.095 %) as preservative.



The likelihood of a cardiac infarction is high under the following circumstances:

CK Women CK Men

37 °C > 167 U/l > 190 U/l

and

CK-MB 37 °C > 24 U/l

and

A CK-MB activity between 6 and 25 % of the Total CK activity

If a cardiac infarction is suspected but the above conditions are not fulfilled, a fresh infarction may have occured. The determination should then be repeated with a fresh sample after 4 hours.

References 1. Würzburg, U., et al., Klin. Wschr., 54, (1976), 357 – 360 2. Würzburg, U., et al.‚ J. Clin. Chem. Clin. Biochem., 15,

(1977), 131 3. Stein, W., Med. Welt., (1985), 572 - 577

* fluid stable


TEST 12 (CK-MB) ASSAY CODE (RATE) 2 – 25 - 31 SAMPLE VOLUME (µl) 13 R1 VOLUME (µl) 280-YES R2 VOLUME (µl) 70-#-YES R3 VOLUME (µl) ------ WAVELENGTH 1 (nm) 376 WAVELENGTH 2 (nm) 340 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC.- 0-0-0 FACTOR ** STD-ABS.ALLOWANCE (%) 0 NORMAL RANGE L (U/l) 0 NORMAL RANGE H (U/l) 24 ABS. LIMIT (RATE) 9000 CONTROL ID.NO. #-#-#



#) Data entry by the user *) Calculated by the analyzer **) The factor is approx. -8375 and must be checked by a calibration serum.

10.02.11

844 1601 705

CK-NAC FS*


10 160 705 R1 4 x 160 ml + R2 8 x 20 ml

Method Optimized UV test according to the DGKC (German Society of Clinical Chemistry) and IFCC (International Federation of Clinical Chemistry).


Specimen

Serum, heparinized or EDTA plasma. Avoid hemolysis! Stability: 1 week at 2 – 8 °C 1 day at 15 – 25 °C

Components and concentration in the test R1 + R2 Imidazole pH 6.7 100 mmol/l Creatine Phosphate 30 mmol/l Glucose 20 mmol/l N-Acetyl Cysteine 20 mmol/l Magnesium Acetate 10 mmol/l EDTA 2 mmol/l ADP 2 mmol/l NADP 2 mmol/l AMP 5 mmol/l Diadenosine Pentaphosphate 10 µmol/l Glucose-6-phosphate Dehydrogenase > 1.5 KU/l Hexokinase > 2.5 KU/l

Notes 1. Hemoglobin up to 200 mg/dl does not interfere. 2. The reagents contain Sodium Azide (0.095 %) as preservative.



37 °C Women < 165 U/l Men < 190 U/l Babies (2 - 12 months) < 325 U/l Children (after 12 months) < 225 U/l

References 1. Recommendations of the German Society of Clinical Chemistry,

J. Clin. Chem. Clin. Biochem., 15, (1977), 255 - 260

2. The Committee on Enzymes of the Scandinavian Society for Clinical Chemistry and Clinical Physiology, Scand. J. Clin. Lab. Invest., 36, (1976), 711

3. Witt, I., Trendelenburg, Chr., J. Clin. Chem. Clin. Biochem., 20, (1982), 235 – 242

4. Chemnitz, G., Schmidt, E., Koller, P. U., Busch, E. W., Dtsch. Med. Wschr., 104, (1979), 257

* fluid stable


TEST 13 (CPK) ASSAY CODE (RATE) 2-22-31 SAMPLE VOLUME (µl) 10 R1 VOLUME (µl) 280-NO R2 VOLUME (µl) 70-1-NO R3 VOLUME (µl) ------- WAVELENGTH 1 (nm) 376 WAVELENGTH 2 (nm) 340 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC.- 0-0-0 FACTOR ** STD-ABS.ALLOWANCE (%) 0 NORMAL RANGE L (U/l) 0 NORMAL RANGE H (U/l) 190 ABS. LIMIT (RATE) 9000 CONTROL ID.NO. #-#-#



#) Data entry by the user *) Calculated by the analyzer **) The factor is approx. -8375 and must be checked by a calibration serum.

10.02.11

844 1711 705

CREATININE FS*

Order information Cat. No. Kit size 10 171 021 R1 4 x 20 ml + R2 1x 20 ml + 1 x 3 ml std. 1 1711 99 10 026 R1 5 x 80 ml + R2 1x 100ml 10 171 023 R1 1 x 800 ml + R2 1x 200ml 10 170 030 6 x 3 ml standard

10 171 705 R1 4 x 160 ml + R2 8 x 20 ml

Method Kinetic test without deproteinisation, “Jaffé“

Creatinine in an alkaline Picrate solution forms a colored orange-red complex. The delta absorbance at fixed times during conversion is proportional to the concentration of Creatinine in the sample.

Reagent preparation and stability The reagents and the standard are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 25 °C.

Specimen

Serum, heparinized plasma, urine. Dilute urine 1 + 49 with dist. water For serum / plasma: Avoid hemolysis! Stability in serum / plasma: 24 hours at 2 – 8 °C

Components and concentration in the test R1: Sodium Hydroxide 0.16 mol/l R2: Pikric acid 4.0 mmol/l Standard: 2 mg/dl (177 µmol/l)

Notes

1. Bilirubin interferes. 2. Reagent 1 contains Sodium Hydroxide. Keep out of the reach of

children. Wear suitable gloves and eye/face protection. In case of contact with eyes rinse immediately with plenty of water and seek medical advice. Remove contaminated clothing immediately.

3. Reagent 2 contains Picric Acid. Toxic by inhalation, in contact with skin and when swallowed. Wear suitable gloves and eye/face protection. After contact with skin, wash immediately with Polyethylenglycol 400 (DAB 8) or plenty of water. If sickness occurs seek medical advice.


Serum: Men 0.6 - 1.1 mg/dl (53 – 97 µmol/l) Women 0.5 - 0.9 mg/dl (44 – 80 µmol/l) Urine: 1000 - 1500 mg/24 h

Creatinine clearance (see reference 4)

Men: 98 – 156 ml/min Women: 95 – 160 ml/min

References

1. Hare, R. S., P. S. E. B. M., 74, (1950), 148 2. Kostir., J. V., Sonka, J., Biochim. Biophys. Acta, 8, (1952), 86 3. Schirmeister, J., Willmann, H., Kiefer, H., Dtsch. Med. Wschr.,

89, (1964), 1018 4. Schirmeister, J., Willmann, H., Kiefer, H., Hallauer, W.,

Dtsch. Med. Wschr., 89, (1964), 1640 5. Sarre, H.: Nierenkrankheiten, Georg Thieme Verlag,

Stuttgart 1959 * fluid stable


TEST 14 (CREA) ASSAY CODE (RATE) 2-19-23 SAMPLE VOLUME (µl) 15 R1 VOLUME (µl) 280-NO R2 VOLUME (µl) 70-1-NO R3 VOLUME (µl) ----- WAVELENGTH 1 (nm) 570 WAVELENGTH 2 (nm) 505 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC.- #-#-# FACTOR ** STD-ABS.ALLOWANCE (%) 10 NORMAL RANGE L 0.5 NORMAL RANGE H 1.1 ABS. LIMIT (RATE) 5500 CONTROL ID.NO. #-#-#




10.02.11

CRP FS* Order information Cat. No. Kit size 1 7002 99 10 015 R1 2 x 25 ml + R2 1 x 10 ml 10 700 021 R1 5 x 25 ml + R2 1 x 25 ml 10 700 023 R1 1 x 1000 ml + R2 1 x 200 ml 1 7000 99 10 039 1 x 2 ml Calibrator Level 1 1 x 2 ml Calibrator Level 2 1 x 2 ml Calibrator Level 3 1 x 2 ml Calibrator Level 4 1 x 2 ml Calibrator Level 5

10 700 705 R1 4 x 160 ml + R2 8 x 16 ml

Method Immunological turbidimetric test

Endpoint determination of the concentration of CRP through photometric measurement of antigen-antibody-reaction. Calculation: 1-point or multi-point calibration

Reagent preparation and stability The reagents and calibrators are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C.

Specimen Serum, heparinized or EDTA plasma. Anticoagulants in usual concentration do not interfere. Avoid hemolysis! Stability: 8 days at 2 - 8 °C 3 months at - 20 °C (not in case of repeated deep freezing)

Prozone limit up to at least 200 mg/dl

Components and concentration in the test R1: Buffer TRIS pH 7.5 100 mmol/l PEG, detergents and stabilizers R2: Antiserum TRIS pH 8.0 100 mmol/l Anti-human CRP antibodies (goat) with stabilizers Calibrators:

stabilized human sera, concentrations are indicated on the label



2. The calibrators were only produced with human sera from donors, where no HIV-antibodies and no HbsAg were detected by FDA-approved tests. As a risk of infection cannot be completely excluded, the calibrators should be handled as carefully as patient samples.


Adults up to 0.8 mg/dl Newborn up to 3 days up to 1.5 mg/dl Infants from the 4

th day and children up to 1.0 mg/dl

References 1. Skurk, A., Thomas, L., Lab. Med., 14, (1990), 111 – 115 2. Grützmeyer, S., von Schenck, H., Clin. Chem., 35,

(1989), 461 - 463 3. Claus, D. R., Osmand, A. P., Gewurz, H., J. Lab. Clin. Med., 87,

(1976), 120 – 128 4. Sabel, K.-G., Wadsworth, Ch., Acta Paediatr. Scand., 68,

(1979), 825 – 831 * fluid stable


TEST # (*) ASSAY CODE 1 SAMPLE VOLUME (µl) 15 R1 VOLUME (µl) 350-NO R2 VOLUME (µl) 70-1-NO R3 VOLUME (µl) ---------- WAVELENGTH 1 (nm) 700 WAVELENGTH 2 (nm) 340 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC. # - # - # FACTOR * STD-ABS.ALLOWANCE (%) 00 NORMAL RANGE L 0 NORMAL RANGE H 0.8 ABS. LIMIT 0 CONTROL ID.NO. # - # - #


CHANNEL NO. # TEST CODE # - #


10.02.11

844 2811 705

GAMMA-GT IFCC FS*


10 281 705 R1 4 x 160 ml + R2 8 x 20 ml

Method Kinetic colorimetric test according to IFCC recommendations (International Federation of Clinical Chemistry)

Gamma-GT catalyzes the transfer of Glutamic acid to acceptors like Glycylglycine in this case. This process releases 5-Amino-2-Nitro-benzoate which absorbs light at 405 nm. The increase in absorbance at this wavelength is directly related to the activity of Gamma-GT.


Specimen Serum, EDTA plasma. Avoid hemolysis. Stability: at least 1 week at between – 20 °C and + 20 °C.

Components and concentration in the test R1: Glycylglycin pH 7.9 150 mmol/l R2: L-Gamma-glutamyl-3-carboxy-

4-nitroanilid 6 mmol/l

Notes The reagents contain Sodium Azide (0.095 %) as preservative. Do not swallow! Avoid contact with skin and mucous membranes.


37 °C Men: 11 - 64 U/l Women: 8 - 45 U/l

References 1. Shaw, L. M., Strømme, J. H., London, J. L., Theodorsen, L.,

J. Clin. Chem. Clin. Biochem., 21, (1983), 633 – 646 2. Lorentz, K., Röhle, G., Siekmann, L., DG Klinische Chemie

Mitteil., 26, (1995), 190 3. S. G. K. C., Bulletin 27, Supplement, (1986), 125 * fluid stable



TEST 16 (GGT) ASSAY CODE 2-19-31 SAMPLE VOLUME (µl) 10

R1 VOLUME (µl) 280-NO R2 VOLUME (µl) 70-1-NO R3 VOLUME (µl) ------ WAVELENGTH 1 (nm) 660 WAVELENGTH 2 (nm) 405 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC. 0-0-0 FACTOR ** STD-ABS.ALLOWANCE 0 NORMAL RANGE L 8 NORMAL RANGE H 64 ABS. LIMIT 5500 CONTROL ID.NO. #-#-#




10.02.11

844 2801 705

GAMMA-GT FS*


10 280 705 R1 4 x 160 ml + R2 8 x 20 ml

Method Kinetic colorimetric test according to Szasz / Persijn (1974)

Gamma-GT catalyzes the transfer of Glutamic acid to acceptors like Glycylglycine in this case. This process releases 5-Amino-2-Nitrobenzoate which absorbs light at 405 nm. The increase in absorbance at this wavelength is directly related to the activity of Gamma-GT.

Reagent preparation and stability The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. Reagent 2 must be protected from light.

Specimen Serum, EDTA plasma. Avoid hemolysis. Stability: at least 1 week at between – 20 °C and + 20 °C.

Components and concentration in the test R1: TRIS buffer pH 8.25 100 mmol/l Glycylglycine 100 mmol/l R2: L-Gamma-glutamyl-3-carboxy-

4-nitroanilide 4 mmol/l

Notes The reagents contain Sodium Azide (0.095 %) as preservative. Do not swallow! Avoid contact with skin and mucous membranes.


37 °C Men: 11 - 50 U/l Women: 7 - 32 U/l

References 1. Szasz, G., Weimann, G., Stähler, F., Wahlefeld, A.-W.,

Persijn, J.-P., Z. Klin. Chem. Klin. Biochem., 12, (1974), 228 2. Persijn, J.-P., van der Slik, W., J. Clin. Chem. Clin. Biochem.,

14, (1976), 421 – 427 3. Szasz, G., Clin. Chem., 15, (1969), 124 – 136 4. Szasz, G., in Bergmeyer, H. U.: Methoden der enzymatischen

Analyse, 3rd edition, Verlag Chemie, Weinheim / Bergstraße

1974, 759 * fluid stable


TEST 16 (GGT) ASSAY CODE (RATE) 2-19-31 SAMPLE VOLUME (µl) 10 R1 VOLUME (µl) 280-NO R2 VOLUME (µl) 70-1-NO R3 VOLUME (µl) ------ WAVELENGTH 1 (nm) 660 WAVELENGTH 2 (nm) 405 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC.- 0-0-0 FACTOR ** STD-ABS.ALLOWANCE (%) 0 NORMAL RANGE L (U/l) 7 NORMAL RANGE H (U/l) 50 ABS. LIMIT (RATE) 5500 CONTROL ID.NO. #-#-#



#) Data entry by the user *) Calculated by the analyzer **) The factor is approx. - 5525 and must be checked by a calibration serum.

10.02.11

844 2500 705

GLUCOSE FS* GOD-PAP


10 250 705 R 5 x 180 ml

Method Enzymatic colorimetric test, “GOD-PAP“

Determination of Glucose after enzymatic oxidation by Glucose oxidase. The colorimetric indicator is Chinonimine, which is generated from 4-Aminoantipyrine and Phenol by Hydrogen Peroxide under the catalytic action of Peroxidase.


Specimen

Serum, heparinized or EDTA plasma. Avoid hemolysis! Separate latest 1 h after blood collection from cellular contents. Stability after addition of a glycolytic inhibitor (NaF, KF): 7 days at 2 – 8 °C 24 h at 15 – 25 °C

Components and concentration in the test Phosphate buffer pH 7.5 250 mmol/l Phenol 5 mmol/l 4-Aminoantipyrine 0.5 mmol/l Glucose Oxidase > 10 KU/l Peroxidase > 1 KU/l Standard: 100 mg/dl (5.55 mmol/l)

Notes

The reagent contains Sodium Azide (0.095 %) as preservative. Do not swallow! Avoid contact with skin and mucous membranes.

Normal range (fasting) (see reference 2)

55 - 115 mg/dl (3.05 – 6.4 mmol/l)

References

1. Barham, D., Trinder, P., Analyst., 97, (1972), 142 - 145 2. Thomas, L.: Labor und Diagnose, 4

th edition, Die Medizinische



TEST 18 (GLUC) ASSAY CODE 1 SAMPLE VOLUME (µl) 4 R1 VOLUME (µl) 400-NO R2 VOLUME (µl) 1-1-NO R3 VOLUME (µl) ------ WAVELENGTH 1 (nm) 700 WAVELENGTH 2 (nm) 505 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC.- #-#-# FACTOR * STD-ABS.ALLOWANCE (%) 10 NORMAL RANGE L 55 NORMAL RANGE H 115 ABS. LIMIT (RATE) 0 CONTROL ID.NO. #-#-#




10.02.11

844 2511 705

GLUCOSE HEXOKINASE FS* Determination without deproteinisation

Order information Cat. No. Kit size 10 251 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3 ml std. 1 2511 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml 10 251 023 R1 1 x 800 ml + R2 1 x 200 ml 10 250 030 6 x 3 ml standard

10 251 705 R1 4 x 160 ml + R2 8 x 20 ml

Method Enzymatic UV test, “Hexokinase“

Hexokinase acts on Glucose to produce Glucose-6-Phosphate and ADP. G-6-PDH catalyzes the change of Glucose-6-Phosphate in presence of NAD

+ to 6-Phospho-Gluconate and NADH.

Reagent preparation and stability The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. The reagents must be protected from light. Stability of standard: until expiry date, when stored at 2 – 25 °C

Specimen Serum, plasma, urine. For serum / plasma: Avoid hemolysis! Separate latest 1 h after blood collection from cellular contents. Stability after addition of a glycolytic inhibitor (NaF, KF): 7 days at 2 – 8 °C 24 h at 15 – 25 °C

Components and concentration in the test R1: TRIS Buffer pH 7.8 80 mmol/l ATP 1.7 mmol/l NAD 1.7 mmol/l Mg

2+ 4 mmol/l

R2: Mg

2+ 4 mmol/l

Hexokinase > 1.5 KU/l Glucose-6-phosphate Dehydrogenase > 1.5 KU/l

Standard: 100 mg/dl (5.55 mmol/l)

Notes The reagents contain Sodium Azide (0.095 %) as preservative. Do not swallow! Avoid contact with skin and mucous membranes!

Normal range (fasting)(see reference 3)

Serum: 55 – 115 mg/dl (3.05 – 6.4 mmol/l) Urin: up to 15 mg/dl (0.84 mmol/l)

References 1. Schmidt, F. H., Klin. Wschr., 39, (1961), 1244 2. Hoffmeister H., Junge, B., Z. Klin. Chem. Klin. Biochem., 8,

(1970), 613 – 617 3. Thomas, L.: Labor und Diagnose, 4




TEST 18 (GLU) ASSAY CODE 1 SAMPLE VOLUME (µl) 5 R1 VOLUME (µl) 320-NO R2 VOLUME (µl) 80-1-NO R3 VOLUME (µl) ------- WAVELENGTH 1 (nm) 376 WAVELENGTH 2 (nm) 340 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC.- #-#-# FACTOR * STD-ABS.ALLOWANCE (%) 00 NORMAL RANGE L 55 NORMAL RANGE H 115 ABS. LIMIT (RATE) 0 CONTROL ID.NO. #-#-#


CHANNEL NO. # TEST CODE 18-18


10.02.11

844 2601 705

GOT (ASAT) IFCC mod. FS* with / without Pyridoxal-5-phosphate


10 260 705 R1 4 x 160 ml + R2 8 x 20 ml

10 501 030 6 x 3 ml For determination with Pyridoxal-5-phosphate activation additionally required: 10 501 030 6 x 3 ml

Method Optimized UV test according to the recommendations of IFCC (International Federation of Clinical Chemistry)


Specimen Serum heparinized or EDTA plasma. Avoid hemolysis! Loss of activity within 3 days at 2 - 8 °C < 8 % and at 15 – 25 °C < 10 %.

Components and concentration in the test R1: TRIS buffer pH 7.8 80 mmol/l L-Aspartate 240 mmol/l MDH > 600 U/l LDH > 600 U/l R2: 2-Oxoglutarate 12 mmol/l NADH 0.18 mmol/l Pyridoxal-5-phosphate FS

GOOD‘s Buffer pH 9.6 0.1 mol/l Pyridoxal-5-phosphate 13.8 mmol/l

Notes 1. For the determination with Pyridoxal-5-phosphate activation a

supplementary kit (Cat. No. 10501030) is necessary. Mix 1 part of P-5-P with 100 parts of Reagent 1. Stability after mixing: 6 days at 2 – 8 °C 24 h at 15 – 25 °C

2. Hemoglobin interferes. 3. The reagents contain Sodium Azide (0.095 %) as preservative.

Do not swallow! Avoid contact with skin and miucous membranes!

Normal range without Pyridoxal-5-phosphate activation

(see reference 1)

37 °C Men up to 37 U/l Women up to 31 U/l

with Pyridoxal-5-phosphate activation (see reference 6)

37 °C Men 10 – 50 U/l Women 10 – 35 U/l

References 1. Wallhöfer, H., et al.: Synopsis der Leberkrankheiten,

Georg Thieme Verlag, Stuttgart 1974 2. Thefeld, W., et al., Dtsch. Med. Wschr., 99, (1974), 343 – 351 3. Bergmeyer, H. U., et al., J. Clin. Chem. Clin. Biochem., 24,

(1986), 497 – 510 4. Deutsche Gesellschaft für Klinische Chemie, Eur. J. Clin.

Chem. Clin. Biochem., 31, (1993), 901 - 909 5. Lorentz, K., Sonntag, O., DG Klinische Chemie Mitteil., 24,

(1993), 101 - 105 6. Lorentz, K., Lübeck, G., Röhle, G., Siekmann, L., DG Klinische

Chemie Mitteil., 26, (1993), 190 * fluid stable


TEST 19 (GOT) ASSAY CODE (RATE) 2-19-31 SAMPLE VOLUME (µl) 20 R1 VOLUME (µl) 280-NO R2 VOLUME (µl) 70-1-NO R3 VOLUME (µl) ------- WAVELENGTH 1 (nm) 376 WAVELENGTH 2 (nm) 340 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC.- 0-0-0 FACTOR ** STD-ABS.ALLOWANCE (%) 0 NORMAL RANGE L (U/l) 0 NORMAL RANGE H (U/l) 37 ABS. LIMIT (RATE) 6000 CONTROL ID.NO. #-#-#



#) Data entry by the user *) Calculated by the analyzer **) The factor is approx. 4375 and must be checked by a calibration serum.

10.02.11

844 2701 705

GPT (ALAT) IFCC mod. FS* with / without Pyridoxal-5-phosphate


10 270 705 R1 4 x 160 ml + R2 8 x 20 ml For determination with Pyridoxal-5-phosphate activation additionally required: 10 501 030 6 x 3 ml

Method Optimized UV test according to the recommendations of IFCC (International Federation of Clinical Chemistry)


Specimen Serum heparinized or EDTA plasma. Avoid hemolysis! Loss of activity within 3 days at 2 - 8 °C < 10 % and at 15 – 25 °C < 17 %.

Components and concentration in the test R1: TRIS buffer pH 7.5 100 mmol/l L-Alanine 500 mmol/l LDH > 1200 U/l

R2: 2-Oxoglutarate 15 mmol/l NADH 0.18 mmol/l

Pyridoxal-5-phosphate FS GOOD‘s Buffer pH 9.6 0.1 mol/l Pyridoxal-5-phosphate 13.8 mmol/l

Notes 1. For the determination with Pyridoxal-5-phosphate activation a

supplementary kit (Cat-No. 10501030) is necessary. Mix 1 part of P-5-P with 100 parts of Reagent 1. Stability after mixing: 6 days at 2 – 8 °C 24 h at 15 – 25 °C

2. The reagents contain Sodium Azide (0.095 %) as preservative. Do not swallow! Avoid contact with skin and miucous membranes!

Normal range without Pyridoxal-5-phosphate activation

(see reference 1)

37 °C Men up to 42 U/l Women up to 32 U/l

with Pyridoxal-5-phosphate activation (see reference 6)

37 °C Men 10 – 50 U/l Women 10 – 35 U/l

References 1. Wallhöfer, H., et al.: Synopsis der Leberkrankheiten,

Georg Thieme Verlag, Stuttgart 1974 2. Thefeld, W., et al., Dtsch. Med. Wschr., 99, (1974), 343 – 351 3. Bergmeyer, H. U., et al., J. Clin. Chem. Clin. Biochem., 24,

(1986), 481 - 493 4. Deutsche Gesellschaft für Klinische Chemie, Eur. J. Clin.

Chem. Clin. Biochem., 31, (1993), 901 - 909 5. Lorentz, K., Sonntag, O., DG Klinische Chemie Mitteil., 24,

(1993), 101 - 105 6. Lorentz, K., Lübeck, G., Röhle, G., Siekmann, L., DG Klinische

Chemie Mitteil., 26, (1993), 190

* fluid stable


TEST 20 (GPT) ASSAY CODE (RATE) 2-19-31 SAMPLE VOLUME (µl) 20 R1 VOLUME (µl) 280-NO R2 VOLUME (µl) 70-1-NO R3 VOLUME (µl) ------ WAVELENGTH 1 (nm) 376 WAVELENGTH 2 (nm) 340 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC.- 0-0-0 FACTOR ** STD-ABS.ALLOWANCE (%) 0- NORMAL RANGE L (U/l) 0 NORMAL RANGE H (U/l) 42 ABS. LIMIT (RATE) 6000 CONTROL ID.NO. #-#-#



#) Data entry by the user *) Calculated by the analyzer **) The factor is approx. 5020 and must be checked by a calibration serum.

10.02.11

844 3521 705

HDL-C IMMUNO FS*

Order information Cat. No. Kit size 1 3521 99 10 021 R1 5 x 20 ml + R2 1 x 25 ml 1 3521 99 10 022 R1 5 x 80 ml + R2 1 x 100 ml 1 3521 99 10 023 R1 1 x 800 ml + R2 1 x 200 ml 1 3520 99 10 065 3 x 3 ml calibrator

1 3521 99 10 705 R1 4 x 160 ml + R2 8 x 20 ml

Method HDL-C Immuno is a homogeneous method without centrifugation step. Antigen – antibody complexes are formed with LDL,VLDL and Chylomicrons in a way that only HDL-C is selectively determined by an enzymatic measurement.

Reagent preparation and stability The reagents and the calibrator are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C.

On board stability: 4 weeks at 2 - 8 °C

Stability of calibrator after reconstitution*:

5 days 1 month

at at

2 - 8 °C - 20 °C

*The calibrator package insert has instructions on handling and reconstitution.

Specimen Serum, heparinized plasma. Avoid hemolysis!

Stability: 1 week at 2 - 8 °C 1 month at below - 20 °C 2 years at below - 70 °C

Components and concentration in the test R1: Good’s Buffer pH 7.0 30 mmol/l 4-Aminoantipyrine 0.54 mmol/l Peroxidase 1440 U/l Ascorbate Oxidase 1620 U/l Anti-human - lipoprotein antibody R2: Good’s Buffer pH 7.0 30 mmol/l Cholesterol Esterase 800 U/l Cholesterol Oxidase 4000 U/l F-DAOS** 0.16 mmol/l Calibrator: as indicated on the label (approx. 50 mg/dl)

Notes The calibrator was only produced with human sera. The human serum used was tested and found negative for HBsAg, anti-HIV antibody and anti-HCV antibody. As a risk of infection cannot be completely excluded, the calibrators should be handled as carefully as patient samples.


Lipid metabolic disorder Cholesterol < 200 mg/dl (5.2 mmol/l) No Triglycerides < 200 mg/dl (2.3 mmol/l)

Cholesterol 200 - 300 mg/dl Yes, if HDL-Cholesterol (5.2 – 7.8 mmol/l) < 35 mg/dl ( 0.9 mmol/l)

Cholesterol > 300 mg/dl (7.8 mmol/l) Yes Triglycerides > 200 mg/dl (2.3 mmol/l)

As per recommendation of the European Consensus Conference it is recommendable to lower the Cholesterol level in blood to about 180 mg/dl for adults up to 30 years of age and to about 200 mg/dl for adults of over 30 years of age.

References 1. Friedewald, W. T., et al., Clin. Chem., 18, (1972), 499 2. Study Group, European Atherosclerosis Society, European Heart

Journal, 8, (1987), 77 – 88 3. Rifal, N., Warnick, G. R., Laboratory Measurement of Lipids,

Lipoproteins and Apolipoproteins. AACC Press. Washington DC, USA 1994

4. Burtis, C. A., Ashwood, E. R., Tietz, N. W.: Textbook of Clinical Chemistry, 2nd edition, W. B. Saunders Company, Philadelphia 1994

5. Gordon, T., Castelli, W. P., Hjortland, M. C., et al., Am. J. Med. 62, (1977), 707 - 714

* fluid stable ** F-DAOS = N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3,5-dimethoxy- 4-fluoroaniline, sodium salt



TEST 22 (HDL) ASSAY CODE 1 SAMPLE VOLUME (µl) 3

R1 VOLUME (µl) 320 – NO R2 VOLUME (µl) 80 – 1 – NO R3 VOLUME (µl) ---- WAVELENGTH 1 (nm) 700 WAVELENGTH 2 (nm) 600 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC. # - # - # FACTOR * STD-ABS.ALLOWANCE 10 NORMAL RANGE L 30 NORMAL RANGE H 85 ABS. LIMIT 0 CONTROL ID.NO. # - # - #


CHANNEL NO. # TEST CODE 22 - 22


10.02.11

844 1911 705


TEST 23 (IRON) ASSAY CODE 1 SAMPLE VOLUME (µl) 20 R1 VOLUME (µl) 320-NO R2 VOLUME (µl) 80-#-NO R3 VOLUME (µl) ------ WAVELENGTH 1 (nm) 700 WAVELENGTH 2 (nm) 600 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC.- #-#-# FACTOR * STD-ABS.ALLOWANCE (%) 10 NORMAL RANGE L 23 NORMAL RANGE H 168 ABS. LIMIT (RATE) 0 CONTROL ID.NO. #-#-#




Sept 2001

IRON FS Ferene Order information Cat. No. Kit size 1 1911 99 10 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3ml Std

1 1911 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml

1 1911 99 10 023 R1 1 x 800 ml + R2 1 x 200 ml

10 190 030 6 x 3 ml Standard

Notes

1. Please refer to the package insert for Iron FS Ferene for

detailed information about the test on the following:

Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding

- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison

Reference Ranges Literature

2. The stability of the reagent on board the analyser is at least

one month provided that contamination and evaporation are avoided.

3. Manufactured by

DiaSys Diagnostic Systems GmbH & Co.KG Alte Strasse 9, 65558 Holzheim, Germany

844 4211 705

LDH DGKC new FS* Standard method 1994

Order information

Cat. No. Kit size 10 421 021 R1 5 x 20 ml + R2 1 x 25 ml 10 421 022 R1 5 x 80 ml + R2 1 x 100 ml 10 421 023 R1 1 x 800 ml + R2 1 x 200 ml

Method Optimized UV test according to the DGKC recommendations (German Society of Clinical Chemistry)


Specimen

Serum, heparinized or EDTA plasma. Avoid hemolysis! Loss of activity within 3 days at 2 - 8 °C < 8 % and at 15 - 25 °C < 2 %.

Components and concentration in the test

R1: N-Methyl-D-Glucamin pH 9.4 325 mmol/l L-Lactate 50 mmol/l R2: NAD

+ 10 mmol/l

Notes

1. Hemoglobin interferes. 2. The reagents contain Sodium Azide (0.095 %) as preservative.



37 °C Men (20 – 60 years) 135 – 225 U/l Woman (20 - 60 years) 135 – 215 U/l

References 1. Deutsche Gesellschaft für Klinische Chemie,

Eur. J. Clin. Chem. Clin. Biochem., 31, (1993), 897 - 899 * fluid stable



TEST 26 (LDH) ASSAY CODE 2-19-31 SAMPLE VOLUME (µl) 6

R1 VOLUME (µl) 280-NO R2 VOLUME (µl) 70-#-NO R3 VOLUME (µl) ------ WAVELENGTH 1 (nm) 376 WAVELENGTH 2 (nm) 340 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC. 0 – 0 - 0 FACTOR ** STD-ABS.ALLOWANCE 10 NORMAL RANGE L 135 NORMAL RANGE H 225 ABS. LIMIT 6000 CONTROL ID.NO. #-#-#




10.02.11

LDL-CHOLESTEROL DIRECT FS*

Order information Cat. No. Kit size 1 4118 99 10 021 R1 4 x 30 ml + R2 2 x 20 ml 1 4118 99 10 022 R1 4 x 90 ml + R2 2 x 60 ml 1 4110 99 10 046 3 x 1 ml standard

Method LDL-Cholesterol Direct is a homogeneous method for directly measuring LDL-C levels without a centrifugation step or indirect calculation. A unique detergent in reagent 1 solubilises only the non-LDL lipoproteins and the Cholesterol released is processed by Cholesterol esterase and Cholesterol oxidase with no colour formation. Another detergent in reagent 2 then acts on the remaining LDL and the released LDL-Cholesterol is then selectively reacted with a Trinder system to produce colour.

Reagent preparation and stability The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. On board stability: 4 weeks at 2 - 8 °C

Stability of standard after reconstitution:

2 weeks

at

2 - 8 °C

Specimen Serum, heparinized or EDTA plasma. Avoid hemolysis!

Stability: 5 days at 2 - 8 °C 3 months at below - 70 °C

Components and concentration in the test R1: Detergent 1 1 % Sodium hydroxide 32.5 mmol/l Cholesterol oxidase > 0.9 KU/l Cholesterol esterase > 0.75 KU/l Ascorbic acid oxidase > 2.25 KU/l Peroxidase > 0.94 KU/l 4-Aminoantipyrine 0.38 mmol/l R2: Detergent 2 1 % N,N-Bis-(4-Sulfobutyl)-m-toluidin Na2

(DSBmT) 0.25 mmol/l

Sodium Hydroxide 32.5 mmol/l Standard: as indicated on the label

Notes 1. The calibrator was only produced with human sera from donors

where no HIV antibodies and no HbsAg were detected by FDA-approved tests. As a risk of infection cannot be completely excluded, the calibrators should be handled as carefully as patient samples.

2. The standard contains Sodium Azide as preservative. Do not swallow! Avoid contact with skin and mucous membranes.

Clinical interpretation

Normal / low risk < 130 mg/dl Borderline high risk 130 - 159 mg/dl High risk > 160 mg/dl

References 1. Badimon, J. J., Badimon, L., Fuester, V., Regression of

Atherosclerotic Lesions by High-Density Lipoprotein Plasma Fraction in the Cholesterol-Fed Rabbit, Journal of Clinical Investigation, 85, (1990), 1234 - 1241

2. Kannel, W. B., Castelli, W. P., Gordon, T., Cholesterol in the prediction of atherosclerotic disease; New perspectives based on the Framingham study, Am. Intern. Med., 90, (1979), 85

3. Tietz, N. W.: Clinical Guide to Laboratory Tests, W. B. Saunders Co., Philadelphia, (1986), 256

* fluid stable



TEST # (LDL) ASSAY CODE 1 Endpoint SAMPLE VOLUME (µl) 3

R1 VOLUME (µl) 330 – NO R2 VOLUME (µl) 110 - # - YES R3 VOLUME (µl) ------ WAVELENGTH 1 (nm) 660 WAVELENGTH 2 (nm) 546 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC. # - # - # FACTOR - STD-ABS.ALLOWANCE 10 NORMAL RANGE L 0 NORMAL RANGE H 130 ABS. LIMIT 0 CONTROL ID.NO. # - # - #




10.02.11

844 4600 705

MAGNESIUM FS*

Order information

Cat. No. Kit size 10 460 021 R 5 x 25 ml + 1 x 3 ml standard 1 4600 99 10 026 R 6 x 100 ml 10 460 023 R 1 x 1000 ml 10 460 030 6 x 3 ml standard

10 460 705 R 5x 180 ml

Method Colorimetric test, “Xylidyl Blue“

Magnesium ions form a purple colored complex with Xylidyl Blue in alkaline solution. In presence of GEDTA, which complexes Calcium ions, the reaction is specific. The intensity of the purple color is proportional to the Magnesium concentration.

Reagent preparation and stability The reagent and standard are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 25 °C.

Specimen

Serum, plasma, CSF and urine. Do not use EDTA plasma! Acidify urine with some drops of conc. HCl to pH 3 – 4 and then dilute 1 + 4 with dist. water. Multiply the result by 5. For serum / plasma: Avoid hemolysis!


TRIS buffer pH 11.0 0.2 mol/l Potassium Carbonate 70 mmol/l GEDTA 40 µmol/l Xylidyl Blue 0.1 mmol/l Standard: 2 mg/dl (0.82 mmol/l)

Notes 1. Hemoglobin interferes. 2. The reagent contains Sodium Azide (0.095 %) as preservative.


3. It is recommended to use disposable plastic material to avoid Magnesium contamination.

Normal range (see reference 3,4,5)

Serum / plasma 1.9 - 2.5 mg/dl (0.8 - 1.0 mmol/l) CSF 0.9 - 3.4 mg/dl (0.38 - 1.4 mmol/l) Urine 0.5 - 10 mg/dl (2.1 - 4.1 mmol/l) 24 h urine 60 - 210 mg/dl (2.5 - 8.5 mmol/l)

References

1. Mann, C. K., Joe, J. H., Anal. Chem., 28, (1956), 202 – 205 2. Mann, C. K., Yoe, J. H., Anal. Chim. Acta, 16, (1957), 155 – 160 3. Bohuon, C., Clin. Chim. Acta, 7, (1962), 811 – 817 4. Keller, H.: Klinisch-chemische Labordiagnostik für die Praxis,

2nd

edition, Georg Thieme Verlag, Stuttgart 1991, 275 5. Sitzmann, F. C.: Normalwerte, Hans Marseille, München 1986 * fluid stable


TEST 28 (MG) ASSAY CODE 1 SAMPLE VOLUME (µl) 4 R1 VOLUME (µl) 350-NO R2 VOLUME (µl) 1-1-NO R3 VOLUME (µl) ------ WAVELENGTH 1 (nm) 700 WAVELENGTH 2 (nm) 546 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC.- #-#-# FACTOR * STD-ABS.ALLOWANCE (%) 10 NORMAL RANGE L 1.9 NORMAL RANGE H 2.5 ABS. LIMIT (RATE) 0 CONTROL ID.NO. #-#-#




10.02.11

844 4600 705

MAGNESIUM XL FS*

Order information

Cat. No. Kit size 1 4610 99 10 021 R 5 x 25 ml + 1 x 3 ml standard 1 4610 99 10 026 R 6 x 100 ml 1 4610 99 10 023 R 1 x 1000 ml 1 4610 99 10 030 6 x 3 ml standard

Method Photometric test using xylidyl blue.

Principle Magnesium ions form a purple colored complex with xylidyl blue in alkaline solution. In presence of GEDTA, which complexes calcium ions, the reaction is specific. The intensity of the purple color is proportional to the magnesium concentration.

Reagent preparation and stability The reagent and standard are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. Do not freeze the reagents!

Specimen

Serum, plasma, cerebrospinal fluid (CSF) and urine. Do not use EDTA plasma. Acidify urine with some drops of conc. HCl to pH 3 – 4 and then dilute 1 + 4 with dist. water. Multiply the result by 5.

Stability in serum/plasma:

7 days at 20 – 25°C 7 days at 2 – 8°C 1 year at -20°C

Stability in urine:

3 days at 20 – 25°C 3 days at 2 – 8°C 1 year at -20°C

Components and Concentration in the Test

Reagent Reagent pH 11.0 Ethanolamine 1 mol/l GEDTA 60 µmoll Xylidyl blue 110 µmol/l Detergents Standard: 2 mg/dl (0.82 mmol/l)

Notes 1. Hemoglobin interferes. 2. For detailed product information see package insert

Reference range

Serum / plasma Neonates 1.2 – 2.6 mg/dl (0.48 – 1.05 mmol/l) Children 1.5 – 2.3 mg/dl (0.60 – 0.95 mmol/l) Women 1.9 – 2.5 mg/dl (0.77 – 1.03 mmol/l) Men 1.8 – 2.6 mg/dl (0.73 – 1.06 mmol/l) Urine 73 – 122 mg/24 h (3 – 5 mmol/24 h CSF 2.1 – 3.3 mg/dl (0.85 – 1.35 mmol/l)

Performance Characteristics

Measuring Range The test has been developed to determine magnesium concentrations within a measuring range from 0.05 – 5 mg/dl (0.02 – 2.05 mmol/l). When values exceed this range samples should be diluted 1+4 with NaCl solution ( 9g/l) and the result multiplied by 5.

Sensitivity / Limit of detection The lower limit of detection is 0.05 mg/dl (0.02 mmol/l) fluid stable


TEST 28(MG) ASSAY CODE 1 SAMPLE VOLUME (µl) 4 R1 VOLUME (µl) 350-NO R2 VOLUME (µl) 1-1-NO R3 VOLUME (µl) --- WAVELENGTH 1 (nm) 700 WAVELENGTH 2 (nm) 546 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC.- #-#-# FACTOR * STD-ABS.ALLOWANCE (%) 10 NORMAL RANGE L 1.9 NORMAL RANGE H 2.5 ABS. LIMIT (RATE) 0 CONTROL ID.NO. #-#-#




10.02.11

RHEUMATOID FACTOR FS*

Order information Cat. No. Kit size 1 7022 99 10 015 R1 2 x 25 ml + R2 1 x 10 ml 1 7022 99 10 021 R1 5 x 25 ml + R2 1 x 25 ml

1 7020 99 10 059 1 x 1 ml Calibrator level 1 1 x 1 ml Calibrator level 2 1 x 1 ml Calibrator level 3 1 x 1 ml Calibrator level 4 1 x 1 ml Calibrator level 5

Method Immunological turbidimetric test

Endpoint determination of the concentration of RF through photometric measurement of antigen-antibody-reaction. Calculation: Multi-point calibration

Reagent preparation and stability The reagents and calibrators are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. Do not freeze the reagents!

Specimen Serum, heparinized or EDTA plasma. Anticoagulants in usual concentration do not interfere. Do not use sodium fluoride blood collection bottles. Stability: 3 days at 2 - 8 °C 1 day at 20 – 25 °C 4 weeks at - 20 °C

Prozone limit No prozone effect observed up to a RF concentration of 3000 IU/ml.

Components and concentration in the test R1: Phosphate buffer pH 7.4 25 mmol/l R2: Glycine buffer pH 7.4 25 mmol/l Heat aggregated human IgG 0.17 mg/ml Calibrators: Stabilised human plasma

Activity stated on the label

Notes 1. The reagents and caloibrators contain Sodium Azide (0.095 %)

as preservative. Do not swallow! Avoid contact with skin and mucous membranes.

2. The calibrators were only produced with human plasma which were found to be nonreactive for HBsAg , anti-HIV 1+2 and anti-HCV when tested by FDA accepted methods. As no test can offer complete assurance that products derived from human blood will not transmit infectious agents, it is recommended that the calibrators should be handled with the same precautions used for patient specimens.

Normal range Adults Less than 35 IU/ml

References 1. Sharp, J. T., Calkins, R., Cohen, A. S., Schubart, A. F.,

Calabro, J. J. , Medicine, 43, (1964), 41 2. Freyberg, R. H., Postgrad., Med. 51, (1972), 22 3. Kunkel, H. G., Williams, R. C. Ann. Rev. Med., 15, (1964), 37-

52 4. Winchester, R. J., Ann. N. Y. Acad. Sci. 256, (1975), 73 - 81 5. Bulletin on Rheumatic Diseases, Volume VII; Bunim, J. J., ed.

Arthritis and Rheumatism Foundation 1956, 121 * fluid stable



TEST RF ASSAY CODE 1 SAMPLE VOLUME (µl) 20

R1 VOLUME (µl) 350 – YES R2 VOLUME (µl) 70 - # - YES R3 VOLUME (µl) WAVELENGTH 1 (nm) 700 WAVELENGTH 2 (nm) 340 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC. # - # - # FACTOR * STD-ABS.ALLOWANCE 10 NORMAL RANGE L 0 NORMAL RANGE H 35 ABS. LIMIT 0 CONTROL ID.NO. # - # - #



#) Data entry by the user *) Calculated by the analyzer **) Calibrator value

10.02.11

844 2311 705

TOTAL PROTEIN FS* Order information Cat. No. Kit size 10 231 021 R1 4 x 20 ml + R2 1x 20 ml + 1 x 3 ml std 1 2311 99 10 026 R1 5 x 80 ml + R2 1x 100 ml 10 231 023 R1 1 x 800 ml + R2 1x 200 ml 10 230 030 6 x 3 ml standard

10 231 705 R1 4 x 160 ml + R2 8 x 20 ml

Method Colorimetric test, “Biuret“

Proteins together with Copper ions form a violet blue complex in alkaline solution. The absorbance of the color is directly proportional to the concentration.

Reagent preparation and stability The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 25 °C. Stability of standard: until expiry date, when stored at 2 – 8 °C

Specimen

Serum or plasma. Avoid hemolysis!


R1: Sodium Hydroxide 80 mmol/l Potassium Sodium Tartrate 12.8 mmol/l R2: Sodium Hydroxide 100 mmol/l Potassium Sodium Tartrate 16 mmol/l Potassium Iodide 15 mmol/l Copper Sulphate 6 mmol/l Standard: 5 g/dl

Notes

1. Serum or plasma from patients who have received large intravenous amounts of Polydextrans yields values which are too high with the Biuret method. In such cases the protein concentration should be determined by an alternative method (e. g. Kjeldahl).

2. The reagents contain Sodium Hydroxide. Do not swallow! If the reagents come in contact with skin of mucous membranes rinse immediately with water!


Adults: 6,2 – 8,4 g/dl Children 1 day – 4 weeks: 4,52 – 6,86 g/dl 2 – 12 months: 4,57 – 7,33 g/dl > 12 months: 5,85 – 8,01 g/dl

References

1. Henry, R. J., Sobel, C., Berkmann, S., Anal. Chem., 29, (1957), 1491

2. Peters, T., Clin. Chem., 14, (1968), 1147 3. Keller, H.: Klinisch-chemische Labordiagnostik für die Praxis,

2nd

edition, Georg Thieme Verlag, Stuttgart 1991, 263 * fluid stable


TEST 32 (TP) ASSAY CODE 1 SAMPLE VOLUME (µl) 7 R1 VOLUME (µl) 320 - NO R2 VOLUME (µl) 80 - 1 - NO R3 VOLUME (µl) ------ WAVELENGTH 1 (nm) 700 WAVELENGTH 2 (nm) 546 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC.- #-#-# FACTOR * STD-ABS.ALLOWANCE (%) 10 NORMAL RANGE L 6.2 NORMAL RANGE H 8.4 ABS. LIMIT (RATE) 0 CONTROL ID.NO. #-#-#


CHANNEL NO. # TEST CODE 32 - 32


10.02.11

844 0210 705

TOTAL PROTEIN IN URINE FS* Order information Cat. No. Kit size 1 0210 99 10 021 R 5 x 25 ml + 1 x 3 ml standard 1 0210 99 10 026 R 6 x 100 ml 1 0210 99 10 023 R 1 x 1000 ml 1 0210 99 10 030 6 x 3 ml standard

10 021 705 R 5 x 180 ml

Method Colorimetric test, “Pyrogallol Red“

Proteins together with Pyrogallol Red / Molybdate form a red complex. The color is directly proportional to the protein concentration.

Reagent preparation and stability The reagent and standard are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. The reagent must be protected from light.

Specimen Urine, cerebro-spinal fluid

Components and concentration in the test Pyrogallol Red 50 µmol/l Sodium Molybdate 40 µmol/l Detergents Standard: 0.2 g/l (200 mg/l)


Urine 40 – 80 mg/24 h Cerebro-spinal fluid (liquor) up to 500 mg/l * *This value is only to be taken as a guide line. Reference values are declared for liquor / serum quotients on the general package insert. Liquor / serum quotients for albumin:

30th week of pregnancy < 50 x 10

-3

Birth < 25 x 10-3

1 month < 15 x 10-3

6 months < 5 x 10-3

20 years < 5 x 10-3

40 years < 7 x 10-3

60 years < 8 x 10-3

These values are approximately equal to the liquor / serum quotient of Total Protein. For exact calculation refer to the following table:

Q (Albumin) Q (Total Protein) 7 x 10

-3 8 x 10

-3

10 x 10-3

11 x 10-3

20 x 10

-3 18 x 10

-3

50 x 10-3

40 x 10-3

References 1. Fujita, Y., Mori, I., Kitano, S., Bunseki Kakagu, 32, (1983), 379

– 386 2. Orsonneau, J.-L., Douet, P., Massoubre, C., Lustenberger, P.,

Bernard, S., Clin. Chem., 35, (1989), 2233 3. Watanabe, N., Kamei, S., Ohkubo, A., Yamanaka, M., Ohsawa,

S., Makino, K., Tokuda, K., Clin Chem., 32, (1986), 1551 4. Guder, W. G., Hofmann, W., Weber, M. H.: Kleinkonferenz

“Proteinurie“, DG Klinische Chemie Mitteil., 22, (1991), 78 5. Thomas, L.: Labor und Diagnose, 4


Verlagsgesellschaft, Marburg 1992, 1716

* fluid stable



TEST # (#) ASSAY CODE 1 SAMPLE VOLUME (µl) 6

R1 VOLUME (µl) 350 – NO R2 VOLUME (µl) 0 – 1 – NO R3 VOLUME (µl) ------- WAVELENGTH 1 (nm) 700 WAVELENGTH 2 (nm) 600 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC. # - # - # FACTOR * STD-ABS.ALLOWANCE 10 NORMAL RANGE L 40 NORMAL RANGE H 80 ABS. LIMIT 0 CONTROL ID.NO. # - # - #


CHANNEL NO. # TEST CODE #


10.02.11

844 5710 705

TRIGLYCERIDES FS* Order information Cat. No. Kit size 10 571 021 R 5 x 25 ml + 1 x 3 ml standard 1 5710 99 10 026 R 6 x 100 ml 10 571 023 R 1 x 1000 ml 10 570 030 6 x 3 ml standard

10 571 705 R 5 x 180 ml

Method Colorimetric enzymatic test, “GPO“

Determination of Triglycerides after enzymatic splitting with Lipoprotein Lipase. Indicator is Chinonimine, which is generated from 4-Aminoantipyrine and Phenol by Hydrogen Peroxide under the catalytic action of Peroxidase.

Reagent preparation and stability The reagent and standard are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. The reagent must be protected from light.

Specimen

Serum, heparinized or EDTA plasma. Avoid hemolysis!


GOOD‘ s buffer pH 7.2 50 mmol/l 4-Chlorophenol 4 mmol/l

Mg2+ 15 mmol/l

ATP 2 mmol/l Glycerokinase > 0.4 KU/l Peroxidase > 2 KU/l Lipoprotein Lipase > 2 KU/l 4-Aminoantipyrine 0.5 mmol/l Glycerol-3- phosphate Oxidase > 0.5 KU/l Standard: 200 mg/dl (2.3 mmol/l)

Notes

1. To correct for free Glycerol, subtract 10 mg/dl (0.11 mmol/l) from the Triglycerides result.

2. Ascorbic acid interferes. 3. The reagent contains Sodium Azide (0.095 %) as preservative.

Do not swallow! Avoid contact with skin and mucous membranes !


Suspect over: 150 mg/dl (1.71 mmol/l) Increased over: 200 mg/dl (2.28 mmol/l)

References

1. Schettler, G., Nüssel, E., Arbeitsmedizin Sozialmedizin Präventivmedizin, 10, (1975), 25

2. Jacobs, N. J., Vandemark, P. J., Arch. Biochem. Biophys., 88, (1960), 250 – 255

3. Trinder, P., Ann. Clin. Biochem., 6, (1969), 24 4. Koditschek, L. K., Umbreit, W. W., Journ. of Bacteriol., 98,

(1969), 1063 - 1068 * fluid stable



TEST 33 (TRIG) ASSAY CODE 1 SAMPLE VOLUME (µl) 4 R1 VOLUME (µl) 350-NO R2 VOLUME (µl) 1-1-NO R3 VOLUME (µl) ------ WAVELENGTH 1 (nm) 700 WAVELENGTH 2 (nm) 505 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC. #-#-# FACTOR * STD-ABS.ALLOWANCE 10 NORMAL RANGE L 50 NORMAL RANGE H 200 ABS. LIMIT 0 CONTROL ID.NO. #-#-#




10.02.11

844 3101 705

UREA FS*

Order information

Cat. No. Kit size 10 310 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3 ml std. 1 3101 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml 10 310 023 R1 1 x 800 ml + R2 1 x 200 ml 10 310 030 6 x 3 ml standard

10 310 705 R1 4 x 160 ml + R2 8x 20 ml

Method Enzymatic UV test, “Urease - GLDH“

Urease acts on Urea to produce Ammonium and Carbonate ions. Glutamic Dehydrogenase catalyzes the oxidation of Ammonium ions with 2-Oxoglutarate and NADH under formation of Glutamate. The decrease of NADH is proportional to the Urea concentration.

Reagent preparation and stability The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. Stability of standard: until expiry date, when stored at 2 – 25 °C

Specimen

Serum, plasma (no Ammonium Heparin), fresh urine. For serum / plasma: Avoid hemolysis! Dilute urine 1 + 100 with dist. water Stability in serum / plasma: 1 week at 2 – 8 °C 2 days at 15 – 25 °C

Components and concentration in the test R1: Tris buffer pH 7.8 120 mmol/l 2-Oxoglutarate 7 mmol/l ADP 0.6 mmol/l Urease > 6 KU/l GLDH > 1 KU/l R2: NADH 0.25 mmol/l Standard: 50 mg/dl (8.33 mmol/l)

Notes

1. The reagents contain Sodium Azide (0.095 %) as preservative. Do not swallow! Avoid contact with skin and mucous membranes!

2. To convert Urea into BUN multiply by 0.47; to convert BUN into Urea multiply by 2.14.


Serum / plasma: 10 - 50 mg/dl (1.7 - 8.3 mmol/l) Urine: 20 - 35 g/24 h (333 - 583 mmol/24 h)

References

1. Talke, H., Schubert, G. E., Klin. Wschr., 43, (1965), 174 2. MacKay, E. M., MacKay, L. L., J. Clin. Invest., 4, (1927), 295 3. Sarre, H.: Nierenkrankheiten, Georg Thieme Verlag,

Stuttgart 1959 * fluid stable


TEST 8 (BUN) ASSAY CODE (RATE) 2-19-22 SAMPLE VOLUME (µl) 3 R1 VOLUME (µl) 280-NO R2 VOLUME (µl) 70-1-NO R3 VOLUME (µl) ------ WAVELENGTH 1 (nm) 376 WAVELENGTH 2 (nm) 340 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC.- #-#-# FACTOR * STD-ABS.ALLOWANCE (%) 10 NORMAL RANGE L 10 NORMAL RANGE H 50 ABS. LIMIT (RATE) 9000 CONTROL ID.NO. #-#-#




10.02.11

844 3021 705

URIC ACID FS* TBHBA

Order information Cat. No. Kit size 10 302 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3 ml std. 1 3021 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml 10 302 023 R1 1 x 800ml + R2 1 x 200 ml 10 300 030 6 x 3 ml standard

10 302 705 R1 4 x 160ml + R2 8x 20 ml

Method Enzymatic colorimetric test, “TBHBA“

Uric acid is oxidized to Allantoine by Uricase. The generated Hydrogen Peroxide reacts with 4-Aminoantipyrine and 2,4,6-Tribromo-3-hydroxybenzoic acid (TBHBA) to Chinonimine.

Reagent preparation and stability The reagents and the standard are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. The reagents must be protected from light.

Specimen

Serum, heparinized or EDTA plasma, urine. For serum / plasma: Avoid hemolysis! Dilute urine 1 + 10 with distilled water.


R1: Phosphate buffer pH 7.0 100 mmol/l TBHBA (2,4,6-Tribromo-3-Hydroxy-

benzoic acid) 1 mmol/l

R2: Phosphate buffer pH 7.0 100 mmol/l 4-Aminoantipyrine 0,3 mmol/l Potassiumhexacyanoferrate (II) 10 µmol/l POD > 2 KU/l Uricase > 30 U/l Standard: 6 mg/dl (357 µmol/l)

Notes

Ascorbic acid interferes.


Serum: Men: 3.4 - 7.0 mg/dl (200 - 420 µmol/l) Women: 2.4 - 5.7 mg/dl (140 - 340 µmol/l) Urine: 250 - 750 mg/24 h (1.5 - 4.5 mmol/24 h)

References

1. Thefeld, W., Hoffmeister, H., Busch, E.-W., Koller, P. U., Vollmar, J., Dtsch. Med. Wschr., 98, (1973), 380 – 384

2. Henry, R. J., Cannon, D. C., Winkelmann, J.: Clinical Chemistry, Principles and Technics, 2

nd edition, Harper & Row Publishers

Inc., Hagerstown Maryland 1974, 534 3. Trinder, P., Ann. Clin. Biochem., 6, (1969), 24 - 27 4. Town, M.-H., Gehm, S., Hammer, B., Ziegenhorn, J.,

J. Clin. Chem. Clin. Biochem., 23, (1985), 591 * fluid stable

HITACHI 705 Chemistry settings with sample blank Temperature: 37°C PROGRAM 6: CHEMISTRY PARAMETERS

TEST 34 (UA) ASSAY CODE 1 SAMPLE VOLUME (µl) 5 R1 VOLUME (µl) 320-NO R2 VOLUME (µl) 80-1-NO R3 VOLUME (µl) ----- WAVELENGTH 1 (nm) 660 WAVELENGTH 2 (nm) 505 RGT.BLK.ABS * RGT.BLK.CONC. 0 STD.CONC.- #-#-# FACTOR * STD-ABS.ALLOWANCE (%) 10 NORMAL RANGE L 2.4 NORMAL RANGE H 7.0 ABS. LIMIT (RATE) 0 CONTROL ID.NO. #-#-#




10.02.11

705 ALBUMIN FS - Asterisco€¦ · 844 0220 705 ALBUMIN FS Order information Cat. No. Kit size...

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Transcript of 705 ALBUMIN FS - Asterisco€¦ · 844 0220 705 ALBUMIN FS Order information Cat. No. Kit size...