TM STANDARD F hs-CRP Control€¦ · 2. Sample well STANDARD F FIA Test High sensitive lateral flow...
2
Quality approved by SD BIOSENSOR / For In vitro use only hs-CRP Control STANDARD TM F hs-CRP Control STANDARD F PLEASE READ INSTRUCTIONS CAREFULLY BEFORE YOU PERFORM THE TEST EXPLANATION AND SUMMARY [Intended use] STANDARD F hs-CRP Control is designed to monitor the performance of STANDARD F hs-CRP and STANDARD F Analyzer. During operation of the STANDARD F Analyzer, at least two levels of an appropriate quality control reagent should be tested on a regular basis. Quality control testing should be performed in accordance with regulatory requirements and each laboratory’s standard procedure. [Test principle] Two different levels of control help monitoring the performance of STANDARD F hs-CRP. The range of each control is indicated on the bottle with a bar code which contains necessary information to process the quality control assessment. Both level 1 & level 2 tests should be separately performed in order, and results of the test should be within the given ranges. ACTIVE INGREDIENTS OF MAIN COMPONENT [Contents] ① STANDARD F hs-CRP Control – Level 1 : 10 tablets in the bottle (White colored tube) ② STANDARD F hs-CRP Control – Level 2 : 10 tablets in the bottle (Red colored tube) ③ Instructions for use [Reagents composition] This product is composed of human hs-CRP protein with other preservatives and stabilizers. The range of control level is indicated on the label of the each bottle. Components Composition (per 1 tablet) Level 1 control tablet Low level of human hs-CRP protein Level 2 control tablet High level of human hs-CRP protein [Materials required but not provided] • STANDARD F Analyzer • STANDARD F hs-CRP test kit STORAGE AND STABILITY Store the STANDARD F hs-CRP Control at 2-30°C / 36-86°F. Do not freeze the test kit. The hs-CRP test kit is stable until expiration date printed on the outer box. WARNINGS AND PRECAUTIONS 1. Check the expiration date on the test kit, and do not use expired product. 2. If there is an evidence of microbial contamination or excessive turbidity, discard the control bottle. 3. The control bottle itself is a dehumidifier. Cap the control bottle tightly to maintain the quality. CONTROL TEST PROCEDURE [Preparation] 1. Expose STANDARD F hs-CRP test kit and STANDARD F hs- CRP Control at room temperature (15-30°C/ 59-86°F) at least 30 minutes prior to the test. 2. Carefully read instructions to use. 3. Check the expiration date of the control on the bottle and of the test device on the pouch. Do not use expired controls or test devices. / LOT No. / MFG DATE / EXP DATE / REF No. / Item ML25RT7MLR1 Issue date : 2017.10 xxxxxxxxxxxx xxxx.xx.xx xxxx.xx.xx XXXXXXX XXXXXXX 4. Open the foil pouch, and check the components. [Test device, Spoit TM (Pink), Silica gel] <Test device> <Spoit™ (Pink)> <Foil pouch> hs-CRP 1. Result window 2. Sample well STANDARD F FIA Test High sensitive lateral flow technology with advanced fluorescence detection system <Silica gel> Yellow Green Yellow : Valid Green : Invalid CAUTION • Do not write on the bar code, or damage the barcode of the test device. [Sample preparation] 1. Open the level 1 control bottle, and take a tube out. 2. Put a control tablet into the extraction buffer tube of the STANDARD F hs-CRP. 3. Slightly shake the buffer tube to dissolve the control tablet. SHAKE 4. By using the Spoit TM (Pink), carefully press and release the pink rubber 6-8 times. Mix carefully to avoid bubble forming. 5. Collect all the mixture with the Spoit TM (Pink). Put in 7-8 times mix [Sample preparation] • Using the STANDARD F100 Analyzer 1. Prepare the STANDARD F100 Analyzer, and select the “STANDARD TEST” mode on the screen. 2. Insert the test device into the test slot. After “Device Checking” process, select the “Serum/Plasma” as sample, and then press the right button (►) to conduct the control test. 3. Apply the sample mixture into the sample well of the test device. 4. Immediately press the center button to start the test. 5. The analyzer will automatically display the test result after 3 minutes. 6. Check the test result whether it is within the given range on the label of the control bottle. If the result is out of range, repeat the test. If the re-test value is also unacceptable, please contact the customer service center. / Lot No : XXXXXXXXXXXX Control Range : XX~XX ng/mL XXXXXX / MFG : XXXX.XX.XX / EXP : XXXX.XX.XX LOT 7. Perform the same test with a Level 2 control tablet to see the performance of a high value. / Lot No : XXXXXXXXXXXX Control Range : XX~XX ng/mL XXXXXX / MFG : XXXX.XX.XX / EXP : XXXX.XX.XX LOT • Using the STANDARD F200 Analyzer 1. Prepare the STANDARD F200 Analyzer, and select the “QC” mode on the screen. C-F-HCRP
Transcript of TM STANDARD F hs-CRP Control€¦ · 2. Sample well STANDARD F FIA Test High sensitive lateral flow...
Quality approved by SD BIOSENSOR / For In vitro use only
hs-CRP ControlSTANDARDTM F hs-CRP Control
STANDARD F
PLEASE READ INSTRUCTIONS CAREFULLY BEFORE YOU PERFORM THE TEST
EXPLANATION AND SUMMARY[Intended use]STANDARD F hs-CRP Control is designed to monitor the performance of STANDARD F hs-CRP and STANDARD F Analyzer. During operation of the STANDARD F Analyzer, at least two levels of an appropriate quality control reagent should be tested on a regular basis. Quality control testing should be performed in accordance with regulatory requirements and each laboratory’s standard procedure.
[Test principle]Two different levels of control help monitoring the performance of STANDARD F hs-CRP. The range of each control is indicated on the bottle with a bar code which contains necessary information to process the quality control assessment. Both level 1 & level 2 tests should be separately performed in order, and results of the test should be within the given ranges.
ACTIVE INGREDIENTS OF MAIN COMPONENT[Contents] ① STANDARD F hs-CRP Control – Level 1 : 10 tablets in the bottle (White colored tube)② STANDARD F hs-CRP Control – Level 2 : 10 tablets in the bottle (Red colored tube)③ Instructions for use
[Reagents composition]This product is composed of human hs-CRP protein with other preservatives and stabilizers.The range of control level is indicated on the label of the each bottle. Components Composition (per 1 tablet)Level 1 control tablet Low level of human hs-CRP proteinLevel 2 control tablet High level of human hs-CRP protein
[Materials required but not provided] • STANDARD F Analyzer• STANDARD F hs-CRP test kit
STORAGE AND STABILITYStore the STANDARD F hs-CRP Control at 2-30°C / 36-86°F. Do not freeze the test kit. The hs-CRP test kit is stable until expiration date printed on the outer box.
WARNINGS AND PRECAUTIONS1. Check the expiration date on the test kit, and do not use expired product. 2. If there is an evidence of microbial contamination or excessive turbidity, discard the control bottle.3. The control bottle itself is a dehumidifier. Cap the control bottle tightly to maintain the quality.
CONTROL TEST PROCEDURE[Preparation]1. Expose STANDARD F hs-CRP test kit and STANDARD F hs-
CRP Control at room temperature (15-30°C/ 59-86°F) at least 30 minutes prior to the test.
2. Carefully read instructions to use. 3. Check the expiration date of the control on the bottle
and of the test device on the pouch. Do not use expired controls or test devices.
/ Item
/ LOT No./ MFG DATE/ EXP DATE
/ REF No.
/ Item
ML25RT7MLR1Issue date : 2017.10
xxxxxxxxxxxxxxxx.xx.xxxxxx.xx.xx
XXXXXXX
XXXXXXX
4. Open the foil pouch, and check the components. [Test device, SpoitTM (Pink), Silica gel]
<Test device><Spoit™ (Pink)><Foil pouch>
hs-CRP
1. Result window
2. Sample well
STANDARD F
FIA TestHigh sensitive lateral flow technology with advanced fluorescence detection system
The Global Standard Founder
TM
<Silica gel>
Yellow
Green
Yellow : ValidGreen : Invalid
CAUTION
• Do not write on the bar code, or damage the barcode of the test device.
[Sample preparation]1. Open the level 1 control bottle, and take a tube out.
2. Put a control tablet into the extraction buffer tube of the STANDARD F hs-CRP.
3. Slightly shake the buffer tube to dissolve the control tablet.
SHAKE
4. By using the SpoitTM (Pink), carefully press and release the pink rubber 6-8 times. Mix carefully to avoid bubble forming.
5. Collect all the mixture with the SpoitTM (Pink).
Put in 7-8 times mix
[Sample preparation]• Using the STANDARD F100 Analyzer 1. Prepare the STANDARD F100 Analyzer, and select the
“STANDARD TEST” mode on the screen.
2. Insert the test device into the test slot. After “Device Checking” process, select the “Serum/Plasma” as sample, and then press the right button (►) to conduct the control test.
3. Apply the sample mixture into the sample well of the test device.
4. Immediately press the center button to start the test.
5. The analyzer will automatically display the test result after 3 minutes.
6. Check the test result whether it is within the given range on the label of the control bottle. If the result is out of range, repeat the test. If the re-test value is also unacceptable, please contact the customer service center.
/ Lot No : XXXXXXXXXXXX
Control Range : XX~XX ng/mL
XXXXXX
/ MFG : XXXX.XX.XX
/ EXP : XXXX.XX.XX
LOT
7. Perform the same test with a Level 2 control tablet to see the performance of a high value.
/ Lot No : XXXXXXXXXXXX
Control Range : XX~XX ng/mL
XXXXXX
/ MFG : XXXX.XX.XX
/ EXP : XXXX.XX.XX
LOT
• Using the STANDARD F200 Analyzer 1. Prepare the STANDARD F200 Analyzer, and select the “QC”
mode on the screen.
C-F-HCRP
STANDARDTM F hs-CRP Control
2. Select the “Control ID” column, then scan the bar code of the level 1 control, or manually enter the bar code numbers. Operator ID and Control Order are optional. Press “Direct” for a next step.
3. Insert the test device into the test slot of the analyzer
4. Apply the sample mixture into the sample well of the test device. Then, immediately press the start button.
5. The analyzer will automatically display the test result after 3 minutes. hs-CRP
2:58
6. The test result will be concluded “Passed” or “Failed” with a quantitative value. If the result is out of range(Failed), repeat the test. If the re-test value is also unacceptable, please contact the customer service center. [hs-CRP]
hs-CRP:
0.1 - 3.0
Passed (1.30 mg/L)
7. Perform the same test with a Level 2 control tablet to see the performance of a high value.
/ Lot No : XXXXXXXXXXXX
Control Range : XX~XX ng/mL
XXXXXX
/ MFG : XXXX.XX.XX
/ EXP : XXXX.XX.XX
LOT
Product DisclaimerWhilst every precaution has been taken to ensure the diagnostic ability and accuracy of this product, the product is used outside of the control of the SD BIOSENSOR and distributor and the result may accordingly be affected by environmental factors and/or user error. A person who is the subject of the diagnosis should consult a doctor for further confirmation of the result.
WarningThe SD BIOSENSOR and distributors of this product shall not be liable for any losses, liability, claims, costs or damages whether direct or indirect of consequential arising out of or related to an incorrect diagnosis, whether positive or negative, in the use of this product.
Reference number In vitro Diagnos�cs Do not re-use.
To indicate the temperature limita�ons in which the transport package has to be kept and handled.
Consult Instruc�ons for Use Contains Sufficient for <n> Tests
ManufacturerBatch codeUse byCau�on Date of manufacture Note
Fulfill the requirements ofDirec�ve 98/79/EC on in vitro diagnos�cmedical devices
Manufactured by Head office : C-4th&5th, 16, Deogyeong-daero 1556beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16690, REPUBLIC OF KOREA Manufacturing site : 74, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28161, REPUBLIC OF KOREA
Authorized Representative
Altenhofstrasse 80 D-66386 St. Ingbert GermanyPhone : +49 6894 581020, Fax : +49 6894 581021
Any inquiries regarding instructions provided should be addressed to: [email protected] you can also contact us through www.sdbiosensor.com
L24HSC1ENR0 Issue date: 2018.03
![STANDARD™ F D-dimer FIA CAUTIOND-dimer levels rise during pregnancy and high levels are associated with complications. [Intended use] STANDARD F D-dimer FIA is an in vitro diagnostic](https://static.fdocuments.in/doc/165x107/5e245a9d8893db4d306c0295/standarda-f-d-dimer-fia-caution-d-dimer-levels-rise-during-pregnancy-and-high.jpg)
![UCLA Statistics | Websitesczhu/papers/concept.pdfa zoj k f U hªg a j a fia j a e/f p j g fia elh+je/f aFg \ a WDr ntwVn r n W g UKk U%] f pde/g a XlU f nta j elpdp U f W X a ntf j](https://static.fdocuments.in/doc/165x107/6022c8808689a05080719140/ucla-statistics-sczhupapersconceptpdf-a-zoj-k-f-u-hg-a-j-a-fia-j-a-ef-p.jpg)
