1. CM-BAND ANATOMIC PATHOLOGY EDUCATION PROGRAMSSURVEYS 2013Clinical MicroscopyPARTICIPANT SUMMARY 0.25 Hours of Self-Reported Training Available This document is available on e-LAB Solutions. 2013 College of American Pathologists. The College does not permit reproduction of any substantial portion of the material in this Report without its written authorization. The College hereby authorizes participants in the program to use the material in this Report solely for educational purposes within their own institutions. The College prohibits use of the material in the Report and any unauthorized use of the Colleges name or logo in connection with promotional efforts by marketers of laboratory equipment, reagents, materials, or services. Data from this program do not necessarily indicate the superiority or inferiority of instruments, reagents, or other materials used by participating laboratories. Use of these data to suggest such superiority or inferiority may be deceptive and misleading. The College will take all steps open to it under the law to prevent unauthorized reproduction of substantial portions of the material in this Report, deceptive use of any such material, and any unauthorized use of the Colleges name or logo in connection with promotional efforts by marketers of laboratory equipment, reagents, materials, or services.

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TABLE OF CONTENTS Program Update ........................................................................................................................................................ 1 Evaluation Criteria ..................................................................................................................................................... 2 CMP/CMP1 Clinical Microscopy Bilirubin .................................................................................................................................................................. 34 Bilirubin, IRIS iChemVELOCITY and iChem 100 (CMP1 only)............................................................................. 40 Blood or Hemoglobin ............................................................................................................................................. 42 Glucose ................................................................................................................................................................. 19 Ketones ................................................................................................................................................................. 26 Leukocyte Esterase ............................................................................................................................................... 49 Nitrite ..................................................................................................................................................................... 57 Osmolality ................................................................................................................................................................ 3 pH, Urine ............................................................................................................................................................... 10 Protein (Qualitative) ............................................................................................................................................... 13 Reducing Substance ............................................................................................................................................. 25 Specific Gravity........................................................................................................................................................ 7 Urobilinogen .......................................................................................................................................................... 60 Urine hCG................................................................................................................................................................ 4 Urine Sediment Photographs ................................................................................................................................ 63 Body Fluid Photographs ........................................................................................................................................ 67 Case Discussion: Pneumocystis in BAL ............................................................................................................... 73 CMMP Clinical Microscopy Miscellaneous Photographs ...................................................................................... 75 OCB Occult Blood.................................................................................................................................................. 81 GOCB Gastric Occult Blood Gastric Occult Blood .............................................................................................................................................. 82 Gastric pH.............................................................................................................................................................. 83 DSC Dipstick Confirmatory Bilirubin, Confirmatory ........................................................................................................................................... 84 Protein, Confirmatory ............................................................................................................................................ 84 Actions Laboratories Should Take when a PT Result is Not Graded ....................................................................... 85 Attestation of Participation for Self-Reported Training ............................................................................................. 86 HEMATOLOGY AND CLINICAL MICROSCOPY RESOURCE COMMITTEE Joan E. Etzell, MD, FCAP, Chair Sherrie L. Perkins, MD, PhD, FCAP, Vice Chair Kyle T. Bradley, MD, MS, FCAP David R. Czuchlewski, MD, FCAP John L. Frater Jr., MD, FCAP Tracy I. George, MD, FCAP George M. Girgis, MT Eric D. Hsi, MD, FCAP David F. Keren, MD, FCAP Martina Lefterova, MD, PhDJennifer L. Oliveira, MD, FCAP Jay L. Patel, MD, FCAP Janet Piscitelli, MD, FCAP Kathryn A. Rizzo, DO, PhD, FCAP Luke R. Shier, MD, FCAP Anna K. Wong, MD, FCAP David L. Zwick, MD, FCAP Maria A. Proytcheva, MD, FCAP, Liaison 3. 2013 CM-B PARTICIPANT SUMMARY Program UpdateDont Miss Out on this Educational Opportunity! With your participation in CAPs Surveys programs, every member of your team can take part in education activities: earn Continuing Education (CE) credits or receive Self-Reported Training* at no additional charge. This Survey mailing includes a Self-Reported Training activity. By reviewing the discussion that begins on page 63, your laboratory staff can earn 0.25 education hours that can be used towards fulfilling education and certification maintenance requirements. For your convenience, a form has been included to document your staffs participation in the activity. See page 86. *CAP Self-Reported Training activities do not offer CE credit, but can be used towards fulfilling requirements for certification maintenance by agencies such as the American Society of Clinical Pathology (ASCP). Please verify with your certifying agency to determine your education requirements.1 4. Evaluation CriteriaQUALITATIVE For qualitative procedures in urinalysis, evaluation is based on participant consensus by method and instrument. For each analyte, a minimum of two, but not more than four, responses will be given a passing score. Analyte results graded Good performance must have 80% participant consensus. Eighty percent participant consensus can be determined by grouping the mode with the next one or two most frequent responses. This group will be given Good performance. Acceptable performance will be given to additional responses until a minimum of 90% of participant results are given a passing score. In the case of a negative specimen, negative responses must constitute 90% participant consensus. Specimens with results for one of more methods distributed over both negative and positive responses (non-consensus) will not be evaluated. Specimens for which there is greater than 90% of participant responses distributed over more than four responses will be graded as Non-consensus. Analyte Bilirubin, Confirmatory Gastric Occult Blood Gastric pH Nitrate Occult Blood Protein, Confirmatory Urine hCG QUANTITATIVE Analyte Gastric pH Osmolality Specific GravityEvaluation Criteria 80% overall participant consensus/intended response 80% overall participant consensus/intended response 80% overall participant consensus/intended response 80% overall participant consensus/intended response 80% overall participant consensus/intended response 80% overall participant consensus/intended response 80% overall participant consensus/intended responseTarget Value Peer Group Mean Peer Group Mean Peer Group MeanEvaluation Criteria 3 SD 3 SD 2 SD or 0.010, whichever is greaterLow and high values shown in the Participant Summary indicate the range of values reported. Low and high limits of acceptability are shown on the evaluation report. Data are not included for methods used by fewer than 10 laboratories.PHOTOGRAPHS Photographs are evaluated for CAP purposes according to 80% or greater consensus of either referees or participant laboratories. "Good" performance is given for the intended response. Additionally, the Hematology and Clinical Microscopy Resource Committee may, at its discretion, grant either "good" or "acceptable" performance for other equivalent responses. To provide a timely evaluation of your results, statistics presented in this Participant Summary reflect a minimum of 80% of participant enrollment. In the event a result is not graded, a numeric code will appear next to your result. A definition of the code will appear on the first page of the evaluation. Please see Actions Laboratories Should Take when a PT Result is Not Graded on page 85. 2 5. No. LabsMeanS.D.C.V.CM-14Advanced Instruments ARKRAY Fiske Precision Systems997 50 84 25866.4 862.8 868.1 857.54.8 3.7 6.3 7.90.6 0.4 0.7 0.9CM-15Advanced Instruments ARKRAY Fiske Precision Systems1001 49 86 25763.7 763.0 765.2 758.24.0 3.1 4.7 5.40.5 0.4 0.6 0.7CM-16Osmolality - mOsm/kg (mmol/kg)Advanced Instruments ARKRAY Fiske Precision Systems1001 51 85 25418.0 419.5 420.2 414.03.7 3.1 4.5 7.10.9 0.7 1.1 1.73 6. Urine hCG The hCG level was intended to be positive.CM-14ManufacturerManufacturer's Stated Sensitivity Level mIU/mLAbbott TestPack Plus Combo w/ or w/out OBC Acceava Combo II ACON One Step (urine only) Alere hCG Cassette (20) (Acceava) Alere hCG Cassette (25) (Clearview) Alere hCG Combo Cassette (20/10) Alere hCG Combo Cassette (25) (Clearview) Beckman Coulter ICON 20 Beckman Coulter ICON 25 Cardinal Health SP Brand Cassette Cardinal Health SP Brand Combo Cen-Med Elite Plus One Step hCG Clearview hCG Combo II Eiken Meridian ImmunoCard STAT Polymedco Poly stat (serum/urine) Quidel QuickVue One-Step Combo Quidel QuickVue One-Step Urine Quidel QuickVue+ One-Step Combo Ramco Quik-Trak Combi Test (serum/urine) Randox Direct SA Scientific (SAS) Ultra SA Scientific (serum/urine) Sekisui OSOM Sekisui OSOM Combo Siemens Clinitek Status Stanbio QuPID Stanbio QuPID Plus Stanbio QuPID Plus E.R. Stanbio True 20 Plus Sure-Vue (urine only) Sure-Vue (serum/urine) Sure-Vue STAT (serum/urine) Technologist Choice (serum/urine) Other and Methods with 600 or 1000 mg/dL1-1-4296------8249-2-1-144121---1-43 11 83 6 693 7 73 27 122 -1 1---153381-1---28279-21 3 11 ---13 2 832 12 918 53 43 456 46-1 1 1 6* Not appropriate for Roche Urisys 1100 users.17 20. Protein Qualitative, Method 2CM-16Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual75 mg/dL 10-20 30-70 (Roche Negative mg/dL mg/dL only)*100-200 mg/dL300-600 mg/dL500 mg/dL (IRIS only)*>600 or 1000 mg/dL----33833615-----257-----79153-----1 3 -135 18 152 33 183 -1 2-----9111----2245-631 -1 ---2 24 2 130 55 849 469 36-1 4 1 25* Not appropriate for Roche Urisys 1100 users.18 21. Glucose, Method 1CM-14Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status VisualNegativeTrace1+2+3+4+10 10-----220-----10-----11 10-----10 10-----28-----25-3---92-----100 89 23 32--1 -1-30-----220-----22 23 453 17 390 94---1 --19 22. Glucose, Method 1CM-15Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status VisualNegativeTrace1+2+3+4+10 10-----220-----10-----11 10-----10 10-----28-----27-1---92-----99 89 23 33-----30-----219-----22 23 453 17 389 93-----20 23. Glucose, Method 1CM-16Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual4+NegativeTrace1+2+3+--10 10----11231941---64---11 10-----10 10------262---16183-1-28721 1 --1 1 1 180 20 5 115 61 14 112 6 3 20---5223--191281-1 4 2 -5 2 210 7 122 14 244 349 11 294 3 128 332 4 26 12 171 3 1 721 24. Glucose, Method 2CM-14Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status VisualNegative30-100 mg/dL150-300 mg/dL500* mg/dL>500 or 1000 or 2000 mg/dL463----543---171----144 17 165 33 70--1 --95----323----33 54 897 482 139-1 -1 --*Roche Glucose Visual Users: Results may be reported as 500 mg/dL. All other Roche Glucose Method users should NOT report 500 mg/dL. Analyzers are not able to discern results of 500 vs. 1000 mg/dL.22 25. Glucose, Method 2CM-15Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status VisualNegative30-100 mg/dL150-300 mg/dL500* mg/dL>500 or 1000 or 2000 mg/dL4621---561---171----145 17 166 33 70----94----323----33 54 897 481 1381 -11 1 --*Roche Glucose Visual Users: Results may be reported as 500 mg/dL. All other Roche Glucose Method users should NOT report 500 mg/dL. Analyzers are not able to discern results of 500 vs. 1000 mg/dL.23 26. Glucose, Method 2CM-16Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual>500 or 1000 or 2000 mg/dLNegative30-100 mg/dL150-300 mg/dL500* mg/dL--438205--20352--431136-1 -126 14 145 26 101 2 2016 3 19 7 40--22172-12902831 7 3 -1 7 5 115 10 231 273 4114 29 583 178 543 14 71 24 44*Roche Glucose Visual Users: Results may be reported as 500 mg/dL. All other Roche Glucose Method users should NOT report 500 mg/dL. Analyzers are not able to discern results of 500 vs. 1000 mg/dL.24 27. Reducing SubstanceCM-14Method/Instrument Bayer Clinitest, 2 Drop* Visual Bayer Clinitest, 5 Drop Siemens Clinitek 500, Advantus VisualCM-15Method/Instrument Bayer Clinitest, 2 Drop* Visual Bayer Clinitest, 5 Drop Siemens Clinitek 500, Advantus VisualCM-16Method/Instrument Bayer Clinitest, 2 Drop* Visual Bayer Clinitest, 5 Drop Siemens Clinitek 500, Advantus Visual% Negative (Trace)%%*1%2%2031----11 21891-121%%*1%2%% Negative (Trace)1995----11 21858--1-%%*1%2%% Negative (Trace)24115491331212392 2395 12344 660* Please note % is not an appropriate response for the Bayer Clinitest, 2-drop method.25 28. Ketones, Method 1CM-14Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Visual Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 500, Advantus Siemens Clinitek Status VisualNegativeTraceSmall----10 10---144----10 10----10----10--52211 ---1 1 39 16 12---6131 3-4 1 -29 2 726 38 9626ModerateLarge 29. Ketones, Method 1CM-15Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Visual Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 500, Advantus Siemens Clinitek Status VisualNegativeTraceSmallModerateLarge10 10----45----10 10----10----10----28----10 18 15----19----60 40 102--1227 30. Ketones, Method 1CM-16*Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Visual Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 500, Advantus Siemens Clinitek Status VisualNegativeTraceSmallModerateLarge10 10-----3402-10 10----10----10-----1711---1 1 17 9 82 8 51-127--5 4 6440 22 2414 11 71 2 71 1 4* Specimen CM-16 was not graded due to lack of participant consensus.28 31. Ketones, Method 2CM-14Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status VisualNegativeTrace1+2+3+4+2--142272---73----226----1712-1-10696-1-1 23 9 13100 37 16 671 60 ----2314---6516012 -1 -15 1 -5 1 265 3 22 416 16 152 13 228 431 2 111 529 32. Ketones, Method 2CM-15Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status VisualNegativeTrace1+2+3+4+245-----10-----28-----29-----86-----104 97 26 82-1---37-----225-----21 18 438 16 362 51--1--30 33. Ketones, Method 2CM-16*Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status VisualNegativeTrace1+2+3+4+-3228122--37---271------281---48354--1 144 258 26 24 4542 47 1 2123 11 ---4303-712794---34 22 2715 9 279 12 140 146 9 124 4 186 42 15 43-* Specimen CM-16 was not graded due to lack of participant consensus.31 34. Ketones, Method 3CM-14Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status VisualCM-15Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status VisualNegative5-10 mg/dL1--15-20 mg/dL40 - 60 mg/dL80 - 100 mg/dL1143723---39141-1811261--1 -4 5 2 91 2 -125 12 136 19--1--86--18920531 -1 -1 11 -6 6 486 26 618 47 339 319 454 1 7 119 16Negative5-10 mg/dL15-20 mg/dL40 - 60 mg/dL80 - 100 mg/dL150 mg/dL390---1-53-----147-----131 17 140 28-----87-----299-----31 54 842 463 67----1 1 -32150 mg/dL 35. Ketones, Method 3CM-16*Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual5-10 mg/dL15-20 mg/dL-221157---80 - 100 mg/dL150 mg/dL121-4423-7568-2-1 1 -6 5 3 -74 9 76 2449 3 59 41 -1 --19752-91721112--2 3 70 30 3523 27 472 204 206 23 289 205 84 14 41 --Negative* Specimen CM-16 was not graded due to lack of participant consensus.3340 - 60 mg/dL 36. Bilirubin, Method 1CM-14Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Ictotest Visual Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status VisualCM-15Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Ictotest Visual Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status VisualNegativeTrace/SmallPositive/ModerateLarge370---28 29---20---320---11---32 54 862 492 1151 -3 -2 -NegativeTrace/SmallPositive/ModerateLarge370---27 29---20---320---11---32 53 865 492 115-1 -1 -34 37. Bilirubin, Method 1CM-16Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Ictotest Visual Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status VisualNegativeTrace/Small2-51317--10 1317 16-1415211621531-643 12 -4 3 640 8 828 51 225 481 10635Positive/ModerateLarge 38. Bilirubin, Method 2CM-14Method/Instrument ACON Mission Reagent Sticks ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status VisualNegativeTrace1+2+3+4+10 10-----208---2-10-----11 11-----10-----10-----27-----100 10 83 22 90-1---32-----207-----20 15 375 16 300 66-1 -1 --1 -36 39. Bilirubin, Method 2CM-15Method/Instrument ACON Mission Reagent Sticks ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status VisualNegativeTrace1+2+3+4+10 10-----210-----10-----11 11-----10-----10-----27-----99 10 83 22 91--1 ---32-----206-----20 15 377 16 301 66-----37 40. Bilirubin, Method 2CM-16Method/Instrument ACON Mission Reagent Sticks ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status VisualNegativeTrace1+2+3+4+----10 10--13-57149----10----111 10-----10-----10-4---23--1-3 2 -99 7 80 22 901 1 -----32---11119411 --1 -3 264 7 1 516 15 112 9 298 571 438 41. Bilirubin, Method 3CM-14Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Roche Urisys Cassette Roche Urisys 2400CM-15Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Roche Urisys Cassette Roche Urisys 2400CM-16Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Roche Urisys Cassette Roche Urisys 2400Negative0.5 -1.0 mg/dL2.0 4.0 mg/dL6.0 10.0 mg/dL>10.0 mg/dL81----111 16 132 27----67----Negative0.5 -1.0 mg/dL2.0 4.0 mg/dL6.0 10.0 mg/dL>10.0 mg/dL81----111 16 131 27--1 --67----Negative0.5 -1.0 mg/dL2.0 4.0 mg/dL6.0 10.0 mg/dL>10.0 mg/dL--11367---111 16 129 273 --1-66-39 42. Bilirubin, IRIS iChemVELOCITY and iChem 100, Method 1CMP1-04Method/Instrument IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITYCMP1-05Method/Instrument IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITYCMP1-06Method/InstrumentNegativeTrace/SmallPositive/ModerateLarge28---146---NegativeTrace/SmallPositive/ModerateLarge28---147---NegativeIRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITYTrace/SmallPositive/ModerateLarge1-10162251136Bilirubin, IRIS iChemVELOCITY and iChem 100, Method 2CMP1-04Method/Instrument IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITYCMP1-05Method/Instrument IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITYCMP1-06Method/Instrument IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITYNegativeTrace1+2+3+4+17-----61--1--1+2+3+4+NegativeTrace17-----62--1--1+2+3+NegativeTrace4+---31313-753--40 43. Bilirubin, IRIS iChemVELOCITY and iChem 100, Method 3CMP1-04Method/Instrument IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITYCMP1-05Method/Instrument IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITYCMP1-06Method/Instrument IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITYNegative0.5 -1.0 mg/dL2.0 4.0 mg/dL6.0 10.0 mg/dL>10.0 mg/dL22----25----Negative0.5 -1.0 mg/dL2.0 4.0 mg/dL6.0 10.0 mg/dL>10.0 mg/dL22----25----Negative0.5 -1.0 mg/dL2.0 4.0 mg/dL6.0 10.0 mg/dL>10.0 mg/dL--22--2-23--41 44. Blood or Hemoglobin, Method 1CM-14Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status VisualCM-15Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status VisualMarked Positive/Moderate Positive/LargeNegativeTrace/Small12197159---401212429---24 24---181-83021 -26 38 57 332 51 842 418 143NegativeTrace/Small-130454--6341212132-1-24 23---181-93011 1 -1 1 -3 8 38 86 929 48 840 386 13942Marked Positive/Moderate Positive/Large 45. Blood or Hemoglobin, Method 1CM-16Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status VisualMarked Positive/Moderate Positive/LargeNegativeTrace/Small-295262--238-29262--1 -23 24---181-3307-1 1 22 20 17 232 56 859 457 14443 46. Blood or Hemoglobin, Method 2CM-14Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status VisualNegativeTrace1+2+3+4+5+----10 10-----1461081-----11 11------10------10-----523----1527----26818--1 1 ---7 610 7 10101 32 14 1847 -----131941-152242-1 --12 13 54 120 15 419 16 299 751 1 21 2 244 47. Blood or Hemoglobin, Method 2CM-15Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status VisualNegativeTrace1+2+3+4+5+----10 10-----21540------11 11------10------10-----226----1626----26620---1-8 411 8 11100 31 14 1847 -----112141-162222-11 --1 4 9 1 92 319 12 423 15 262 731 2 21 1 245 48. Blood or Hemoglobin, Method 2CM-16Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status VisualNegativeTrace1+2+3+4+5+----10 10-----69186------11 11------10------10------28----1230----25234--11 --7 510 6 1 10100 34 14 1847 -----11214---22292-1 1 ---3 16 120 17 429 15 337 741 1 41 2 246 49. Blood or Hemoglobin, Method 3 5 25CM-14 CM-15Method/Instrument Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Reagent Strips Siemens Clinitek 500, Advantus Siemens Clinitek StatusCM-16Method/Instrument Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Reagent Strips Siemens Clinitek 500, Advantus Siemens Clinitek StatusNegativeEry/LEry/LEry/L1 1 --1 2 1 -106 16 139 33 64---71-12 830 2950 150250NegativeEry/LEry/LEry/L--1 2 1108 17 138 34 631--70-12 930 285 25Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Reagent Strips Siemens Clinitek 500, Advantus Siemens Clinitek Status2505 25Method/Instrument50 15050 150250NegativeEry/LEry/LEry/L--1 2 1 -107 16 139 34 64---71112 230 3447 50. Blood or Hemoglobin, Method 4CM-14Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITYCM-15Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITYCM-16Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY0.03 mg/dLNegative0.06 0.10 mg/dL0.20 0.50 mg/dL1.0 mg/dL---3130---210---1080.06 0.10 mg/dL0.20 0.50 mg/dL1.0 mg/dL0.03 mg/dLNegative---4813---111---1080.06 0.10 mg/dL0.20 0.50 mg/dL1.0 mg/dL0.03 mg/dLNegative---1051----12---9948 51. Leukocyte Esterase, Method 1CM-14Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status VisualNegativeTraceLargePositive*----10 10---113541----10 10-----10-----10-----37-1---140111--5 616 112 ----414--1-1228511 -1 -4 8 4 107 214 31 695 188 5112 19 180 176 792 4 1* Appropriate for IRIS iChemVELOCITY and iChem 100 users only.49SmallModerate 52. Leukocyte Esterase, Method 1CM-15Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status VisualNegativeTraceSmallModerateLargePositive*10 10-----357--1--10 10-----10-----10-----3322---1511----23 17-1---18-----299-----30 56 879 475 1291 1 11-2 1-* Appropriate for IRIS iChemVELOCITY and iChem 100 users only.50 53. Leukocyte Esterase, Method 1CM-16Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Status VisualNegativeTraceSmall----10 10---333501----10 10-----10-----10----136----413711---4 617 112 1---513--1-9620111 1 11 4 15 38 711 46 456 403 7618 3 401 4 385 6 31 92 1 1* Appropriate for IRIS iChemVELOCITY and iChem 100 users only.51ModerateLargePositive* 54. Leukocyte Esterase, Method 2CM-14Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual1+2+3+4+Positive*--61858----46------20------16-1---2831---1 3106 29 8 703 59 13 171 -1 ----2016--1--7216211 1 -2 -1 1 3 76 -17 11 345 168 475 5 79 16 118 311 1 2 --NegativeTrace1* Appropriate for IRIS iChemVELOCITY and iChem 100 users only.52 55. Leukocyte Esterase, Method 2CM-15Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 ** IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status VisualNegativeTrace1+2+3+4+Positive*199---1--10------20------1223----86------111 89 21 90------36------224-1-1--23 18 430 16 365 771 ---1--* Appropriate for IRIS iChemVELOCITY and iChem 100 users only. ** Specimen CM-15 for this peer group was not graded due to lack of participant consensus.53 56. Leukocyte Esterase, Method 2CM-16Method/Instrument ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status VisualNegativeTrace1+2+3+4+Positive*---71858----73-----317------16-1---3821---2 1 20105 29 7 612 59 13 91 -1 1 ----2016-----91134111 111 15 510 16 228 328 4711 1 189 7 8 222 1 3 8 13 31 --* Appropriate for IRIS iChemVELOCITY and iChem 100 users only.54 57. Leukocyte Esterase, Method 3 2575 or 100NegativeLL1--250 or 500Positive*-1134--301---27-1 --1 -106 17 144 321---71----12---17 1914 6-75 or 100NegativeLL250 or 500116-28ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 500, Advantus Siemens Clinitek StatusMethod/InstrumentCM-15L25CM-14Method/InstrumentARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 500, Advantus Siemens Clinitek StatusLPositive*-2-3---27----107 17 144 33--1 --71----12----31 25----* Appropriate for IRIS iChemVELOCITY and iChem 100 users only.55 58. Leukocyte Esterase, Method 3 25CM-16Method/Instrument75 or 100NegativeLL---ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 500, Advantus Siemens Clinitek Status250 or 500LPositive*-1153--301---27---1 -107 17 144 321--269---39--328 204 1-* Appropriate for IRIS iChemVELOCITY and iChem 100 users only.56 59. NitriteCM-14Method/InstrumentNegativeACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (8007212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status VisualPositive1678-11-11 11-10 10-23-8512591 -241 26 245 56 99-125-5361 2 -5711 1054 77 1339 18 861 210 60. NitriteCM-15Method/InstrumentNegativeACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (8007212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status VisualPositive2677-11-11 11-10 10122-8512591 2 -240 26 244 56 99-12525335 4 25811 1054 76 1333 18 859 208 61. NitriteCM-16*Method/InstrumentNegativeACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Urocheck Reagent Strips Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (8007212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status VisualPositive-11 103675101-11 11-10 10221176823237225 23 193 54 8315 3 53 2 1610815-5361 2 8 2 11 9553 75 1330 16 852 114* Specimen CM-16 was not graded due to lack of participant consensus.59 62. UrobilinogenCM-14Method/Instrument ACON Mission Reagent Strips ACON Mission U120, U500 Visual ARKRAY Aution Sticks ARKRAY/IRIS Aution Max/iQ200 BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer CTMI / Thermo Fisher Reagent Strips CTMI CT-120 Urine Analyzer Visual Diagnostic Test Group Clarity Diagnostic Test Group Clarity Urocheck 120 Visual Eiken Uropaper Eiken US-3100R/3100Rplus IRIS iChem Reagent Strips IRIS iChem 100 IRIS iChemVELOCITY Reagent Strips (800-7212) IRIS iChemVELOCITY Roche Chemstrip/Combur Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys 1800 Roche Urisys 1100 Visual Roche Urisys Cassette Roche Urisys 2400 Siemens Clinitek Atlas Reagent Siemens Clinitek Atlas Siemens Reagent Strips Siemens Clinitek 10 or 100 Siemens Clinitek 50 Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual1.0 Negative 4.0 8.0 or mg/dL or or 0.0 - 0.2 or 2.0/3.0 4.0/6.0 12.0