Surveys and Anatomic Pathology Education Programs. Urine Dipstick Competency Challenge POC3-B Intended Response
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1 Surveys and Anatomic Pathology Education Programs Urine Dipstick Competency Challenge POC3-B 2016 Intended Response This document is available on e-lab Solutions 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 College s 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 College s name or logo in connection with promotional efforts by marketers of laboratory equipment, reagents, materials, or services.
2 Osmolality - mosm/kg (mmol/kg) No. Labs Mean S.D. C.V. Advanced Instruments ARKRAY Fiske Precision Systems Urine hcg The hcg level was intended to be positive. Manufacturer's Stated Sensitivity Level Manufacturer miu/ml Positive Abbott TestPack Plus Combo w/ or w/out OBC 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) Alere hcg Dipstick Beckman Coulter ICON Beckman Coulter ICON Cardinal Health SP Brand Cassette Cardinal Health SP Brand Combo Cen-Med Elite Plus One Step hcg Clearview hcg Combo II Consult Diagnostics Cassette Consult Diagnostics Combo Consult Diagnostics Dipstick Eiken Ekla Novaplus hcg Combo Henry Schein OneStep+ Urine Cassette Innovatek BioStrip LifeSign Status (serum/urine) Meridian ImmunoCard STAT Polymedco Poly stat Quidel QuickVue One-Step Combo Quidel QuickVue One-Step Urine Quidel QuickVue+ One-Step Combo Quidel Sofia Ramco Quik-Trak Combi Test (serum/urine) SA Scientific (SAS) Ultra SA Scientific (Serum/Urine) Sekisui OSOM
3 Urine hcg (cont ) The hcg level was intended to be positive Manufacturer's Stated Sensitivity Level Manufacturer miu/ml Positive Sekisui OSOM Combo Siemens Clinitek Status Stanbio QuPID Stanbio QuPID PLUS Stanbio True 20 Plus Sure-Vue Sure-Vue (Serum/Urine) Sure-Vue STAT (Serum/Urine) Technologist Choice (serum/urine) Other and Methods with <10 responses
4 Specific Gravity Method/Instrument No. Labs Mean S.D. C.V. ARKRAY Aution Hybrid ARKRAY Aution MAX 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 Mass Gravity Meter ARKRAY Aution MAX Refractometer ARKRAY Aution MAX Eiken US-3100R/3100Rplus Visual Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys Roche Urisys Visual Roche cobas u Pack Cassette Roche cobas u Roche Urisys Siemens Clinitek Atlas Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus Siemens Clinitek Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Method/Instrument No. Labs Median Low High Greater-Than Values Siemens Clinitek Atlas Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus Siemens Clinitek 10 or Siemens Clinitek Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual
5 ph, Urine Method/Instrument ARKRAY Aution Hybrid ARKRAY Aution JET ARKRAY Aution MAX BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer Eiken Uropaper Eiken US-3100R/3100Rplus * Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys Roche Urisys Visual** Roche cobas u Pack Cassette* Roche cobas u * Roche Urisys Siemens Clinitek Atlas Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus Siemens Clinitek 10 or Siemens Clinitek Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Sysmex Reagent Strips Sysmex UX * Roche ph Instrumentation Users: Results should be reported in whole numbers from 5.0 to 9.0, with the exception of 6.5. ** Roche ph Visual Users: Results should be reported in whole numbers, 0.5 increments are not allowed. 4
6 Protein Qualitative, Method 1 Method/Instrument Trace ARKRAY Aution Hybrid ARKRAY Aution MAX BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer Eiken Uropaper Eiken US-3100R/3100Rplus Roche Chemstrip Criterion/II Roche cobas u411, Urisys Roche Urisys Visual Roche cobas u Pack Cassette Roche cobas u Roche Urisys Siemens Clinitek Atlas Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus Siemens Clinitek 10 or Siemens Clinitek Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual
7 Protein Qualitative, Method 2 Protein, Method 2 reporting options in SI units Conventional () SI (g/l) Roche Users only >600 or >1000 >6.0 or >1000 Method/Instrument (Roche only)* >600 or 1000 ARKRAY Aution Hybrid ARKRAY Aution JET ARKRAY Aution MAX Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys Roche Urisys Visual Roche Urisys Siemens Clinitek Atlas** Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus Siemens Clinitek 10 or Siemens Clinitek Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual * Not appropriate for Roche Urisys 1100 users. ** Clinitek Atlas users: for 300 values report as
8 Glucose, Method 1 Method/Instrument Trace ARKRAY Aution Hybrid ARKRAY Aution MAX BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer Eiken Uropaper Eiken US-3100R/3100Rplus Roche Chemstrip Criterion/II Roche cobas u411, Urisys Roche Urisys Visual Roche cobas u Pack Cassette Roche cobas u Roche Urisys Siemens Clinitek Atlas Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus Siemens Clinitek 10 or Siemens Clinitek Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual
9 Glucose, Method 2 Glucose, Method 2 reporting options in SI units Conventional () SI (mmol/l) >500 or >1000 or >2000 >28 or >55 or >111 Method/Instrument * >500 or 1000 or 2000 ARKRAY Aution Hybrid ARKRAY Aution JET ARKRAY Aution MAX * Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys Roche Urisys Visual * Roche Urisys Siemens Clinitek Atlas Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus Siemens Clinitek 10 or Siemens Clinitek Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual *Roche Glucose Visual Users: Results may be reported as 500. All other Roche Glucose Method users should NOT report 500. Analyzers are not able to discern results of 500 vs
10 Reducing Substance CM-16 Method ¼% (Trace) ½% ¾%* 1% 2% Bayer Clinitest, 2 Drop* Bayer Clinitest, 5 Drop * Please note ¾% is not an appropriate response for the Bayer Clinitest, 2-drop method. Ketones, Method 1 Method/Instrument Trace Small Moderate Large ARKRAY Aution MAX Visual Siemens Clinitek Atlas Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual
11 Ketones, Method 2 Method/Instrument Trace ARKRAY Aution Hybrid ARKRAY Aution MAX BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer Eiken Uropaper Eiken US-3100R/3100Rplus Roche Chemstrip Criterion/II Roche cobas u411, Urisys Roche Urisys Visual Roche cobas u Pack Cassette Roche cobas u Roche Urisys Siemens Clinitek Atlas Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus Siemens Clinitek 10 or Siemens Clinitek Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual
12 Ketones, Method 3 Ketones, Method 3 reporting options in SI units Conventional () SI (mmol/l) >150 >15.0 Method/Instrument * 150 ARKRAY Aution Hybrid ARKRAY Aution JET ARKRAY Aution MAX * Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys Roche Urisys * Roche Urisys Siemens Clinitek Atlas Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus Siemens Clinitek 10 or Siemens Clinitek Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual * Roche Urinalysis instruments should not report Analyzers are not able to discern ketones between 60 and
13 Bilirubin, Method 1 Method/Instrument Trace/Small Positive/Moderate Large ARKRAY Aution Hybrid ARKRAY Aution MAX Roche cobas u411, Urisys Visual Roche Urisys Siemens Clinitek Atlas Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus Siemens Ictotest Visual Siemens Clinitek 10 or Siemens Clinitek Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual Bilirubin, Method 2 Method/Instrument Trace ARKRAY Aution Hybrid ARKRAY Aution MAX BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer Eiken Uropaper Eiken US-3100R/3100Rplus Roche Chemstrip Criterion/II Roche cobas u411, Urisys Roche Urisys Visual Roche cobas u Pack Cassette Roche cobas u Roche Urisys Siemens Clinitek Atlas
14 Bilirubin, Method 2 (cont ) Method/Instrument Trace Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus Siemens Clinitek 10 or Siemens Clinitek Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual Sysmex Reagent Strips Sysmex UX Bilirubin, Method 3 Method/Instrument >10.0 ARKRAY Aution Hybrid ARKRAY Aution JET ARKRAY Aution MAX Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys Roche Urisys Roche Urisys Blood or Hemoglobin, Method 1 Method/Instrument Trace/Small Positive/Moderate Marked Positive/Large ARKRAY Aution Hybrid ARKRAY Aution MAX Roche cobas u411, Urisys Visual Roche Urisys Siemens Clinitek Atlas Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus
15 Blood or Hemoglobin, Method 1 (cont ) Method/Instrument Trace/Small Marked Positive/Moderate Positive/Large Siemens Clinitek 10 or Siemens Clinitek Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual Blood or Hemoglobin, Method 2 Method/Instrument Trace ARKRAY Aution Hybrid ARKRAY Aution MAX BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer Eiken Uropaper Eiken US-3100R/3100Rplus Roche Chemstrip Criterion/II Roche cobas u411, Urisys Roche Urisys Visual Roche cobas u Pack Cassette Roche cobas u Roche Urisys Siemens Clinitek Atlas Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus Siemens Clinitek 10 or Siemens Clinitek Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual
16 Blood or Hemoglobin, Method 3 Method/Instrument 5 25 Ery/µL Ery/µL 250 Ery/µL ARKRAY Aution JET Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys Roche Urisys Visual Roche Urisys Siemens Clinitek 500, Advantus Siemens Clinitek Status
17 Blood or Hemoglobin, Method 4 Method/Instrument ± ARKRAY Aution MAX Leukocyte Esterase, Method 1 Method/Instrument Trace Small Moderate Large ARKRAY Aution Hybrid ARKRAY Aution MAX Roche cobas u411, Urisys Visual Roche Urisys Siemens Clinitek Atlas Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus Siemens Clinitek 10 or Siemens Clinitek Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual
18 Leukocyte Esterase, Method 2 Method/Instrument Trace ARKRAY Aution MAX BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer Eiken Uropaper Eiken US-3100R/3100Rplus Roche Chemstrip Criterion/II Roche cobas u411, Urisys Roche Urisys Visual Roche cobas u Pack Cassette Roche cobas u Roche Urisys Siemens Clinitek Atlas Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus Siemens Clinitek 10 or Siemens Clinitek Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual
19 Leukocyte Esterase, Method 3 Method/Instrument 25 µl 75 or 100 µl 250 or 500 µl ARKRAY Aution Hybrid ARKRAY Aution JET ARKRAY Aution MAX Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys Roche Urisys Roche Urisys Siemens Clinitek Atlas Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus Siemens Clinitek 500, Advantus Siemens Clinitek Status
20 Nitrite Method/Instrument Positive ARKRAY Aution Hybrid - 42 ARKRAY Aution JET - 14 ARKRAY Aution MAX BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer 5 23 Eiken Uropaper Eiken US-3100R/3100Rplus - 29 Roche Chemstrip Criterion/II - 59 Roche Chemstrip Urine Analyzer - 12 Roche cobas u411, Urisys Roche Urisys Visual Roche cobas u Pack Cassette Roche cobas u Roche Urisys Siemens Clinitek Atlas Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus Siemens Clinitek 10 or Siemens Clinitek Siemens Clinitek 500, Advantus Siemens Clinitek Atlas - 15 Siemens Clinitek Status Visual Sysmex Reagent Strips Sysmex UX
21 Urobilinogen, Method 1 Method/Instrument ARKRAY Aution Hybrid ARKRAY Aution MAX BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer Eiken Uropaper Eiken US-3100R/3100Rplus Roche cobas u411, Urisys Roche Urisys Visual Roche cobas u Pack Cassette Roche cobas u Roche Urisys Siemens Clinitek 500, Advantus Siemens Clinitek Status Visual
22 Urobilinogen, Method 2 Method/Instrument or or <3.2 µmol/l 1.0 or <2.0 or 16 µmol/l or <35** µmol/l 2.0/3.0 or 34 or 35 or <70 µmol/l 4.0 or 4.0/6.0 or 70 or <140 µmol/l 8.0 or 12.0 or 140 or 200 µmol/l ARKRAY Aution Hybrid ARKRAY Aution JET ARKRAY Aution MAX BioSys/Consult Diag/PSS Select/YD Diag Reagent Strips BioSys/Consult Diag/PSS Select/YD Diag Urine Analyzer Roche Chemstrip Criterion/II Roche Chemstrip Urine Analyzer Roche cobas u411, Urisys Roche Urisys Visual Roche cobas u Pack Cassette Roche cobas u Roche Urisys Siemens Clinitek Atlas Siemens Clinitek Novus/Pro Cassette Siemens Clinitek Novus Siemens Clinitek 10 or Siemens Clinitek Siemens Clinitek 500, Advantus Siemens Clinitek Atlas Siemens Clinitek Status Visual **Note: <35 µmol/l for ARKRAY Aution MAX users only. 21
23 NOTES
24 NOTES
25 NOTES
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