2008 CM-A PARTICIPANT SUMMARY
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1 2008 CM-A PARTICIPANT SUMMARY Evaluation Criteria QUALITATIVE 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. 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 Occult Blood Protein, Confirmatory Urine hcg Evaluation Criteria Educational Educational QUANTITATIVE Analyte Target Value Evaluation Criteria Gastric ph Peer Group Mean ± 3 SD Osmolality Peer Group Mean ± 3 SD Specific Gravity Peer Group Mean ± 2 SD or 0.010, whichever is greater Low 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. PHOTOMICROGRAPHS/PHOTOGRAPHS Photomicrographs/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 response. 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 56. 1
2 Urine hcg Evaluation is based on sensitivity of the kit and participant consensus by method. The hcg level was intended to be positive. Manufacturer's Stated Sensitivity Level Method miu/ml Negative Positive ACON One Step (s/u) Beckman Coulter ICON II (serum/urine) Beckman Coulter ICON Beckman Coulter ICON Cardinal SP Cassette Cardinal SP Combo Genzyme Diagnostics Contrast Genzyme OSOM (w) Genzyme OSOM Combo LifeSign Status (serum/urine) Mainline Confirms hcg (combo) Mainline Confirms hcg (urine) Meridian ImmunoCard STAT Polymedco Poly stat (urine) Polymedco Poly stat Quidel QuickVue Plus One-Step Combo Quidel QuickVue One-Step Combo Quidel QuickVue One-Step Urine Quidel QuickVue Semi-Q Combo Ramco Quik-Trak Combi Test Randox Direct SA Scientific (serum/urine) SA Scientific Ultra Siemens Diag Clinitek Status Signify hcg Urine/Serum Stanbio QuPID Stanbio QuPID Plus Sure-Vue (serum/urine) Sure-Vue (urine only) Sure-Vue STAT (serum/urine) Thermo BioStar Acceava Combo Thermo BioStar Acceava (urine) Wampole Clearview Combo Wampole Clearview hcg II Cassette Other, Methods with <10 participants
3 Specific Gravity Method/Instrument No. Labs Mean S.D. C.V. ARKRAY Aution Sticks ARKRAY/IRIS Aution Jet ARKRAY/IRIS Aution Max Iristrips Iris Model 500 (and earlier) Iris Mass Gravity Meter ARKRAY/IRIS Aution Max Iris Model 500 (and earlier) Refractometer ARKRAY/IRIS Aution Max Roche Urisys Siemens Diag Clinitek Atlas Visual Roche Chemstrip/Combur Roche Chemstrip Roche Chemstrip Criterion/II Roche Chemstrip Super UA Roche Chemstrip Urine Analyzer Roche Urisys Roche Urisys Visual Roche Urisys Cassette Roche Urisys Siemens Diag Clinitek Atlas RGT Siemens Diag Clinitek Atlas Siemens Diag Reagent Strips Siemens Diag Clinitek Atlas Siemens Diag Clinitek 10/ Siemens Diag Clinitek Siemens Diag Clinitek 200/ Siemens Diag Clinitek Siemens Diag Clinitek Status Visual YD Diagnostics UriScan Strips YD Diagnostics UriScan OPT/PRO
4 ph, Urine Method/Instrument 3.5 or less >9.0 ARKRAY Aution Sticks ARKRAY/IRIS Aution Jet ARKRAY/IRIS Aution Max ARKRAY/Thermo PocketChem Iristrips Iris Model 500 (and earlier) Iris ichem Reagent Strips Iris ichem Roche Chemstrip/Combur* Roche Chemstrip Roche Chemstrip Criterion/II Roche Chemstrip Super UA Roche Chemstrip UA Roche Urisys Roche Urisys Visual** Roche Chemstrip LN Roche Chemstrip Criterion/II Roche Urisys Cassette* Roche Urisys Siemens Diag Clinitek Atlas RGT Siemens Diag Clinitek Atlas Siemens Diag Reagent Strip Siemens Diag Clinitek Atlas Siemens Diag Clinitek 10/ Siemens Diag Clinitek Siemens Diag Clinitek 200/ Siemens Diag Clinitek Siemens Diag Clinitek Status Visual YD Diagnostics UriScan Strips YD Diagnostics UriScan PT/PRO * 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. 9
5 Protein - Qualitative Method/Instrument Negative Trace (15 ) 30 (1+) 75 (Roche Urisys only) (2+) (3+) >1000 (4+) ARKRAY Aution Sticks ARKRAY/IRIS Aution Jet ARKRAY/IRIS Aution Max ARKRAY/Thermo PocketChem Iristrips Iris Model 500 (and earlier) Iris ichem Reagent Strips Iris ichem Roche Chemstrip/Combur Roche Chemstrip Roche Chemstrip Criterion/II Roche Chemstrip Super UA Roche Chemstrip UA Roche Urisys Roche Urisys Visual Roche Chemstrip LN Roche Chemstrip Criterion/II Roche Urisys Cassette Roche Urisys Siemens Diag Clinitek Atlas RGT Siemens Diag Clinitek Atlas Siemens Diag Reagent Strip Siemens Diag Clinitek Atlas Siemens Diag Clinitek 10/ Siemens Diag Clinitek Siemens Diag Clinitek 200/ Siemens Diag Clinitek Siemens Diag Clinitek Status Visual YD Diagnostics UriScan Strips YD Diagnostics UriScan PT/PRO
6 Specific Gravity Acceptable Criteria = ± 2 SD or 0.010, whichever is greater Your result Mean SD Lower Upper SDI Your Grade Unacceptable CM #DIV/0! CM #DIV/0! ph, Urine Your result Good/Acceptable Responses Your Grade /7.0/7.5/8.0 Acceptable CM-02 CM-03 Urine hcg Your result Intended Response Your Grade Positive Positive Acceptable CM-02 CM-03 Protein, Urine - Qualitative Your result Good/Acceptable Responses Your Grade CM-1 Trace / />1000 Unacceptable CM-2 CM-3
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