Appendix 10: Example of Analytical Specificity Experiment Results

Analytical Specificity

Assay: Glucose Units of Measurement: mg/dL

Method: ChemSmar 2000 Undiluted Concentration: 1000 mg/dL

Diluent: Normal Saline Resulting Concentration: 500 mg/dL

Interferent: Hemoglobin

Experimental Results
Specimen Specimen PID Volume Volume Result Result Average Specimen Volume Volume Result Result Average
1 PID 1 50 uL 50 uL 98 102 100 PID 1 50 uL 50 uL 110 112 111
2 PID 2 50 uL 50 uL 93 95 94 PID 2 50 uL 50 uL 106 108 107
3 PID 3 50 uL 50 uL 80 84 82 PID 3 50 uL 50 uL 94 98 96
4 PID 4 50 uL 50 uL 98 102 100 PID 4 50 uL 50 uL 110 112 111
5 PID 5 50 uL 50 uL 93 95 94 PID 5 50 uL 50 uL 106 108 107
6 PID 6 50 uL 50 uL 80 84 82 PID 6 50 uL 50 uL 94 98 96
7 PID 7 50 uL 50 uL 98 102 100 PID 7 50 uL 50 uL 110 112 111
8 PID 8 50 uL 50 uL 93 95 94 PID 8 50 uL 50 uL 106 108 107
9 PID 9 50 uL 50 uL 80 84 82 PID 9 50 uL 50 uL 94 98 96
10 PID 10 50 uL 50 uL 98 102 100 PID 10 50 uL 50 uL 110 112 111
Differences Between Diluent and Interferent
Specimen Specimen PID Difference
1 PID 1 11 Average Interference: 12.5 mg/dL
2 PID 2 13 Upper Reference Limit: 130
3 PID 3 14 Allowable Systematic Error (%): 10
4 PID 4 11 Allowable Error at Upper Reference 13
5 PID 5 13 Pass / Fail: Pass
6 PID 6 14 Approval:
7 PID 7 11 Date:
8 PID 8 13
9 PID 9 14
10 PID 10 11
Analyst: Velma Jones
Date: 4-Apr-06

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