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Cumitech 31- Verification and Validation of Procedures in the Clinical Microbiology Laboratory, contains some information that helps answer your question. In general, if you are performing the test exactly following the manufacturer's instructions, you would need a minimum of 20 true positive test results and 50 true negative test results. The comparator (reference test) would generally be a well-performed throat culture. From the results of this testing, you can calculate performance characteristics-sensitivity, specificity, positive and negative predictive value. It is important to appreciate that obtaining 20 positve test results gives a sensitivity with a significant standard deviation but that is about the most testing that most small labs can perform.
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