Other Parameters

CLIA '88 states that "any other performance characteristic required for test performance" must also be verified or confirmed. Given the generality of this statement, this requirement can be interpreted in a myriad of different ways. Specimen or sample stability is one assay parameter that the laboratory might want to verify. The need for verification of this parameter depends on the location of the testing laboratory with respect to the patients from which the specimens are obtained. For laboratories in the same physical location as the patients, specimen stability might not be a major concern.

However, for central or referral laboratories, optimal specimen storage and transport conditions should be identified to ensure the validity of the assay results with respect to the patient. Simple experiments can be designed to test the length of time that specimens can be stored at various temperatures and still allow for accurate detection of the nucleic acid ana-lyte in these specimens.

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