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Method:
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Real-Time Polymerase Chain Reaction (PCR)
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Analytical Sensitivity:
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100% (n = 20)
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Analytical Specificity:
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No cross reactivity was observed in samples
spiked with CMV, VZV, normal oral flora, or normal genital flora.
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Limit of Detection:
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7 copies/µL for HSV1 and HSV2
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A negative result indicates no HSV DNA was detected but does not rule out the presence of HSV DNA below the detection limit of the assay and/or presence of inhibitory substances.
Assay methodology is real-time polymerase chain reaction (RT-PCR) performed pursuant to a license agreement with Roche Molecular Systems, Inc.
This test, which uses Analyte Specific Reagents, was developed and its performance characteristics determined by Legacy Laboratory. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This test is used for clinical purposes. It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform high complexity clinical laboratory testing.