The Aridia HSV1/HSV2/T. pallidum Real-Time PCR Test is based on the real-time amplification and detection of HSV1, HSV2, and T. pallidum in a one-step format.
The test is designed for specific and qualitative detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV1 and HSV2) and/or Treponema pallidum in clinical respiratory specimens as an aid in the diagnosis of HSV1, HSV2, and/or T. pallidum infections alongside all available clinical and epidemiological data, patient history, and other laboratory test outcomes. The product is intended for use by professionals specifically trained in nucleic acid amplification techniques and in vitro diagnostic procedures.
Recommended for use:
Any person exhibiting genital lesions or ulcers, which generally appear several weeks after sexual transmission and infection.
HSV1, HSV2, and T. pallidum DNA is detectable in clinical specimens obtained from swabs of genital lesions. A positive PCR test is confirmatory of infection. A negative PCR test does not exclude infection and should be followed up with additional serological diagnostic testing. All test results should be evaluated by a health care professional in the context of clinical symptoms, epidemiological information, patient history, and other diagnostic test results.
Limit of Detection: ≥50 HSV1 copies are detected as positive ≥95% of the time and reactions containing ≥10 HSV1 copies are detected as positive ≥75% of the time. PCR reactions containing ≥10 HSV2 copies are detected as positive ≥95% of the time. PCR reactions containing ≥10 T. pallidum copies are detected as positive ≥95% of the time
Cross-Reactivity: no cross-reactivity with many common pathogens causing sexually transmitted diseases (see details in package insert)