HSV 1 and 2 (Aptima® HSV 1 & 2 Assay) -IVD
TEST: CPT: 87529 x2
Causes for Rejection
Expected Turnaround Time 1-4 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the report is sent to the ordering provider. Additional time should be allowed for confirmatory, or reflex tests.
SPECIMEN COLLECTION GUIDE
Swab of Anogenital lesions collected with Aptima Multitest
Care provider specimen: Lesion/vesicle swab: Unroof or scrape the lesion with an Aptima® swab. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube. Tightly screw on the cap.
Store and transport specimens at room temperature (15 to 30°C). DO NOT freeze.
Specimen with incorrect patient identification; unlabeled specimen; inappropriate specimen transport conditions; specimens received after prolonged delay from time of pickup (usually >72 hours); specimen leaked in transit; specimen in expired transport or incorrect transport device; specimens with inappropriate source for test requested; specimen with fixative or additives; Aptima® swab transport >30 days from collection; Aptima® swab specimens with incorrect specimen volume; Aptima® swab specimen without a swab; any non−Aptima® swab submitted in Aptima® transport device; wooden-shaft swab in transport device; transport device with multiple swabs; female urethral swab; bloody or grossly mucoid specimens; bacterial swabs; specimen in MDL OneSwab®, ProbeTec™ UPT transport; ProbeTec™ Q-swabs; UTM-RT
The Aptima® Herpes Simplex Viruses 1 & 2 assay (Aptima HSV 1 & 2 assay) is an in vitro diagnostic nucleic acid amplification test (NAAT), using real time transcription-mediated amplification (TMA), for the qualitative detection and differentiation of herpes simplex virus type 1 (HSV-1) and type 2 (HSV-2) messenger RNA (mRNA) in clinician-collected swab specimens from anogenital skin lesions. The assay is intended for use with swab specimens placed in Aptima specimen transport medium (STM) or in viral transport media (VTM) that is immediately diluted into STM. The Aptima HSV 1 & 2 assay is intended for use as an aid in the diagnosis of HSV-1 and/or HSV-2 infections in symptomatic male and female patients. The Aptima HSV 1 & 2 assay is indicated for use on the Panther ® system.
Reliable results are dependent on adequate specimen collection, transport, storage, and processing.
A negative Aptima HSV 1 & 2 assay result does not preclude a possible infection because results are dependent on adequate specimen collection. The assay results may be affected by improper specimen collection, technical error, clinical stage of the lesion sampled, or target levels below the assay limit of detection
The Aptima HSV 1 & 2 assay is used with swab specimens collected from male and female anogenital skin lesions and stored in the Aptima specimen transport media (STM) and viral transport media (VTM). Performance characteristics of other specimen types have not been established.
The Aptima HSV 1 & 2 assay has not been validated for use with patient-collected lesion swab specimens.
Nucleic acid amplification (NAAT)
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