Analytical Performance Evaluation of Aptima Herpes Simplex Virus 1 and 2 Assay Using Hologic Panther Instrument.

Abstract:

OBJECTIVE:Herpes simplex viruses 1 and 2 (HSV-1 and HSV-2) are responsible for a variety of human diseases. Therefore, rapid detection of these viruses in clinical laboratory is important. Recently Aptima Herpes Simplex 1 and 2 assay has been approved by the FDA. We evaluated analytical performance of this assay by comparing results obtained by analysis of cultures. MATERIALS AND METHODS:Aptima Herpes Simplex assay is a nucleic acid amplification test that can be fully automated using the Hologic Panther instrument. This is a qualitative test providing either positive or negative result. We analyzed 115 specimens collected from anogenital locations using the new Aptima Herpes Simplex assay and our current tissue culture method. RESULTS:We observed good correlation between results obtained by using Aptima assay and the tissue culture method in 101 specimens but 14 specimens showed discordant results. Further testing in a reference laboratory using PCR (polymerase chain reaction) showed results in agreement with the Aptima assay but not the tissue culture method. The cause of discordance was misidentification of HSV-2 as HSV-1 by the tissue culture method. CONCLUSIONS:Aptima Herpes simplex assay on the Hologic Panther instrument is suitable for rapid detection of herpes simplex virus in clinical laboratory.

journal_name

Ann Clin Lab Sci

authors

Dixon RB,Bonaparte J,Greenwood CJ,Davis M,Dasgupta A

subject

Has Abstract

pub_date

2020-03-01 00:00:00

pages

278-281

issue

2

eissn

0091-7370

issn

1550-8080

pii

50/2/278

journal_volume

50

pub_type

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