inforMED
InjuryPGI

QUEST INHIBITION ASSAY CONFIRMATORY HSV TEST

Received Dec 16, 2025 · Event occurred Sep 20, 2025

Report MW5180666 · MDR key 23828033

Device

Generic name

Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutane

Manufacturer

Quest Diagnostics

Product problems

  • False Positive Result
  • False Positive Result

Patient

32 YR · Male

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

ADDITIONAL INFORMATION RECEIVED ON 04/23/2026 FOR MW5180666 TO UPDATE PROCODE TO PGI.

Description of Event or Problem

PATIENT HAD A FALSE POSITIVE HSV-2 TEST RESULT. PATIENT TESTED POSITIVE FOR HSV-2 ON A DIASORIN LIAISON XL HSV-2 IGG TEST AT (B)(6). PATIENT ALSO TESTED POSITIVE ON QUEST INHIBITION ASSAY. PATIENT RECEIVED A CONFIRMATORY TEST VIA (B)(6) BLOT WHICH WAS NEGATIVE. PT CODE: 4582. DEVICE CODE: 1227. REF REPORT: MW5180665.