inforMED
InjuryLIO

ORAQUICK ADVANCE RAPID HIV-1/2 ANTIBODY TEST

Received Jan 8, 2006 · Event occurred Dec 15, 2004

Report MW1037678 · MDR key 664005

Device

Generic name

Oraquick Advence Rapid Hiv-1/2 Antibody Test

Model number

*

Catalog number

*

Lot number

*

Product problems

  • False Positive Result

Patient

29 YR

  • Other (for use when an appropriate patient code cannot be identified)

Narrative

Description of Event or Problem

RPTR TESTED FALSE POSITIVE OVER A YEAR AGO. DESPITE BEING VERY ILL, THE TESTING COUNSELOR PUT THEM AT EASE. THE ORAL SWAB TEST WAS, AS ADVERTISED, QUITE PAINLESS. WHAT FOLLOWED, HOWEVER, WAS NOT. TWO WEEKS LATER RPTR WAS TOLD THEY HAD CONTRACTED HIV. RPTR GAVE FIRST NAMES AND PHONE NUMBERS FOR SEVERAL SEXUAL CONTACTS TO THE STATE'S PUBLIC HEALTH OFFICE FOR THE PURPOSES OF PARTNER NOTIFICATION, AND TO THIS DAY HAS NO IDEA WHAT HAS COME OF THAT VERY SENSITIVE INFO. RPTR QUALIFIED FOR RYAN WHITE ACT FUNDS. THE NEXT DAY BLOOD WAS DRAWN AT THE CLINIC AND RPTR NEARLY FAINTED. RPTR ONLY "CAME TO" BECAUSE IF THEY WENT DOWN, THEY BELIEVED, THEY MIGHT NEVER GET BACK UP. RPTR DIDN'T KNOW HOW FAR THE DISEASE HAD PROGRESSED; RPTR ONLY KNEW THAT THEY WERE VERY SICK. RPTR TOLD NO ONE THAT THEY WERE HIV +, AND DID NOT HAVE TO DEAL WITH THEIR REACTIONS. RPTR'S EIA WAS REACTIVE; WEBSTER BLOT WAS NONREACTIVE. RPTR STILL NEEDED TO RETRIEVE RESULTS FROM BLOOD WORK, BUT THEY HAD ALREADY TALKED WITH THE CLINIC AND THERE WERE NO TRACES OF HIV ANTIBODIES IN RPTR'S BLOOD. RPTR STILL COULDN'T BELIEVE IT, EVEN WHEN THEY WENT TO THE CLINIC THE NEXT DAY TO FIND T-CELLS COUNTING IN AT A HEALTHY 1052. RPTR "KNEW" THEY HAD HIV; BEING TOLD OTHERWISE DRAINED THEM EMOTIONALLY. THE EARTH ITSELF FELL OUT FROM UNDERNEATH THEM. NOTHING SEEMED REAL. IMPERFECT AS THEY ARE, RPTR IS GLAD THAT ORAL SWAB TESTS FOR HIV EXIST. RPTR MIGHT NEVER HAVE TESTED AT ALL, IF ALL TESTING INVOLVED DRAWING BLOOD. - HOWEVER: THEY MUST BE PROFESSIONALLY ADMINISTERED IN CAREFULLY CONTROLLED CLINICAL SETTINGS. ANY PERSON TESTING POSITIVE -- FALSE OR TRUE -- NEEDS SUPPORT IMMEDIATELY ACCESSIBLE WHEN HEARING THEIR RESULTS. ANY PERSON WHO WILL ONLY TEST FOR HIV AT HOME IS DANGEROUSLY ISOLATED TO BEGIN WITH. RPTR WAS NOT ALONE. WAS EXTREMELY LUCKY. IT WAS STILL HARD. IN THE INTERESTS OF PUBLIC HEALTH AND SAFETY, RPTR FEELS THE FDA SHOULD DENY ORASURE TECHNOLOGIES' REQUEST, BECAUSE EXCEPTIONALLY HIGH PERCENTAGES OF FALSE POSITIVES RESULTING FROM USE OF THE ORAQUICK TEST IN CONTROLLED CLINICAL SETTINGS MAKE IT WHOLLY UNSUITABLE FOR HOME USE.