Description of Event or Problem · 1
UNABLE TO VERIFY REPORTABLE RANGE DURING LABORATORY PERFORMANCE VERIFICATION. UNABLE TO VERIFY LIMIT OF DETECTION AS STATED IN PRODUCT INSERT. CONTACTED MANUFACTURER WHO STATES THAT DEVICE DOES NOT USE LIMIT OF DETECTION AS INDICATED IN THE PRODUCT INSERT FOR REPORTING POSITIVE VS. NEGATIVE FOR TEST TARGET. THIS PRACTICE CONTRADICTS WITH CLIA REGULATORY STANDARDS FOR REPORTING POSITIVE RESULTS USING ESTABLISHED LIMIT OF DETECTION ((B)(4), REFERENCE ON FDA SITE AS GUIDANCE DOCUMENT FOR PRODUCT DEVELOPMENT). CLINICAL REPORTING SHOULD BE SAFE GUARDED BY HAVING MINIMUM OF 95 PERCENT CONFIDENCE FOR POSITIVE RESULTS AND/OR ACCOMPANIED BY THE DISCLAIMER FOR LIMIT OF DETECTION FOR THE TEST (REFERENCE ATTACHED). CONCLUSIONS: TEST DOES NOT PERFORM AS EXPECTED IF HAVING LOD 91 IU/ML. MANUFACTURER'S PACKAGE INSERT SPECIFIES LIMIT OF DETECTION AS 91 IU/ML THUS EXPECTED PERFORMANCE FOR VALUES BELOW 91 IU/ML WOULD BE TO OBSERVE REPORTABLE RESULT AS TARGET NOT DETECTED OR EMPLOYMENT OF THE DISCLAIMER THAT SPECIFIES THAT RESULTS BELOW THE LOD ARE REPORTED AS POSITIVE AND SHOULD BE TAKEN WITH DISCRETION SINCE THEY ARE LESS THAN 95 PERCENT CONFIDENT. LIMIT OF QUANTITATION (LOQ) IS DIFFERENT PARAMETER OF THE TEST AND ONLY VALUES BELOW LOQ BUT ABOVE LOD SHOULD BE REPORTED AS POSITIVELY DETECTED. DURING PERFORMANCE VERIFICATION WE OBSERVED 75 SAMPLES WITH EXPECTED RESULTS "TARGET NOT DETECTED" REPORTED AS "POSITIVE." WE BELIEVE THAT DEVICE POSSESSES SERIOUS RISK OF REPORTING FALSE-POSITIVE RESULT WITHOUT ANY JUSTIFIABLE CLINICAL SIGNIFICANCE THUS PROJECTING UNNECESSARY FINANCIAL AND HEALTH BURDEN FOR PATIENTS TARGETED FOR TREATMENT OF OMV VIREMIA BASED ON "DETECTED"/ "NOT DETECTED" ALGORITHM.