BIOKIT HSV-2 RAPID TEST
Received Feb 10, 2020
Report MW5092892 · MDR key 9693750
Device
Generic name
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-specific
Manufacturer
Biokit, SaModel number
3000 28001Lot number
B31915
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
TWENTY-ONE BLOOD SAMPLES THAT WERE (B)(6) FOR (B)(6) ON THE DIASORIN LIAISON HSV TEST WERE SUBMITTED TO (B)(6) FOR BIO KIT TEST. SIX OF THE SAMPLES WERE BIOKIT (B)(6): THE 6 BIOKIT (B)(6) SAMPLES WERE SENT FOR WESTERN BLOT TEST 4 WERE WB (B)(6) FOR (B)(6). I WAS WB (B)(6) FOR (B)(6) WAS WB INDETERMINATE FOR (B)(6). (B)(6) RATE FOR BIOKIT COMPARED TO WESTERN BLOT (RUN AT UNIVERSITY OF (B)(6)) WAS 66%. THE 6 BIOKIT SAMPLES WERE RUN AT (B)(6). DIASORIN LIAISON IS AN FDA-CLEARED SCREENING TEST FOR (B)(6) BY IMMUNOASSAY. WESTERN BLOT IS THE GOLD STANDARD FOR CONFIRMATION AND WAS RUN AT THE UNIVERSITY OF (B)(6) UROLOGY LAB.