COBAS MPX TEST, CE-IVD

Additional Manufacturer Narrative

AN INVESTIGATION WAS PERFORMED AND NO KIT ISSUES WERE IDENTIFIED RELATING TO (B)(6) RESULTS. BASED ON THE RESULTS GENERATED FOR THIS DONOR, THE DONOR WAS LIKELY (B)(6) IN (B)(6) WITH A LOW LEVEL (B)(6) INFECTION, WHICH MAY NOT CONSISTENTLY BE DETECTED BY THE COBAS MPX TEST, WHERE SEROLOGY WAS NEGATIVE DUE TO THE LACK OF SEROCONVERSION (WINDOW PERIOD). THE COBAS MPX TEST, CE IVD INSTRUCTIONS FOR USE INDICATES "DETECTION OF HIV-1 GROUP M RNA, HIV-1 GROUP O RNA, HIV-2 RNA, HCV RNA, AND HBV DNA IS DEPENDENT ON THE NUMBER OF VIRUS PARTICLES PRESENT IN THE SAMPLE AND MAY BE AFFECTED BY SAMPLE COLLECTION, STORAGE AND HANDLING, PATIENT FACTORS (I.E., AGE, PRESENCE OF SYMPTOMS), AND/OR STAGE OF INFECTION AND POOL SIZE." THE MATERIAL NUMBER FOR THE COBAS MPX TEST, 480T, US-IVD IS 06998917190. (B)(4).

Description of Event or Problem

A (B)(6) CUSTOMER ALLEGED THE GENERATION OF A (B)(6) SAMPLE TESTED WITH THE COBAS MPX TEST FOR USE ON THE COBAS 6800/8800 SYSTEM ((B)(6) 2018). AS THE RESULT MATCHED (B)(6) SEROLOGY RESULTS (ABBOTT), THE DONATION WAS RELEASED. A NEW SAMPLE COLLECTION WAS TAKEN FROM THIS DONOR IN (B)(6) 2018 AND TESTED IN A POOL OF 1 (PP1) WITH THE COBAS MPX TEST (LOT CURRENTLY UNKNOWN) AS THERE WAS INFORMATION THAT A RECIPIENT OF THE PLASMA SAMPLE FROM (B)(6) 2018 HAD DEVELOPED AN (B)(6) INFECTION. RESULTS OF THE NEW COLLECTION INDICATED THAT THE DONOR SAMPLE WAS (B)(6) WITH LATE CT VALUES. SEROLOGY RESULTS, TESTED WITH ABBOTT, FOR THE NEW DRAW WERE ALSO (B)(6). NO FURTHER INFORMATION ON THE STATUS OF THE RECIPIENT HAS BEEN PROVIDED TO DATE.