VIDAS SARS-COV-2 IGG (9COG) 60T

Report

Report Number: 8020790-2021-00148
Event Type: Malfunction
Date Received: June 24, 2021
Report Date: November 1, 2021
Manufacturer: BIOMERIEUX SA
Product Code: QKO
PMA / PMN Number: UNCLASSIFIED
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: HR
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

AN INTERNAL INVESTIGATION WAS PERFORMED FOLLOWING NOTIFICATION FROM A CUSTOMER IN (B)(6) OF OBTAINING NEGATIVE RESULTS ON SEVERAL PATIENTS¿ SAMPLES WHEN TESTING THEM WITH VIDAS® SARS COV-2 IGG (REF.423834 LOT 1008674550). SAMPLES WERE POSITIVE USING A COMPETITOR METHOD (ROCHE ELECSYS, COBAS INSTRUMENT). SAMPLE ID (B)(6): NEGATIVE WITH VIDAS® COV-2 IGG AND VIDAS® SARS COV-2 IGM AND POSITIVE WITH ROCHE (GLOBAL ANTIBODIES DETECTION). SAMPLE ID (B)(6): NEGATIVE WITH VIDAS® COV-2 IGG AND VIDAS® SARS COV-2 IGM AND POSITIVE WITH ROCHE (GLOBAL ANTIBODIES DETECTION). SAMPLE ID (B)(6): NEGATIVE WITH VIDAS® COV-2 IGG AND VIDAS® SARS COV-2 IGM AND POSITIVE WITH ROCHE (GLOBAL ANTIBODIES DETECTION). SAMPLE ID (B)(6): NEGATIVE WITH VIDAS® COV-2 IGG AND VIDAS® SARS COV-2 IGM AND POSITIVE WITH ROCHE (GLOBAL ANTIBODIES DETECTION). SAMPLE ID (B)(6): NEGATIVE WITH VIDAS® COV-2 IGG AND VIDAS® SARS COV-2 IGM AND POSITIVE WITH ROCHE (GLOBAL ANTIBODIES DETECTION). NO CLINICAL HISTORY AVAILABLE (CONTACT, INFECTION OR VACCINATION). THE CUSTOMER SUBMITTED THE FIVE SAMPLES FOR THE INVESTIGATION. INVESTIGATION: ACCORDING TO QUALITY CONTROL RECORD REVIEW, THERE IS NO ANOMALY HIGHLIGHTED DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES OF THE LOT. CONTROL CHART ANALYSIS WAS CARRIED OUT FOR FIVE INTERNAL SAMPLES WITH (2 WITH A NEGATIVE TARGET AND 3 WITH A POSITIVE TARGET), USING SEVEN (7) BATCHES OF VIDAS SARS COV-2 IGG INCLUDING THE CUSTOMER¿S LOT. ALL THE SAMPLE RESULTS COMPLY WITH THE SPECIFICATIONS, AND THE CUSTOMER¿S LOT WAS CONSISTENT COMPARED TO THE OTHER. TESTING VIDAS® SARS COV-2 IGG, INTERNAL SAMPLES: FOUR INTERNAL SAMPLES (1 NEGATIVE TARGET AND 3 WITH A POSITIVE TARGET) WERE TESTED ON THE FOUR LOTS OF VIDAS® SARS COV-2 IGG, INCLUDING THE CUSTOMER¿S LOT. THE TWO NEGATIVE TARGETS GAVE NEGATIVE RESULTS, AND THE POSITIVE SAMPLES WERE POSITIVE, WITH NO SIGNIFICANT DIFFERENCE IN THE RESULTS OBSERVED BEFORE THE BATCHES RELEASE. PATIENT SAMPLE TESTING: COMPETITOR METHOD TESTING WAS PERFORMED USING EUROIMMUN ANTI SARS COV2 ELISA IGG (DETECTION OF IGG ANTIBODIES AGAINST SPIKE PROTEIN): THREE (3) SAMPLES GAVE A NEGATIVE RESULT ((B)(6)). ONE (1) SAMPLE GAVE AN EQUIVOCAL RESULT (ID (B)(6)). ONE SAMPLE (1) GAVE A POSITIVE RESULT (ID (B)(6)). TEST ON VIDAS SARS COV-2 IGG II. THE FIVE SAMPLES PROVIDED BY THE CUSTOMER WERE TESTED ON VIDAS SARS COV-2 IGG II LOT 1008663570. FOUR (4) SAMPLES GAVE ALSO A NEGATIVE RESULT WITH VIDAS SARS COV-2 IGG II. THE SAMPLE ID (B)(6) GAVE A POSITIVE RESULT (1.17 TV) JUST ABOVE THE POSITIVE THRESHOLD (INDEX=1TV). AS A REMINDER, THIS SAMPLE GAVE A NEGATIVE RESULT WHEN TESTING BY THE CUSTOMER ON VIDAS SARS COV-2 IGG LOT 1008674550 WITH AN INDEX (0.89 TV) JUST BELOW THE POSITIVE THRESHOLD. THE SAMPLES ID (B)(6) AND ID (B)(6) WERE ALSO TESTED WITH AN IN-HOUSE WESTERN BLOT: USING THE SAME MAIN RAW MATERIALS AS THOSE USED IN THE MANUFACTURING OF VIDAS SARS COV-2 IGG ASSAY (RBD ANTIGEN AND CONJUGATE). USING A NUCLEOCAPSID ANTIGEN AND AN EXTERNAL RBD PROTEIN. THE REVELATION WAS PERFORMED USING HUMAN IMMUNOGLOBULINS IGM AND IGG. THE SAMPLES SHOWED TO HAVE MAINLY AN IMMUNE REACTIVITY OF IGG ANTIBODIES AGAINST NUCLEOCAPSID ANTIGEN. REGARDING THE IMMUNE REACTIVITY OF IGG ANTIBODIES AGAINST RBD ANTIGEN, THE INTENSITY IS COMPARABLE (SLIGHTLY LOWER) TO THE REACTIVITY OF AN INTERNAL SAMPLE KNOWN TO GIVE INDEX BELOW THE POSITIVE THRESHOLD (0.97 TV) ON VIDAS SARS COV-2 IGG. CONCLUSION: BASED ON THE INVESTIGATION OUTCOMES, THERE IS NO RECONSIDERATION OF VIDAS SARS COV-2 IGG PERFORMANCES. REGARDING THE SENSITIVITY OF THIS VIDAS ASSAY, PER THE PACKAGE INSERT: ¿THE SENSITIVITY (POSITIVE PERCENT AGREEMENT) EVALUATED IS 96.6% FOR SAMPLES COLLECTED AFTER 16 DAYS AFTER PCR POSITIVE RESULT." SOME DISCREPANCIES CAN BE OBSERVED ESPECIALLY IN CASE OF MILD COVID 19. THE RESULTS ARE IN FAVOR OF A LOW LEVEL OF IGG ANTIBODIES WITH MAINLY ANTIBODIES AGAINST NUCLEOCAPSID ANTIGEN. THE CUSTOMER¿S ISSUE (NAMELY A NEGATIVE INTERPRETATION) WHEN TESTING POSITIVE INTERNAL SAMPLES ON THE LOT 1008674550 OF VIDAS SARS COV-2 IGG WAS NOT REPRODUCED. VIDAS SARS COV-2 IGG LOT 1008674550 DOES NOT SHOW TO HAVE AN EVOLUTION OVER TIME OF THEIR ACTIVITY. THREE PATIENT SAMPLES GAVE A NEGATIVE INTERPRETATION FOR IGG ANTIBODIES ANTI SARS COV-2 USING EUROIMMUN METHOD. ONE (1) SAMPLE WAS INTERPRETED AS EQUIVOCAL (ID (B)(6)) AND THE LAST ONE (ID (B)(6)) GAVE A POSITIVE INTERPRETATION (WITH A VALUE CLOSE TO THE POSITIVE THRESHOLD). THIS SAMPLE GAVE ALSO A WEAK POSITIVE RESULT USING NOVALISA IGG METHOD. FOUR PATIENT SAMPLES OUT OF FIVE GAVE A NEGATIVE RESULTS USING VIDAS SARS COV-2 IGG II REAGENT REF.424114. THE LAST ONE GAVE A POSITIVE ONE WITH AN INDEX JUST ABOVE THE POSITIVE THRESHOLD OF THE METHOD (THIS SAMPLE WAS NEGATIVE AT THE CUSTOMER SITE WITH A NEGATIVE INDEX CLOSE TO THE THRESHOLD OF 1 TV). ACCORDING TO IN-HOUSE WESTERN BLOT METHOD, IT SEEMS THAT: THE SAMPLE ID (B)(6) HAVE MAINLY IGG ANTIBODIES AGAINST NUCLEOCAPSID ANTIGEN AND A LEVEL OF IGG ANTIBODIES AGAINST RBD PROTEIN JUST BELOW THE POSITIVE THRESHOLD OF VIDAS SARS COV-2 IGG METHOD (SIMILAR IMMUNE REACTIVITY AS A SERUM WITH AN INDEX JUST BELOW THE POSITIVE THRESHOLD). ACCORDING TO THE INVESTIGATIONS OUTCOMES, THE DISCREPANT RESULTS BETWEEN METHODS COULD BE LINKED TO THE SAMPLES¿ PROFILE AND ANTIBODY LEVELS CLOSE TO THE THRESHOLD. SARS COV-2 ANTIBODIES METHODS HAVE DIFFERENT FORMAT (GLOBAL DETECTION OF HUMAN IMMUNOGLOBULINS OR SEPARATE DETECTION; DETECTION OF ANTIBODIES AGAINST NUCLEOCAPSID PROTEIN, SPIKE PROTEIN OR RBD ANTIGEN). IT IS MENTIONED IN THE PACKAGE INSERT OF VIDAS SARS COV-2 IGG REF.423834 AT THE SECTION LIMITATIONS OF THE METHOD RESULTS OBTAINED USING SAMPLES FROM SARS-COV-2 INFECTED PATIENTS MUST BE INTERPRETED WITH CAUTION. THE INDIVIDUAL IMMUNE RESPONSE FOLLOWING SARS-COV-2 INFECTION VARIES CONSIDERABLY AND MIGHT GIVE DIFFERENT RESULTS WITH ASSAYS FROM M DIFFERENT MANUFACTURERS. RESULTS OF ASSAYS FROM DIFFERENT MANUFACTURERS SHOULD NOT BE USED INTERCHANGEABLY. ACCORDING TO THE INFORMATION MENTIONED ABOVE, THERE IS NO RECONSIDERATION OF VIDAS SARS COV-2 IGG REF.423834 FOR LOT 1008674550.

Description of Event or Problem · 0

INTENDED USE: VIDAS® SARS-COV-2 IGG (9COG) IS AN AUTOMATED QUALITATIVE ASSAY FOR USE ON THE VIDAS® FAMILY OF INSTRUMENTS, FOR THE DETECTION OF IMMUNOGLOBULIN G (IGG) SPECIFIC FOR SARS-COV-2 IN HUMAN SERUM OR PLASMA (LITHIUM HEPARIN) USING THE ELFA (ENZYME LINKED FLUORESCENT ASSAY) TECHNIQUE. THIS ASSAY IS INTENDED FOR USE AS AN AID TO DETERMINE IF INDIVIDUALS MAY HAVE BEEN EXPOSED AND INFECTED BY THIS VIRUS AND IF THEY HAVE MOUNTED A SPECIFIC ANTI-SARS-COV-2 IGG IMMUNE RESPONSE. INTERPRETATION OF RESULTS ACCORDING TO TEST VALUE (I) IS AS FOLLOWS: INDEX INTERPRETATION: I < 1.00 : NEGATIVE, I = 1.00 : POSITIVE. ISSUE DESCRIPTION: ON (B)(6) 2021, A CUSTOMER FROM (B)(6) REPORTED TO BIOMÉRIEUX THAT THEY OBSERVED DISCREPANT RESULTS (SUSPECTED FALSE NEGATIVE RESULTS) WHEN TESTING 5 PATIENT SAMPLES WITH VIDAS SARS-COV-2 IGG (9COG) 60T (REF. 423834, BATCH 1008674550, EXPIRY DATE 06-APR-2022) COMPARED TO ANOTHER METHOD FROM ROCHE. THE CUSTOMER OBTAINED THE FOLLOWING RESULTS WITH THESE 5 PATIENT SAMPLES: (B)(6). BASED ON THE AVAILABLE INFORMATION AT THE TIME OF THIS ASSESSMENT, NO PATIENT HARM OR INCORRECT TREATMENT DUE TO THE DISCREPANT RESULT WAS REPORTED. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED. NOTE: REFERENCE 423834 IS NOT SOLD OR DISTRIBUTED IN THE UNITED STATES. HOWEVER, U.S-ONLY PRODUCT REFERENCE, 423834-01, HAS THE SAME FORMULATION AND PHYSICAL PROPERTIES AS REFERENCE 423834.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
960148	VIDAS SARS-COV-2 IGG (9COG) 60T	VIDAS SARS-COV-2 IGG (9COG) 60T	QKO	BIOMERIEUX SA		1008674550

Patients

Seq	Age	Sex	Outcome	Treatment
1