SARS-COV-2-IGG REAGENT KIT

Report

Report Number: 3008344661-2021-00043
Event Type: Malfunction
Date Received: February 13, 2021
Date of Event: January 19, 2021
Report Date: June 10, 2021
Manufacturer: ABBOTT IRELAND
Product Code: QKO
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

PATIENT IDENTIFIER: (B)(6). PATIENT INFORMATION: NO FURTHER PATIENT INFORMATION WAS PROVIDED BY THE CUSTOMER. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 6R86-22 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 6R86-20/30.

Additional Manufacturer Narrative · 1

(B)(4). WAS THIS DEVICE SERVICED BY A THIRD PARTY? NO. THE COMPLAINT INVESTIGATION FOR FALSE NEGATIVE SARS-COV-2 IGG RESULTS INCLUDED A SEARCH FOR SIMILAR COMPLAINTS, AND THE REVIEW OF COMPLAINT TEXT, TRENDING DATA, LABELING, SCIENTIFIC LITERATURE AND DEVICE HISTORY RECORDS. RETURN TESTING WAS NOT COMPLETED AS RETURNS WERE NOT AVAILABLE. IN-HOUSE SENSITIVITY AND SPECIFICITY TESTING FOR REAGENT LOT 20224FN00 WAS COMPLETED USING A RETAINED SAMPLE OF THE COMPLAINT LOT STORED AT THE RECOMMENDED STORAGE CONDITION. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET INDICATING THAT THE LOT IS PERFORMING ACCEPTABLY. DEVICE HISTORY RECORD REVIEW ON LOT 20224FN00 DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, OR DEVIATIONS ASSOCIATED WITH THE COMPLAINT ISSUE. LABELING WAS REVIEWED WHICH ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. THE CUSTOMER OBSERVED FALSE NEGATIVE ARCHITECT SARS-COV2 IGG RESULTS FOR MULTIPLE PATIENTS WITH KNOWN POSITIVE HISTORY OF COVID. THE PATIENTS TESTED POSITIVE ON THE ROCHE & DIASORIN LIAISON PLATFORMS. A DIRECT COMPARISON SHOULD NOT BE MADE BETWEEN THE ARCHITECT SARS-COV-2 IGG ASSAY AND THE DIASORIN ASSAY. THE ARCHITECT SARS-COV-2 IGG IS DESIGNED TO DETECT IMMUNOGLOBULIN CLASS G (IGG) ANTIBODIES TO THE NUCLEOCAPSID PROTEIN OF SARS-COV-2 WHEREAS THE DIASORIN ASSAY IS DESIGNED TO DETECT ANTIBODIES AGAINST THE S1/S2 ANTIGENS OF SARS-COV-2. AS PART OF EVALUATING THE CONSISTENCY OF SARS-COV-2 IGG LOTS, ABBOTT HAS CONDUCTED COMPARISON STUDIES USING A THIRD PARTY MANUFACTURED SAMPLE SET (SERACARE SARS-COV-2 PERFORMANCE PANEL). THIS PROVIDED A BASIS FOR COMPARISON WITH THE ROCHE COBAS ANTI-SARS-COV-2 ASSAY, ANOTHER NUCLEOCAPSID BASED TEST CAPABLE OF DETECTING IGG (AS WELL AS POTENTIALLY IGM AND IGA). TESTING WAS PERFORMED USING FIVE DIFFERENT ABBOTT LOTS WITH COMPARATIVE RESULTS SHOWING GOOD LOT-TO-LOT CONSISTENCY, WITH THE ABBOTT IGG ASSAY CORRECTLY IDENTIFYING 10 OF 10 POSITIVE PANEL MEMBERS. THE NEGATIVE PANEL MEMBER TESTED AS NEGATIVE ON ALL ABBOTT LOTS. IN COMPARISON, THE ROCHE ASSAY DETECTED 9 OF 10 POSITIVE PANEL MEMBERS (ROCHE TESTING PERFORMED BY SERACARE). PER THE PRODUCT LABELING THE ASSAY SENSITIVITY WITHIN THE 95% CONFIDENCE LEVEL IS 95.89%- 100.00%. NEGATIVE RESULTS DO NOT RULE OUT SARS-COV-2 INFECTION, PARTICULARLY IN THOSE WHO HAVE BEEN IN CONTACT WITH THE VIRUS. FOLLOW-UP TESTING WITH A MOLECULAR DIAGNOSTIC SHOULD BE CONSIDERED TO RULE OUT INFECTION IN THESE INDIVIDUALS. PATIENTS HAVE DIFFERENT IMMUNE RESPONSES AND THE INSERT STATES THAT IMMUNOCOMPROMISED PATIENTS WHO HAVE COVID-19 MAY HAVE A DELAYED ANTIBODY RESPONSE AND PRODUCE LEVELS OF ANTIBODY WHICH MAY NOT BE DETECTED AS POSITIVE BY THE ASSAY. IN THIS CASE, NO SPECIFIC DATA WAS PROVIDED FOR THE PATIENTS. RESULTS SHOULD BE USED IN CONJUNCTION WITH OTHER DATA; E.G., SYMPTOMS, RESULTS OF OTHER TESTS, AND CLINICAL IMPRESSIONS. RESULTS FROM ANTIBODY TESTING SHOULD NOT BE USED AS THE SOLE BASIS TO DIAGNOSE OR EXCLUDE SARS-COV-2 INFECTION OR TO INFORM INFECTION STATUS. BASED ON CURRENT LITERATURE, LONG, Q-X ET AL, ¿HTTPS://WWW.NATURE.COM/ARTICLES/S41591-020-0897-1¿, IGG LEVELS MAY NOT APPEAR UNTIL 7 TO 10 DAYS AFTER INFECTION. IN ADDITION, EMERGING LITERATURE ON SARS COV-2 SEROLOGY INDICATES THAT ANTIBODY RESPONSES TO THE VIRUS DECLINE OVER TIME. IN SOME CASES, THIS TRANSIENT RESPONSE RESULTS IN THE DECLINE OF BOTH IGG AND NEUTRALIZING ANTIBODY TITERS. IT REMAINS UNKNOWN FOR HOW LONG ANTIBODIES PERSIST FOLLOWING INFECTION AND IF THE PRESENCE OF ANTIBODIES IS INDICATIVE OF PROTECTIVE IMMUNITY, SEOW ET AL, ¿HTTPS://DOI.ORG/10.1101/2020.07.09.20148429¿, AND OU ET AL, ¿HTTPS://DOI.ORG/10.1101/2020.05.22.20102525¿. THE STUDY, QUAN-XIN LONG ET AL, ¿CLINICAL AND IMMUNOLOGICAL ASSESSMENT OF ASYMPTOMATIC SARS-COV-2 INFECTIONS¿, NATURE MEDICINE, OBSERVED THAT IGG LEVELS AND NEUTRALIZING ANTIBODIES IN A HIGH PROPORTION OF INDIVIDUALS WHO RECOVERED FROM SARS-COV-2 INFECTION START TO DECREASE WITHIN 2¿3 MONTHS AFTER INFECTION. TO ASSESS THE CLINICAL PERFORMANCE OF THE ASSAY, A STUDY WAS PERFORMED USING 122 SERUM AND PLASMA SPECIMENS COLLECTED AT DIFFERENT TIMES FROM 31 SUBJECTS WHO TESTED POSITIVE FOR SARS-COV-2 BY A POLYMERASE CHAIN REACTION (PCR) METHOD AND WHO ALSO PRESENTED WITH COVID-19 SYMPTOMS. THE POSITIVE PERCENT AGREEMENT (PPA) AT >/=14 DAYS POST-SYMPTOM ONSET IS 100.00% (95% CI: 95.89, 100.00). FIVE SPECIMENS FROM 1 IMMUNOCOMPROMISED PATIENT WERE EXCLUDED FROM THE STUDY. WHEN THE RESULTS FROM THESE SPECIMENS WERE INCLUDED, THE PPA AT >/=14 DAYS POST-SYMPTOM ONSET WAS 96.77% (95% CI: 90.86, 99.33). THIS STUDY WAS BASED ON A HOSPITALIZED/SYMPTOMATIC POPULATION. DIFFERENCES IN ANTIBODY RESPONSES BETWEEN POPULATIONS, BASED ON MORE SEVERE VERSUS LESS SEVERE ILLNESS, ARE CONSISTENT WITH PUBLISHED REPORTS, ZHAO J ET AL. 2020, "ANTIBODY RESPONSES TO SARS-COV-2 IN PATIENTS OF NOVEL CORONAVIRUS DISEASE 2019¿, MEDRXIV. ADDITIONALLY, REVIEW OF THE MANUSCRIPT, BRYAN ET AL. 2020, ¿PERFORMANCE CHARACTERISTICS OF THE ABBOTT ARCHITECT SARS-COV-2 IGG ASSAY AND SEROPREVALENCE IN BOISE, IDAHO¿, J. CLIN. MICROBIOL, DOI: 10.1128/JCM.00941-20., SHOWED SENSITIVITY DATA CONSISTENT WITH PRODUCT LABELING. 125 PATIENTS WHO TESTED RT-PCR POSITIVE FOR SARS COV-2 FOR WHICH 689 EXCESS SERUM SPECIMENS WERE AVAILABLE WAS TESTED AND IT WAS FOUND THAT SENSITIVITY REACHED 100% AT DAY 17 AFTER SYMPTOM ONSET AND DAY 13 AFTER PCR POSITIVITY. ABBOTT HAS UPDATED THE SARS-COV-2 IGG ASSAY FILE TO INCLUDE AN EDITABLE GRAYZONE. THIS NEW GRAYZONE WOULD BE APPLICABLE FOR THOSE PATIENTS WHOSE IGG LEVELS MAY BE RISING, I.E., DURING SEROCONVERSION, OR MAY BE DECLINING, I.E., DURING SEROREVERSION, WITH LEVELS BELOW THE CUTOFF. BASED ON THE INVESTIGATION ARCHITECT SARS-COV-2 IGG REAGENT LOT 20224FN00 IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT SARS-COV-2 IGG REAGENT WAS IDENTIFIED.

Additional Manufacturer Narrative · 1

THIS FOLLOW UP IS SUBMITTED WITH DATA THAT HAD PREVIOUSLY BEEN PROVIDED. THERE IS NO CHANGE TO THE CONTENT OF THE DATA.

Description of Event or Problem · 1

THE CUSTOMER OBSERVED FALSE NEGATIVE ARCHITECT SARS-COV2 IGG RESULTS FOR MULTIPLE PATIENTS WITH A KNOW POSITIVE HISTORY OF COVID. THE FOLLOWING DATA WAS PROVIDED: (REFERENCE RANGE: >/= 1.40 INDEX = POSITIVE): SID (B)(6), INITIAL RESULT = 0.19 INDEX, ROCHE TOTAL = 3.24, LIAISON IGG = 21.6, PCR = NOT DETECTED ON (B)(6) 2021. SID (B)(6), INITIAL RESULT = 0.13 INDEX, ROCHE TOTAL = 2.36, LIAISON IGG = 96.8. SID (B)(6), INITIAL RESULT = 0.45 INDEX, ROCHE TOTAL = 5.86, LIAISON IGG = 101. SID (B)(6), INITIAL RESULT = 0.42 INDEX, ROCHE TOTAL = 13.4, LIAISON IGG = 107. SID (B)(6), INITIAL RESULT = 1.09 INDEX, ROCHE TOTAL = 38.2, LIAISON IGG = 37.2, PCR = NOT DETECTED ON (B)(6) 2021. SID (B)(6), INITIAL RESULT = 0.13 INDEX, ROCHE TOTAL = 1.12, LIAISON IGG = 18.0. SID (B)(6), INITIAL RESULT = 0.36 INDEX, ROCHE TOTAL = 14.5, LIAISON IGG = 83.8. SID (B)(6), INITIAL RESULT = 0.62 INDEX, ROCHE TOTAL = 11.6, LIAISON IGG = 44.0. SID (B)(6), INITIAL RESULT = 1.27 INDEX, ROCHE TOTAL = 1.91, LIAISON IGG = 24.8, PCR = DETECTED ON (B)(6) 2021, PCR = NOT DETECTED ON (B)(6) 2021. SID (B)(6), INITIAL RESULT = 0.85 INDEX, ROCHE TOTAL = 15.6, LIAISON IGG = 16.7. SID (B)(6), INITIAL RESULT = 0.65 INDEX, ROCHE TOTAL = 34.8, LIAISON IGG = 24.9. SID (B)(6), INITIAL RESULT = 0.30 INDEX, ROCHE TOTAL = 12.6, LIAISON IGG = 48.1. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
222668	SARS-COV-2-IGG REAGENT KIT	REAGENT, CORONAVIRUS SEROLOGICAL	QKO	ABBOTT IRELAND		20224FN00

Patients

Seq	Age	Sex	Outcome	Treatment
1