BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SARS-COV-2-IGG REAGENT KIT

    MDR report key: 11179958 · Received January 15, 2021

    Report

    Report Number
    3008344661-2021-00014
    Event Type
    Malfunction
    Date Received
    January 15, 2021
    Date of Event
    December 30, 2020
    Report Date
    February 18, 2021
    Manufacturer
    ABBOTT IRELAND
    Product Code
    QKO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 06R87-32 THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 06R87-30.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT INVESTIGATION FOR FALSE NEGATIVE ARCHITECT 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 POSSIBLE AS RETURNS WERE NOT AVAILABLE. CLINICAL SPECIFICITY AND SENSITIVITY TESTING WERE COMPLETED WITH AN IN-HOUSE RETAINED KIT OF REAGENT LOT 20100FN00 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 20100FN00 DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, OR DEVIATIONS. LABELING WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE ISSUE UNDER REVIEW. IN THIS CASE NO SPECIFIC DATA WAS PROVIDED FOR THE PATIENT. A DIRECT COMPARISON SHOULD NOT BE MADE BETWEEN THE ARCHITECT SARS-COV-2 IGG ASSAY AND THE VECTOR BEST SARS-COV-2 IGG 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 VECTOR BEST SARS-COV-2 IGG ASSAY IS DESIGNED TO DETECT SPIKE ANTIBODIES. BASED ON CURRENT LITERATURE, IGG LEVELS MAY NOT APPEAR UNTIL 7 TO 10 DAYS AFTER INFECTION, LONG, Q-X, ET AL; HTTPS://WWW.NATURE.COM/ARTICLES/S41591-020-0897-1. 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, 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. IT REMAINS UNKNOWN FOR HOW LONG ANTIBODIES PERSIST FOLLOWING INFECTION AND IF THE PRESENCE OF ANTIBODIES IS INDICATIVE OF PROTECTIVE IMMUNITY. THE STUDY, QUAN-XIN LONG ET AL, ¿CLINICAL AND IMMUNOLOGICAL ASSESSMENT OF ASYMPTOMATIC SARS-COV-2 INFECTIONS¿, NATURE MEDICINE, HTTPS://DOI.ORG/10.1038/S41591-020-0965-6, 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 IGG 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. 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. 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. 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. 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 THE INVESTIGATION ARCHITECT SARS-COV-2 IGG REAGENT LOT 20100FN00 IS PERFORMING AS INTENDED, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT SARS-COV-2 IGG REAGENT WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE NEGATIVE ARCHITECT SARS-COV-2 IGG RESULT FOR A PATIENT. THE FOLLOWING DATA WAS PROVIDED: ARCHITECT SARS-COV-2 IGG = NEGATIVE. VECTOR BEST METHOD SARS-COV-2 IGG = POSITIVE. THE SAMPLE WAS CONFIRMED IN DUPLICATE ON EACH OF THE METHODS. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75610 SARS-COV-2-IGG REAGENT KIT REAGENT, CORONAVIRUS SEROLOGICAL QKO ABBOTT IRELAND 20100FN00

    Patients

    Seq Age Sex Outcome Treatment
    1