MAUDE Adverse Event Report: ABBOTT IRELAND SARS-COV-2 IGG II QUANT REAGENT KIT; SARS-COV-2 LGG

Catalog Number 06S61-22

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/26/2021

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.(b)(6).All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 06s61-22, that has a similar product distributed in the us, list number 06s61-20.

Event Description

The customer observed a false negative sars-cov-2 igg ii quant result for one patient, post-vaccination, on an alinity i analyzer.The following data was provided (<50.0 au/ml is negative, >/=50.0 au/ml is positive): sample id (b)(6) initial result was 32.1 au/ml.The sample was repeated using a diasorin assay, under sample ids (b)(6), and the results were 16.1 and 16.4 au/ml, which are positive.The sample was also tested using a roche assay and the result was 13.0 u/ml, which is positive and the nucleocapsid result was 0.491 coi, which is negative.There was no impact to patient management reported.

Manufacturer Narrative

The complaint investigation for false negative alinity i sars-cov-2 igg ii quant results included a search for similar complaints, the review of complaint text, trending data, labeling, and device history records.Sensitivity and specificity testing was done using an in-house retained kit of lot 27088fn00, stored at the recommended storage conditions.All validity and acceptance criteria were met indicating that the lot is performing acceptably.Device history record review on lot 27088fn00 did not show any potential non-conformances or deviations.Labeling was reviewed and found to adequately address the issue under review.The customer obtained a negative result of 32.1 au/ml for an (b)(6) vaccinated patient when testing was performed with alinity sars-cov-2 igg ii quant, reagent lot 27088fn00 in comparison to positive results obtained with the roche total spike antibody assay (13.0 u/ml, cutoff >0.8 u/ml) and the diasorin liaison cov2-g assay (16.1 and 16.4 au/ml).In this case, per the data provided, the sample was collected on the (b)(6) 2021 and tested 9 days later on (b)(6) 2021 with a negative but elevated result obtained.The vaccination date was not provided, and no other patient information was provided.The article, ¿safety, tolerability, and immunogenicity of an inactivated sars-cov-2 vaccine (coronavac) in healthy adults aged 60 years and older: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial¿, zhiwei wu et al, lancet infect dis 2021;21: 803¿12, https://doi.Org/10.1016/s1473-3099(20)30987-7 documents that studies have shown that individuals aged 60 years or older the response to vaccines is usually reduced in older adults because of immune senescence, the age-related changes that affect many of the cellular and molecular elements of both the innate and adaptive immune systems.Therefore, testing the effectiveness of covid-19 vaccines in this population is necessary.Regarding the differences in the values between the abbott, roche, and diasorin assays, this could potentially be due to the different assay formats.The abbott assay detects igg antibodies, including neutralizing antibodies, to the receptor binding domain (rbd) of the s1 subunit of the spike protein.The roche total assay is a quantitative determination of antibodies (including igg) to the sars-cov-2 spike (s) protein receptor binding domain (rbd).The dissorin assay is a quantitative assay for the detection of igg antibodies against s1/s2 antigens of sars-cov-2.Review of the publication ¿longitudinal variation in sars-cov-2 antibody levels and emergence of viral variants: implications for the ability of serological assays to predict immunity¿, muecksch f et al med, rxiv preprint doi: https://doi.Org/10.1101/2021.07.02.21259939, contains performance data for the abbott sars-cov-2 igg ii assay compared to other assays (including roche s and diasorin s1/s2) for sensitivity over time and correlation to neutralization methods, which shows the good performance of the abbott sars-cov-2 igg ii assay.Per the publication, in addition to indicating whether a serum sample is negative or positive for antibodies against viral antigens, each assay indicates quantitative antibody levels within assay-specific scales.Analysis of antibody levels over time showed assay dependent differences in trajectory that were not dependent on whether nucleocapsid or spike antigens were used.In this study, correlation with neutralizing antibody titers was assessed and it was shown that assays measuring spike specific igg antibodies predicted neutralizing antibody titers more accurately than those measuring total antibodies against spike regardless of class or those against the nucleocapsid protein.In addition, declines in antibody levels over time did not, in some cases, accurately reflect the decrease in neutralization activity.The diasorin assays, abbott iggii, siemens scovg, euroimmun and cpass had the highest correlation with neutralizing antibody titers across all comparisons and changes in quantitative values over time for these assays were most closely correlated with changes in neutralizing antibody levels within individuals.The quantitative results from these assays are therefore best suited for estimating neutralizing antibody levels at a population level.Per the clinical performance section of the package insert, assay sensitivity (ppa) at = 15 days post-symptom onset is 99.35% (95 % ci 96.44, 99.97) and when immunocompromised patients were included, the ppa at = 15 days post-symptom onset was 97.01% (95% ci: 93.18, 98.71).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, alinity i sars-cov-2 igg ii quant reagent, lot number 27088fn00, is performing as intended, no systemic issue or deficiency of the reagent was identified.

• Brand Name: SARS-COV-2 IGG II QUANT REAGENT KIT
• Type of Device: SARS-COV-2 LGG
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• MDR Report Key: 12233688
• MDR Text Key: 282338867
• Report Number: 3008344661-2021-00147
• Device Sequence Number: 1
• Product Code: QKO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/03/2021
• Device Catalogue Number: 06S61-22
• Device Lot Number: 27088FN00
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALNTY I PROCESSING MODU, 03R65-01, (B)(4); ALNTY I PROCESSING MODU, 03R65-01, (B)(4)