| Catalog Number 06R87-22 |
| Device Problem
False Positive Result (1227)
|
| Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
| Event Date 01/06/2021 |
|
Event Type
malfunction
|
|
Event Description
|
|
The customer observed false positive sars-cov-2 igm results generated on the architect i1000sr processing module for multiple samples.The samples generate negative results for sars-cov-2 igg but positive results for sars-cov-2 igm and it does not correlate with clinical symptoms of the patient.Pcr has been tested on some samples and were negative.The following data was provided: patient 1: 11jan igm = 4.13, igg = 5.4; 04may igm = 1.0, igg = 3.59.Patient 2: 24mar igm = 3.2, igg = 7.9; 21apr igm = 0.8, igg = 8.1; 04may igm = 2.65, igg = 3.1.Patient 3: 11jan igm = 1.65, igg = 4.3; 04may igm = 0.9, igg = 1.88.Patient 4: 17feb igm = 17.65, igg = 7.4; 10mar igm = 16.5, igg = 7.4; 04may igm = 5.67, igg = 9.6.Patient 5: 04mar igm = 1.65, igg = 5.4; 04may igm = 1.25, igg = 3.3.Patient 6: 06jan igm = 0.9, igg = 5; 01apr igm = 0.9, igg = 1.9; 04may igm = 1.13, igg = 2.Patient 7: 06mar igm = 2.28, igg = 8.5; 04may 1.15, igg = 6.2.Patient 8: 04mar igm = 8.95, igg = 8; 04may igm = 7.2, igg = 4.05.Patient 9: 06jan igm = 3.44, igg = 3.2; 04mar igm = 2.63, igg = 2; 04may igm = 2.33, igg = 1.4.Patient 10: 01apr igm = 1.51, igg = 9.3; 04may igm = 2.6, igg = 2.37.Patient 11: 06jan igm = 9.21, igg = 9.3; 04mar igm = 3.14, igg = 7.9, 04may igm = 22.08, igg = 8.Patient 12: 08mar igm = 5.56, igg = 7.5; 18may igm = 2.0, igg = 7.3.Patient 13: 03mar igm = 3.0, igg = 7.8; 09mar igm = 2.82, igg = 7.4, 18may igm = 1.22, igg = 9.7.Patient 14: 09mar igm = 5.28, igg = 6.8; 18may igm = 1.15, igg = 5.1.Patient 15: 08mar igm = 4.7, igg = 7.3; 18may igm = 1.1, igg = 7.2.Patient 16: 08mar igm = 3.99, igg = 6.1; 18may igm = 1.37, igg = 4.Patient 17: 24mar igm = 3.59, igg = 6.9; 04may igm = 2.94, igg = 5.9.Patient 18: 24mar igm = 6.78, igg = 10.0; 21apr igm = 2.1, igg = 10.2; 04may igm = 2.0, igg = 10.1.Patient 19: 19feb igm = 1.22, igg = 3.7; 08mar igm = 5.12, igg = 7.9; 04may igm = 2.29 igg = 11.1.Patient 20: 23feb igm = 3.71, igg = 3.5; 23mar igm = 0.9, igg = 5.9; 05may igm = 1.2, igg = 2.34.Patient 21: 10mar igm = 55.6, igg = 8.9; 04may igm = 6.62, igg = 8.4.The samples are from patients who work at a mining site and their protocol is to run igm, igg and pcr on their workers, but if igm comes out positive, the mine workers cannot go to work.No impact to patient management was reported.
|
| |
|
Manufacturer Narrative
|
|
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.
|
| |
|
Manufacturer Narrative
|
|
This report is being filed on an international product, list number 6r87-22 (sars-cov-2 igm) that has a similar product distributed in the us, list number 6r87-20/-30 (advisedx sars-cov-2 igm: eua # (b)(4)).The complaint investigation for false positive sars-cov-2 igm results included a search for similar complaints, and the review of complaint text, trending data, labeling, device history records, and in-house testing with a retained kit of lot 27104fn00.Return testing was not completed as returns were not available.Labeling was reviewed and sufficiently addresses the customer's issue.Device history record review on lot 27104fn00 did not show any potential non-conformances, or deviations.In-house specificity and sensitivity testing were done using an in-house retained kit of lot 27104fn00, stored at the recommended storage conditions.All validity and acceptance criteria were met indicating that the lot is performing acceptably.In this case, the samples were positive for igm and igg indicating that antibody is present in the samples.Per igm product labeling, the host immune system reacts to the infection by sars-cov-2 by producing specific antibodies.These antibodies have been reported to appear in serum or plasma of infected individuals after the detection of viral ribonucleic acid (rna) in swabs and a few days to 2 weeks after the onset of symptoms.Specific igm antibodies to sars-cov-2 may be detectable in covid-19 patients during the symptomatic phase of the disease after rna is no longer detectable.At this time, duration and strength of the igm antibody response continue to be characterized; the kinetics of this response are unknown.The analytical specificity of the sars-cov-2 igm assay was evaluated for potential cross reactivity from individuals with other medical conditions.A total of 208 specimens from 43 different categories were tested with two hundred six (206) specimens returning negative results.2 specimens were positive by the sars-cov-2 igm assay with one specimen from a hemodialysis patient and the other specimen from the rf category.Per the clinical performance section of the package insert, a study was performed to estimate the negative percent agreement (npa), 2965 serum and plasma specimens from subjects assumed to be negative for sars-cov-2 were tested using the sars-cov-2 igm assay.All of the specimens were collected prior to september 2019 (pre-covid-19 outbreak).The npa is 99.56% (95% ci: 99.25, 99.74).The publication ¿longitudinal characterization of the igm and igg humoral response in symptomatic covid-19 patients using the abbott architect¿, g.N.Maine et al., https://doi.Org/10.1016/j.Jcv.2020.104663, evaluated the clinical performance of abbott sars-cov-2 igm and igg assays, as well as the longitudinal dynamics of the antibody response in symptomatic covid-19 patients.Clinical test sensitivity of the sars-cov-2 igm assay demonstrated that peak test sensitivity was reached at 4 to 5 weeks (96%) post symptom onset.A study of the longitudinal dynamics of igm in sars-cov-2 infected patients shows that igm levels declined steadily 4 to 5 weeks after symptom onset, and the positive rate dropped to 30.8 % at >3 months.The publication further documents that igm can persist in a small proportion of individuals beyond 3 months.Additionally, the publication ¿characterization of antibody responses to sars-cov-2 in convalescent covid-19 patients¿, liu c, yu x, gao c, et al, https://doi.Org/10.1002/jmv.26646 , does not involve use of the abbott assay but demonstrated that igm reached its highest positivity rate (90.4%) in the first month after symptom onset.The positivity rate for igm declined over time however some individuals remained positive 6 months after symptom onset.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 sars-cov-2 igm reagent lot 27104fn00 is performing as intended, no systemic issue or deficiency was identified.Section describe event or problem was updated to correctly show the sars-cov-2 igg results were positive for all patients.
|
| |
|
Event Description
|
|
Clarifying information was provided by the customer: the customer observed false positive sars-cov-2 igm results generated on the architect i1000sr processing module for multiple patients which did not correlate with clincial symptoms.The samples generated positive results for both the sars-cov-2 igm and sars-cov-2 igg assays.However, the customer is not questions the positive sars-cov-2 igg results and only inquiring about the positive sars-cov-2 igm results.
|
| |
|
Search Alerts/Recalls
|
|
