Health
The widely used SARS-CoV-2 rapid antigen detection test continues to function as expected despite the Omicron mutation.
Recent studies posted on medRxiv* Preprint server quickly evaluated the performance of three home coronavirus diseases 2019 (COVID-19) antigen Severe Acute Respiratory Syndrome A commonly used test in the United States (US) for coronavirus 2 (SARS-CoV-2) omicron variants.
The SARS-CoV-2 Rapid Antigen Detection Test (RADT) is now widely used in the United States because it is self-managing, with no or few equipment, and results in less than 15 minutes. In addition, RADT plays an important role in alleviating stringent COVID-19-related restrictions in society, as these tests can be used at the onset of SARS-CoV-2 symptoms or at the time of treatment prior to assembly. .. However, these tests should be reassessed on a regular basis to ensure that test performance does not degrade when the virus mutates.
Most RADTs target the SARS-CoV-2 nucleoprotein (N) protein, and Omicron variants carry multiple previously unidentified N protein mutations. However, the effect of Omicron mutations on RADT efficiency remains unclear.
About research
In this study, researchers evaluated the effect of Omicron mutations on the efficiency of three COVID-19 rapid antigen test kits (1) iHealth COVID-19 Antigen Rapid Test, 2 widely used at home. ) ACON Laboratories FlowFlex COVID-19 Antigen Home Test, and 3) Abbott Binax NOW COVID-19 Antigen Card. Scientists evaluated the performance of three SARS-CoV-2 RADTs in 30 Omicron and Delta variant samples, each with a wide range of viral loads, and the Delta sample set acted as a comparator for the study.
With the exception of nine delta samples collected between August and November 2021, researchers were found to be from patients seeking medical care at Massachusetts General Hospital between November 30 and December 27, 2021. And 30 samples positive for the delta variant were procured.
Samples were taken from the patient’s anterior nasal passages and analyzed using the Roschcobus SARS-CoV-2 reverse transcriptase-polymerase chain reaction (RT-PCR) assay. In addition, the SARS-CoV-2 variant was identified via the TaqPath COVID-19 combo kit.
Survey results
The results show that all three RADTs evaluated had similar analytical sensitivities for detecting the SARS-CoV-2 omicron variant compared to the delta variant. However, there was performance variability among the three assays.
Over the overlap of eight PCR cycles, Abbott BinaxNOW COVID-19 RADT is positive and negative for SARS-CoV-2, which corresponds to a 256-fold variation in viral load in the sample, assuming 100% reaction efficiency. The result of is shown. In contrast, the extent of FlowFlex RADT overlap was limited to 3 PCR cycles. This represents a variation of 8 times the SARS-CoV-2 concentration in the sample.
No RADT detected samples with a cycle threshold (Ct) value of 27.5 or higher for the SARS-CoV-2 envelope (E) gene target shown in the Roche cobas RT-PCR assay.
The SARS-CoV-2 variant did not predict the likelihood of a positive test after controlling RADT and Ct values ​​in multivariate analysis. Nonetheless, the Abbott BinaxNOW COVID-19 Antigen Card showed an 89% lower chance of a positive Omicron sample compared to the iHealth COVID-19 RADT. In addition, no statistically related variation in the probability of being positive was observed between FlowFlex and iHealth COVID-19 RADT.
Conclusion
Studies show that despite the addition of mutations to Omicron N, three commonly used RADTs targeting the SARS-CoV-2 N protein in the COVID-19 self-test in the United States are mutated. It shows that it is still efficient in detecting the body. The analytical sensitivity of RADT did not change between the Omicron and Delta variants containing the sample, but there was variation in performance based on the type of assay. Nevertheless, given the limited sample size of current studies, these findings should be interpreted with caution and investigated in future studies.
In addition, the team reported a slight trend in low detection of SARS-CoV-2 omicron variants using Abbott BinaxNOW COVID-19RADT, which was also observed in previous studies using different sample sets.
According to the author, this is the first study to independently evaluate the performance of the iHealth COVID-19 test on Omicron mutants. Although not important, the iHealthCOVID-19 test demonstrated greater sensitivity and difference between SARS-CoV-2 positive and negative results compared to FlowFlex RADT.
It was unclear why the AbbottBinax NOW and FlowFlex COVID-19 RADT had overlapping viral loads, so further investigation is needed to determine if these fluctuations are reproducible in other settings.
Overall, this study established a baseline for comparison of COVID-19 RADT with future SARS-CoV-2 variants, and home COVID-19 testing compared with previous waves of SARS-CoV-2. And guarantee that it works as expected. Pandemic.
*Important Notices
medRxiv publishes unpeer-reviewed preliminary scientific reports and should not be considered definitive, guide clinical / health-related behaviors, or be treated as established information.
Sources 2/ https://www.news-medical.net/news/20220222/Widely-utilized-SARS-CoV-2-rapid-antigen-detection-tests-continue-to-perform-as-expected-despite-Omicron-mutations.aspx The mention sources can contact us to remove/changing this article |
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