Abstract
Background: RT-qPCR is the reference test for identification of active SARS-CoV-2 infection, but is associated with diagnostic delay. Antigen detection assays can generate results within 20 min and outside of laboratory settings. Yet, their diagnostic test performance in real life settings has not been determined.
Methods: The diagnostic value of the Panbio™ COVID-19 Ag Rapid Test (Abbott), was determined in comparison to RT-qPCR (Seegene Allplex) in community-dwelling mildly symptomatic subjects in a medium (Utrecht, the Netherlands) and high endemic area (Aruba), using two concurrently obtained nasopharyngeal swabs.
Findings: 1367 and 208 subjects were enrolled in Utrecht and Aruba, respectively. SARS-CoV-2 prevalence, based on RT-qPCR, was 10.2% (n = 139) and 30.3% (n = 63) in Utrecht and Aruba respectively. Specificity of the Panbio™ COVID-19 Ag Rapid Test was 100% (95%CI: 99.7-100%) in both settings. Test sensitivity was 72.6% (95%CI: 64.5-79.9%) in the Netherlands and 81.0% (95% CI: 69.0-89.8%) in Aruba. Probability of false negative results was associated with RT-qPCR Ct-values, but not with duration of symptoms. Restricting RT-qPCR test positivity to Ct-values <32 yielded test sensitivities of 95.2% (95%CI: 89.3-98.5%) in Utrecht and 98.0% (95%CI: 89.2-99.95%) in Aruba.
Interpretation: In community-dwelling subjects with mild respiratory symptoms the Panbio™ COVID-19 Ag Rapid Test had 100% specificity, and a sensitivity above 95% for nasopharyngeal samples when using Ct-values <32 cycles as cut-off for RT-qPCR test positivity. Considering short turnaround times, user friendliness, low costs and opportunities for decentralized testing, this test can improve our efforts to control transmission of SARS-CoV-2.
Conflict of interest statement
Dr. Wensing reports grants from ViiV Healthcare, Gilead, grants from Janssen, Gilead, Merck, grants from Janssen, Gilead, Merck, ViiV Healthcare, grants from ARK diagnostics, outside the submitted work. All other authors report no conflict.
Product Specification
| Number of Reactions(Preps) per Kit | 1 |
| Brand | Abbott Panbio |
| ICMR Approved | Yes |
| Test Method | Antigen Test |
| Result Time (Rapid Kits) | 15 min |
| Sample Type | Nasal Swab |
| Packaging Size | 25 Test Kits/Box |
| Country of Origin | Made in India |
| Packaging Type | Box |
Product Description
Abbott has received CE mark for the use of its Panbio COVID-19 Ag Rapid Test Device to detect the SARS-COV-2 virus in paediatric patients aged 15 years and below.
A lateral flow assay for rapid, qualitative detection of the virus, the test provides results in as little as 15 minutes with no instrumentation.
For collecting samples from people to carry out the test, a minimally invasive nasal or nasopharyngeal swab can be used.
In January, Abbott received CE mark for its Panbio COVID-19 Ag Rapid Test Device to detect the SARS-CoV-2 virus for two new uses, in asymptomatic individuals and self-swabbing testing.
Abbott noted that the test has been added to the World Health Organization’s Emergency Use Listing (WHO EUL). The company now plans to submit performance data in children to update the existing label.
The latest approval is based on a study that assessed the performance of a rapid antigen test on children, including infants.
Interim study results on nasal swab samples obtained from 274 children aged 15 years and below showed that the Panbio COVID-19 Ag Rapid Test Device had an overall sensitivity of 76.3% and specificity of 100%, as against PCR test results.
Furthermore, a sensitivity of 92.9% was observed in 42 samples with cycle threshold (Ct) values less than or equal to 30 and 82.7% in 52 samples with Ct values less than or equal to 33.
Molecular Innovations name, SARS-CoV-2 IgG Seroconversion ELISA Kit and product number, SARSCOV2GKT.
This SARS-CoV-2 IgG Seroconversion ELISA Kit from Innovative Research is intended for the qualitative determination of SARS-CoV-2 specific antibodies of IgG class in plasma or serum samples. Strip well format. Reagents for up to 96 tests. For research only.Â
This assay has been specifically developed using the SARS-CoV-2 receptor binding domain (RBD) of the spike protein. This delivers reliable and consistent results with a high degree of reproducibility.Â
This assay can be performed in 70 minutes, and has an overall sensitivity of 97-100% and specificity of 100%.
Principle of the Assay:
SARS-CoV-2 specific antibodies will bind to the purified recombinant HEK cell derived receptor-binding domain (RBD) of the SARS-CoV-2 spike protein coated on the microtiter plate. After appropriate washing steps, horseradish peroxidase labeled polyclonal anti-human IgG secondary antibody binds to the captured protein. Excess secondary antibody is washed away and TMB substrate is used for color development at 450 nm. Samples that exceed a determined cut-off value are designated positive by this assay.
More Details:
- Detection Target: SARS-CoV-2 specific antibodies of isotype IgG
- Dilution of Samples: A 1:51 dilution of serum samples is suggested for best results.
- Expected Values: Significant seroconversion as demonstrated by antibodies specific to both the full-length SARS-CoV-2 spike protein and the RBD region has been detected as early as two days post symptom onset.
- Sensitivity:Â 97% for samples obtained more than 14 days after symptom onset (n=37), 100% for samples obtained more than 21 days after symptom onset (n=32).
- Specificity:Â 100% (n=89)
- Percent Agreement: Positive 100%; Negative 91%
- Storage: Store all kit components at 4°C upon arrival. Return any unused microplate strips to the plate pouch with desiccant. Reconstituted controls may be stored at -80°C for later use. Store all other unused kit components at 4°C. This kit should not be used beyond the expiration date.
Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary. Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as KHU1, NL63, OC43, or 229E. This serological assay can be used for applications like characterizing immune responses to viral infection by determining the presence of viral antigen-specific antibodies in infected and recovered patient sera. At Innovative Research, we provide reliable, consistent products that deliver reliable, consistent results.
This material is sold for in-vitro use only for manufacturing and research. This material is not suitable for human or animal use. While we make every effort to ensure the safety of our products, we recommend handling any biological materials with standard precautions as if capable of spreading infectious disease. The statements herin are offered for informational purposes only to be used solely for your consideration, investigation, and verification.
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