Common List COVID-19 Omicron Antigen Test 3 in 1 with 3rd Party Clinic Report

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Used For	Common List COVID-19 Omicron Antigen Test 3 in 1
Specimen	Nasopharyngeal/Oropharyngeal/Nasal Swa
Certification	Common List/bfarm/PEI
MOQ	5000 test kits
Delivery time	1 week after Get payment
Packing	1 test kits/Packing box,20 test kits/Packing box
Test Data	96.3% accuracy
Shelf Life	2 years

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Common List COVID-19 Omicron Antigen Test 3 in 1 with 3rd Party Clinic Report

Abtract from 3rd Part Clinic test report

The Immuno Biotech Antigen Rapid Test is an assay that can be used for the diagnosis of SARSCoV-2 infection. This assays tests for the presence of SARS-CoV-2 N-protein is swab specimen. In this study, the Immuno Biotech antigen rapid test was evaluated with the Roche SARS-CoV-2 Rapid Antigen Test Nasal and the PCR. PerkinElmer reverse transcriptase real time quantitative polymerase chain reaction (rt-RT-qPCR) was used for discrepancy analysis. In total, 80 negative and 40 positive COVID-19 samples were included in this comparison. The sensitivity of the Immuno biotech antigen rapid test was determined to be 92,5% (95% CI: 86,4%-96,0%). Below a Cp value of 32.6 the sensitivity was 100%. The specificity 100% (95% CI: 96,9%-100%) and the accuracy of 97,5% (95% CI: 92,9%-99,1%). The Immuno Biotech rapid antigen tests detected all thirteen variants of SARS-CoV-2 variant panel 1 and 2. However, variant 27390 was detected as weak positive. The lowest detectable concentration was around 140.000 dPCR copies/mL. The Roche antigen rapid test had exactly the same results and detected the same samples as false negative. Furthermore, the Roche antigen rapid test also showed a limit of detection around 140.000 dPCR copies/mL. The performance of the antigen rapid tests are similar in this evaluation.

You may be concerned about whether our products can detect mutated COVID-19 strains?

Besides the COVID Delta Strain, Recently, the Sars-CoV-2 new variant Omicron (B.1.1.529) strains were spreading from South Africa and across the world and makes it more difficult to prevent and control. The mutation sites on the nucleocapsid protein (N protein) are located at DEL31/33, P13L, R203K, and G204R, where are all out of the epitope region (N47-A173, NTD region) recognized by our antibody pairs. Thus, the Sars-CoV-2 Antigen Rapid Test (COVID-19 Ag) is theoretically competent for the detection of the Sars-CoV-2 new variant Omicron strains.

Meanwhile, our Sars-CoV-2 Antigen Rapid Test (COVID-19 Ag) is still working on the WHO concerned variant stains on their N proteins, including UK variant B.1.1.7, Brazil variant P.1, South Africa variant B.1.351, and India variants B.1.617 and B.1.617.2.

About the quality of IMMUNO COVID-19 Test?

From the beginning of the covid-19 epidemic, our experimenters used their own expertise to develop products related to the detection of covid-19. From covid igg/igm antibody test to covid antigen test and covid nuetralizing antibody test. We have been contributing modest efforts to the world’s epidemic prevention work.
The IMMUNO covid antigen test is used in testing institutions and hospitals in Argentina, Germany, Italy, Romania, Poland, the United Kingdom, Denmark and other countries. We are honored to receive the trust and appreciation of our products from professionals from various countries.

About IMMUNOBIO

we are a national high-tech enterprise with own production, R&D, and export teams.

Since the outbreak of the new COVID at the end of 2019, we have begun to develop COVID-19 testing products.

In February 2020, in just 2 months, we successfully developed the IGG/IGM antibody test and provied strong support to Argentina.

In August 2020, we successfully developed COVID-19 Antigen test and provide high-quality products to Germany.

Realizing that the COVID-19 may become a routine desease that can only be prevanted by vaccine immunization, and that the previous vaccines have not been fully verified by the populaion, we began to introduce Neutralizing antibody tests. Ensuring the effectiveness of vaccines at the individual level adds a layer of protection to epidemic prevention.

TEST PROCEDURE

Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.
1. Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and horizontal surface. Reverse the specimen collection tube, extrude 3 drops of the prepared specimen into the specimen well (S) of the test cassette and start the timer.
See illustration below.