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Orient Gene Coronavirus Ag Rapid test (Swab)

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The Coronavirus Ag Rapid Test Cassette (Swab) is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein...
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The Coronavirus Ag Rapid Test Cassette (Swab) is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) swab specimens directly or after the swabs have been added to viral transport media from individuals who are suspected of COVID-19 by their healthcare provider.

It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections. The Coronavirus Ag Rapid Test Cassette (Swab) does not differentiate between SARS-CoV and SARS-CoV-2.

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source.

Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue, and dry cough. Nasal congestion, runny nose, sore throat, myalgia, and diarrhea are found in a few cases.

This test is for detection of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Rapid diagnosis of SARS-CoV-2 infection will help healthcare professionals to treat patients and control the disease more efficiently and effectively.

Testing is limited to use by certified medical personal only. Product Usage Register is to be kept updated at all times for traceability. No sale outside of healthcare sector permitted.

The Coronavirus Ag Rapid Test Cassette (Swab) is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect nucleocapsid protein from SARS-CoV-2 in direct nasopharyngeal (NP) swab.

The test strip is composed of the following parts: namely sample pad, reagent pad, reaction membrane, and absorbing pad. The reagent pad contains the colloidal-gold conjugated with the monoclonal antibodies against the nucleocapsid protein of SARS-CoV-2; the reaction membrane contains the secondary antibodies for nucleocapsid protein of SARS-CoV-2.

The whole strip is fixed inside a plastic device. When the sample is added into the sample well, conjugates dried in the reagent pad are dissolved and migrate along with the sample. If SARS-CoV-2 nucleocapsid antigen is present in the sample, a complex forms between the antiSARS-2 conjugate and the virus will be captured by the specific anti-SARS-2 monoclonal antibodies coated on the test line region (T).

Absence of the test line (T) suggests a negative result. To serve as a procedural control, a red line will always appear in the control line region (C) indicating that proper volume of sample has been added and membrane wicking has occurred.

Clinical Performance of the Coronavirus Ag Rapid Test (Swab) was evaluated by being involved in 7 non-laboratory sites within the US, where patients were enrolled and tested.

Testing was performed by 24 non laboratorian Health Care Workers that were not familiar with the testing procedure.

A total of 317 fresh nasopharyngeal swab samples was collected and tested, which includes 61 positive samples and 256 negative samples.

The Coronavirus Ag Rapid Test (Swab) results were compared to results of Emergency Use Authorized RT-PCR assays for SARS-CoV-2 from nasopharyngeal swab specimen.

 

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Orient Gene Coronavirus Ag Rapid test (Swab)
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