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BIOCREDIT COVID-19 Ag

One Step SARS-CoV-2 Antigen Rapid Test

BIOCREDIT COVID-19 Ag

One Step SARS-CoV-2 Antigen Rapid Test

Biocredit Covid-19 Ag is a medical technology product IVD (in vitro diagnostic medical device), which is manufactured by the company RapiGEN INC. and is distributed in Greece by the company ASK Pharmaceutical. Biocredit Covid-19 Ag is utilizing the principle of immunochromatographic analysis.

In Biocredit COVID-19 Ag, the capsid N protein is defined as the antigen (from the coronavirus nucleocapsid), thus the antigen test measures whether the capsid N protein of the SARS – CoV-2 is present in the sample. The nitrocellulose membrane of the device, hereinafter substrate, has the ability to transfer the sample naturally using the diffusion-wetting principle. This substrate acts as a “sponge” and retains excess liquid from the test sample. If the sample is positive, the antibodies that are conjugated to the chromophore (gold particles) bind to the corresponding antigen (protein N).

The complex of antigens and chromophore-conjugated antibodies flows to the rest of the substrate, interacts with the pre-coated areas, and accordingly yields a typical color change. There are typically two areas: one referred to as the control area, which traps any molecule and thus ensures that the analysis process is completed correctly, and the second area, the test area, which contains a specialized trapped molecule that binds only to the complex of antigens and chromophore-conjucated antibodies of the sample.


Patient Instructions Leaflet
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Performance Characteristics



Sensitivity and Specificity

Biocredit Covid 19 Ag has been evaluated comparing to PCR as reference at 3 different countries.


Precision

Within-run and between run precision has been determined in triplicates of three lots using the following specimen panel : negative, low positive, medium positive and strong positive. All specimens are correctly identified 100% of the time.


Cross reactivity

Biocredit Covid 19 Ag has been tested with 20 potentially cross reacting microorganisms and viruses. The results showed no cross-reaction with microorganisms and viruses except very weak cross reacting with SARS-coronavirus.


Interference

Biocredit Covid 19 Ag has been tested with 14 potentially interfering endogenous or exogenous substances. The results showed no interference with endogenous or exogenous substances.

Kit Components


Each test device sealed in a foil pouch with a desiccant X 20

Sterilized swab for nasopharyngeal specimen collection X 20

Assay diluent tube X 20

Filter cap X 20

Instructions for use X 1

Frequently asked questions


  • At what stage of the pandemic is the use of BIOCREDIT COVID-19 Ag, One Step SARS-CoV-2 Antigen Rapid Test recommended?
  • Is it indicated for diagnosis in the whole population?
  • I have cold symptoms. Can I perform the test myself?
  • Can I find out if I had COVID-19 in the past by having an antigen test?
At what stage of the pandemic is the use of BIOCREDIT COVID-19 Ag, One Step SARS-CoV-2 Antigen Rapid Test recommended?

Rapid Antigen testing is recommended in cases of pandemic outbreaks, where rapid detection of positive cases is necessary to stop the transmission of Covid-19.

Is it indicated for diagnosis in the whole population?

It is indicated for people who have symptoms similar to Covid-19, in order to determine whether or not they have been infected with the SARS-CoV-2 virus. In people without obvious symptoms, there is no need for a rapid antigen test. This means that a negative result does not rule out a recent infection, asymptomatic carriers, individuals coming out of the infection stage and recovering, or an error in the sample collection process by the examiner.

I have cold symptoms. Can I perform the test myself?

The product is intended for use by health professionals only. All necessary protective measures should be taken when collecting the sample. A clinical decision should be made by a doctor after evaluating all clinical and laboratory findings. According to the World Health Organization, the most reliable method for the diagnosis of acute COVID-19 syndrome is the molecular method RT-PCR, because it shows the highest sensitivity and specificity in samples of the upper respiratory tract.

Can I find out if I had COVID-19 in the past by having an antigen test?

No, the antigen test examines the presence of the COVID-19 virus in a nasopharyngeal swab at the time of the test.

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