One Step SARS-CoV-2 Antigen Rapid Test Biocredit – 20 Pack test

EN ISO: 13485:2016

CE Marked

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BIOCREDIT COVID-19 Ag is a lateral flow immunochromatographic assay that adopted dual color system. The test contains colloid gold conjugate pad and a membrane strip pre-coated with antibodies specific to SARS-CoV-2 antigen on the test lines (T). If SARS-CoV-2 antigen is present in the specimen, a visible black band appears on the test lines (T) as antibody-antigen-antibody gold conjugate complex forms. The control line (C) is used for procedural control and should always appear if the test is performed correctly. For the qualitative detection of SARS-CoV-2 antigen from nasopharyngeal swab specimen with results in just 5-8 minutes

BIOCREDIT COVID-19 Ag has been evaluated with panel specimen by PCR. The results have shown Sensitivity levels of 92.0% and Specificity of 98%

Description

One Step SARS-CoV-2 Antigen Rapid Test Biocredit – 20 Pack test

BIOCREDIT COVID-19 Ag is a lateral flow immunochromatographic assay that adopted dual color system. The test contains colloid gold conjugate pad and a membrane strip pre-coated with antibodies specific to SARS-CoV-2 antigen on the test lines (T). If SARS-CoV-2 antigen is present in the specimen, a visible black band appears on the test lines (T) as antibody-antigen-antibody gold conjugate complex forms. The control line (C) is used for procedural control and should always appear if the test is performed correctly. For the qualitative detection of SARS-CoV-2 antigen from nasopharyngeal swab specimen with results in just 5-8 minutes

BIOCREDIT COVID-19 Ag has been evaluated with panel specimen by PCR. The results have shown Sensitivity levels of 92.0% and Specificity of 98%

The Rapid Biocredit Antigen Test from RapiGEN offers a fast and reliable solution for detection of SARS-CoV-2 antigen in remote applications and without the need for complex laboratory instruments at efficient cost and conveience.

Prueba rápida de antígeno de SARS-CoV-2 Biocredit– Pack 20 test_1

Performance Characteristics 

BIOCREDIT COVID-19 Ag has been evaluated with panel specimen by PCR. The results are summarized in the following table:

  1. Sensitivity and Specificity

Prueba rápida de antígeno de SARS-CoV-2 Biocredit– Pack 20 test

  1. 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 time3. Reactividad cruzada:

BIOCREDIT COVID-19 Ag se ha probado con 20 microorganismos y virus con potencial

reacción cruzada. Los resultados mostraron ausencia de reactividad cruzada, a

excepción de una muy débil reacción con el coronavirus tipo SARS

  1. Cross reactivity

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

  1. Interference:

BIOCREDIT COVID-19 Ag has been tested with 14 potentially interfering endogenous or exogenous substances. The results showed that BIOCREDIT COVID-19 Ag had no interference with endogenous or exogenous substances except very weak interference with HAMA Type I.

Use mode:

 

KIT Components

  • Each test device sealed in a foil pouch with a desiccant
  • Assay diluent tube – Filter cap
  • Sterilized swab for nasopharyngeal specimen collection
  • Instructions for us

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