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COVID-19 Antigen Test

Result in 15 minutes 

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Available Now

MARK-B COVID-19 Antigen Test

Simple . Accurate . Fast .

The MARK-B™ COVID-19 Ag test is a electrochemical sandwich immunoassay that is used with the MARK-B™ 1 analyzer intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal swab specimens.

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34mm

34mm

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MARK-B™ COVID-19 Ag are CE marked, MFDS Approved*.

*MARK-B™ COVID-19 Ag [체외 제허 21-673호]

Point of Care Testing

Test results in 15 minutes

Fast diagnosis with results in 15 minutes in various locations such as clinical laboratories, hospitals etc.

Turn-around Time

Sensitivity  93%

specificity  100%

 

Frozen Nasopharyngeal Swab

The clinical performance of MARK-B™ COVID-19 Ag was evaluated with frozen nasopharyngeal swab specimens, which have been collected from multiple sites in the United States between September 2020 and April 2021, against a commercial RT-PCR molecular assay as a reference method. To be enrolled in the study, patients had to be presenting at the sites with COVID-19 like symptoms within 8 days of symptom onset. the RT-PCR assay and a total of 207 samples including 72 positive and 135 negative specimens were selected for the study. MARK-B™ COVID-19 Ag test was performed by minimally trained operators who are representative of the intended users. The clinical performance of MARK-B™ COVID-19 Ag was concluded as a sensitivity of 93% (67/72) and a specificity of 100% (135/135).

*Molecular assay: Allplex™ 2019-nCoV Assay

Nasopharyngeal Swab in Viral Transport Medium

The clinical performance of MARK-B™ COVID-19 Ag was evaluated with nasopharyngeal swab specimens in viral transport medium, which have been collected from multiple sites in the United States between September 2020 and February 2021, against a commercial RT-PCR molecular assay as a reference method. To be enrolled in the study, patients had to be presenting at the sites with COVID-19 like symptoms within 22 days of symptom onset. the RT-PCR assay and a total of 170 samples including 60 positive and 110 negative specimens were selected for the study. The specimens were tested based on the Instruction For Use of the MARK-B™ COVID-19 Ag test cartridge. The clinical performance of MARK-B™ COVID-19 Ag was concluded as a sensitivity of 90% (54/60) and a specificity of 99% (109/110).

*Molecular assay: Real-Q 2019-nCoV detection Kit

Accuracy

Limit of Detection

Specification

  • Direct nasopharyngeal swab

  • Simple operation via visual touchscreen on MARK-B™ 1 analyzer

  • Assay kit contains necessary components for testing to include
  • Accurate test result in 15 minutes or less

PRODUCT PACKAGE COMPONENTS

25 MARK-B™ COVID-19 Ag test cartridges are provided in the package, which can be used to analyze up to 25 samples provided in the package. The package contains the following:

  • MARK-B™ COVID-19 Ag (25)

  • Reagent Tubes (25)

  • Sterile nasopharyngeal swabs (25) 

  • Dropper caps (25)

  • Package insert (1) 

  • Quick Reference Guide (1)

MATERIALS NOT SUPPLIED

  • MARK-B™ 1 analyzer (Model# MB-100)

  • System check cartridge (for use with MARK-B™ 1 analyzer)

  • Barcode scanner

  • Printer

  • MARK-B™ COVID-19 Ag Control Solutions (Model# ID032512-CST)

  • Any necessary personal protective equipment

How to test 'MARK-B COVID-19 Ag'

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