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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.
34mm
34mm
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
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Direct nasopharyngeal swab
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Simple operation via visual touchscreen on MARK-B™ 1 analyzer
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Assay kit contains necessary components for testing to include
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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:
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MARK-B™ COVID-19 Ag (25)
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Reagent Tubes (25)
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Sterile nasopharyngeal swabs (25)
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Dropper caps (25)
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Package insert (1)
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Quick Reference Guide (1)
MATERIALS NOT SUPPLIED
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MARK-B™ 1 analyzer (Model# MB-100)
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System check cartridge (for use with MARK-B™ 1 analyzer)
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Barcode scanner
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Printer
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MARK-B™ COVID-19 Ag Control Solutions (Model# ID032512-CST)
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Any necessary personal protective equipment
How to test 'MARK-B™ COVID-19 Ag'
