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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
*The MARK-B™ 1 analyzer(MB-100) and the MARK-B™ COVID-19 Ag are CE marked.
Benefits : COVID-19 antigen test
Deliver lab-quality results in 15 mins.
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 94.4%
specificity 100.0%
The clinical performance of MARK-B™ COVID-19 Ag was established with a study using NPS specimens, which have been previously characterized and were supplied by a biorepository in the United States. In the clinical performance, seventy-two (72) samples were measured, resulting in a sensitivity of 94.4% (34/36) and a specificity of 100.0% (36/36).
Enable the physician to verify infection quickly, begin proper treatment and to initiate isolation precautions helping prevent further spread of infection.
Accuracy
Limit of Detection
2.39 x 10 TCID /mL
1
50
Detect a positive result against the low concentration sample without amplification before any symptom onset.
*The MARK-B™ COVID-19 Ag test cartridge. It's disposable.
Specification
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Direct sample types include: Nasopharyngeal swabs
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Simple operation via visual touchscreen
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Assay kit contains all necessary components for testing to include: 25 test cartridges, swabs for sample collection, reagent solution kits
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Actionable results in 15 minutes or less
Benefits : MARK-B™ 1 analyzer
Every infectious disease test needs quick answers. That’s why you need MARK-B™ 1 analyzer; a high-performance immunoassay analyzer that provides accurate results in minutes, not hours.
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Easy to learn and use only minimal training requirements
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Small footprint saves you bench space
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Can be used in any healthcare setting
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Large visual touchscreen displays results
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Eliminating transcription errors and the need for printing
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No need for calibration
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Facilitates effective patient management
*The MARK-B™ 1 analyzer(MB-100) is CE marked.
How to use 'MARK-B™ COVID-19 Ag'
Helpful documents
MARK-B™ 1 analyzer User Manual
IFU for MARK-B™ COVID-19 Ag
Quick Reference guide for MARK-B™ COVID-19 Ag
[MARK-B™ COVID-19 Ag]Fact Sheet for HCP
[MARK-B™ COVID-19 Ag]Fact Sheet for Patients
