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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

*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.

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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.

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*The MARK-B COVID-19 Ag test cartridge. It's disposable.

Specification

  • Direct sample types include: Nasopharyngeal swabs

  • Simple operation via visual touchscreen

  • Assay kit contains all necessary components for testing to include: 25 test cartridges, swabs for sample collection, reagent solution kits
  • Actionable results in 15 minutes or less

REAGENTS AND MATERIALS SUPPLIED

REAGENTS AND MATERIALS SUPPLIED

Principal Ingredients and Amounts Each test cartridge of the MARK-B™ COVID-19 Ag contains the main reactants and components shown below: 

  • MNPs conjugated with monoclonal antibodies specific for nucleocapsid proteins from SARS-CoV-2

  • Electrodes coated with monoclonal antibodies specific for the nucleocapsid proteins from SARS-CoV-2

Product Package Components

 

25 test cartridges of MARK-B™ COVID-19 Ag are provided in the package, which can be used to analyze up to 25 samples, including the control solutions provided in the package.

The package contains the following: 

  • MARK-B™ COVID-19 Ag (25) : test cartridges with monoclonal anti-SARS-CoV-2 antibodies, MNPs, and electrochemical sensors

  • Reagent Tubes (25): solutions for collecting specimens

  • Sterile nasopharyngeal swabs (25) : flexible swabs for collecting specimens

  • Package insert (1)

  • Quick Reference Guide (1)

REAGENTS AND MATERIALS SUPPLIED

  • MARK-B™ 1 analyzer

  • Adapter

  • Power cord

  • Barcode scanner

  • Printer

  • Negative Control Solution

  • Positive Control Solution

  • A pipette and disposable tips to transfer the specimen (or a glass capillary)

  • A vortex shaker (or a mixer)

WARNINGS AND PRECAUTIONS

  • Only use MARK-B™ COVID-19 Ag test cartridges with the MARK-B™ 1 analyzer.

  • Do not use expired MARK-B™ COVID-19 Ag test cartridges.

  • Do not use MARK-B™ COVID-19 Ag test cartridges that are damaged or broken.

  • The recommended measurement temperature range is 15-30°C (59-86°F).

  • Only use the MARK-B™ COVID-19 Ag test cartridges after a full system check according to the MARK-B™ 1 analyzer user manual.

  • Wear disposable protective gloves when handling the MARK-B™ COVID-19 Ag test cartridges and human specimens.

  • Take a precise amount of sample (in the case of using the reagent solution tube, insert 3 - 4 drops; in the case of using the micropipette, draw 100 μL) for each test and insert it into the sample inlet at once.

  •  Gently press the MARK-B™ COVID-19 Ag test cartridge down onto the tray of the MARK-B™ 1 analyzer until it will go no further. 

  • The product is for single use only. Do not re-use.

  • Place the test cartridge on the tray with the labelled side facing up.

  •  Aluminium tapes have been attached on the top of cartridges to help sustain the quality of the cartridges. Only remove these tapes upon usage.

  • Take a precise amount of sample for each test and insert it into the sample inlet at once.

  • Discard the MARK-B™ COVID-19 Ag test cartridge after use as required by internal quality control procedures and in accordance with local, state and federal regulations or accreditation requirements.

  • Do not swallow or damage the MARK-B™ COVID-19 Ag test cartridge.

  • The product is for in vitro diagnostics.

  • The product is indicated for use in clinical laboratories.

  • Follow safety procedures set by your institution for working with chemicals and handling biological specimens.

  • This test has not been FDA-cleared or -approved. The test has been validated, but FDA’s independent review of this validation is pending.

  • This test has been validated only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens.

How to test '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

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