COVID-19 Antigen Test

Result in 15 minutes 

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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.

Turn-around Time

Accuracy

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

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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.

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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'

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