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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
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:
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MNPs conjugated with monoclonal antibodies specific for nucleocapsid proteins from SARS-CoV-2
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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:
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MARK-B™ COVID-19 Ag (25) : test cartridges with monoclonal anti-SARS-CoV-2 antibodies, MNPs, and electrochemical sensors
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Reagent Tubes (25): solutions for collecting specimens
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Sterile nasopharyngeal swabs (25) : flexible swabs for collecting specimens
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Package insert (1)
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Quick Reference Guide (1)
REAGENTS AND MATERIALS SUPPLIED
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MARK-B™ 1 analyzer
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Adapter
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Power cord
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Barcode scanner
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Printer
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Negative Control Solution
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Positive Control Solution
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A pipette and disposable tips to transfer the specimen (or a glass capillary)
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A vortex shaker (or a mixer)
WARNINGS AND PRECAUTIONS
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Only use MARK-B™ COVID-19 Ag test cartridges with the MARK-B™ 1 analyzer.
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Do not use expired MARK-B™ COVID-19 Ag test cartridges.
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Do not use MARK-B™ COVID-19 Ag test cartridges that are damaged or broken.
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The recommended measurement temperature range is 15-30°C (59-86°F).
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Only use the MARK-B™ COVID-19 Ag test cartridges after a full system check according to the MARK-B™ 1 analyzer user manual.
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Wear disposable protective gloves when handling the MARK-B™ COVID-19 Ag test cartridges and human specimens.
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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.
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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.
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The product is for single use only. Do not re-use.
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Place the test cartridge on the tray with the labelled side facing up.
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Aluminium tapes have been attached on the top of cartridges to help sustain the quality of the cartridges. Only remove these tapes upon usage.
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Take a precise amount of sample for each test and insert it into the sample inlet at once.
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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.
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Do not swallow or damage the MARK-B™ COVID-19 Ag test cartridge.
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The product is for in vitro diagnostics.
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The product is indicated for use in clinical laboratories.
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Follow safety procedures set by your institution for working with chemicals and handling biological specimens.
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This test has not been FDA-cleared or -approved. The test has been validated, but FDA’s independent review of this validation is pending.
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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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