COVID-19 antigen test kit | BBB

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

*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

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

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'

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