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COVID-19 Antigen Test

Result in 10 minutes at the point of care

The MARK-B™ COVID-19 Ag S test is a electrochemical sandwich immunoassay that is used with the MARK-B™ 1 analyzer intended for the qualitative detection of the spike protein antigen from SARS-CoV-2 in nasopharyngeal swab specimens.

The MARK-B™ COVID-19 Antigen Test allows fast diagnosis with results in 10 minutes in a variety of locations such as physicians' offices, urgent care clinics and other POC locations.

Clinical performance

Sensitivity  98.5%

Specificity  98.5%

Turn-around time

Results in 10 minutes

The MARK-B™  1 analyzer offers an easy-to-use interface, customizable settings, flexible workflow and connectivity. The MARK-B™ 1 analyzer removes the operator variability associated with interpreting visually read test results.

 

The tests results are reported automatically on the screen and can be stored in analyze, optionally printed on an external printer.

MARK-B 

COVID-19 Antigen S Test

™ 

Limit of Detection:

TCID   2.4 x10 per mL

50

  • Qualitative detection of SARS-CoV-2 spike proteins

  • Sensitivity 98.5% , Specificity 98.5 %

  • Fast results within 10 mins

  • Specimen : nasopharyngeal swab

  • CE marked.

MARK-B™

Quantitative immunoassay biosensor

to diagnosis cancer, cardiovascular diseases, sepsis, infectious diseases, thyroid disorders and so on.

Easy.

Quick.

Accurate

• Deliver lab-quality results

• Connected to anywhere

• Reduces the complexity

• Shorten time to diagnosis

Fully automated analysis

Once inserted into the instrument, the sample is separated into plasma by our patent technology. 

In succession, the electrochemical analysis process begins.

No need  for pre-processing 

Self-contained consumable

Quick turnaround 10mins

Quantify precisely

by electrochemical method

MARK-B™ utilizes MESIA,

a patented technology of BBB inc.

Published Journal Paper

“MESIA: Magnetic force-assisted electrochemical sandwich immunoassays for quantification of prostate-specific antigen in human serum”

- <Analytica Chimica Acta>, March, 2019

_ PhD. Hyundoo Hwang, Leader of BBB R&D Center

High expandability in test portfolio 

Tumor

AFP    PSA    CEA    CA19-9    CA125

Cardiovascular disease

cTnI   CK-MB   Myoglobin   D-dimer   

hsCRP   NT-proBNP   Galectin-3   ST2

Sepsis

PCT   IL-6   CRP

Infectious diseases

DVNS1   Influenza A&B

Thyroid

TSH   T3   T4

Metabolism

Vitamin D   Ferritin

Alzheimer's disease

β-amyloid    τ protein    NfL

*Not available for sale

*Scheduled to release in 2020

Connectivity!

Cloud server to communicate with MARK-B™ test results

POCT1-A2 protocol,  HL7, FHIR® to communicate with DMS

Android based Analyzer software

Key specification

Assay method

Magnetic Electrochemical Sandwich ImmunoAssay

Sample

Whole blood (50 µL), Heparinized venous whole blood (50 µL), Serum, heparinized plasma (20 µL)

Measuring range

0.1 ~ 25 ng/mL (PSA) **

Operation condition

2℃~30 ℃ 

Storage condition

2℃~30 ℃ 

Display

5.5” HD display, Touch screen

OS

Android 7.0 (Analyzer software), Linux (Server)

Memory capacity

8GB ROM / 1GB RAM / 1,000,000 test results

Wireless LAN

Wi-Fi 2.4GHz (IEEE802.11 b/g/n)

Bluetooth

BT 4.0 (thermal printer)

Port

4 USB ports accessories, 1 USB port for data

Accessories

Thermal printer, barcode scanner ***

**Depends on the analyte

*** Optional

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