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The EZER™ TB MPT64 Antigen Rapid Test is a qualitative immunochromatographic assay for the detection of MPT64 protein, a secretory antigen expressed by the Mycobacterium tuberculosis complex (MTBC). It provides a rapid and accurate method to identify key MTBC species—M. tuberculosis, M. bovis, M. africanum, and M. microti—directly from culture samples.
Designed for professional laboratory use, this in vitro test enables early confirmation of TB complex in solid or liquid media within just 15 minutes. It uses highly specific monoclonal antibodies against MPT64, conjugated to colloidal gold for visual detection.
The MPT64-positive test provides strong visual lines for both test and control indicators and demonstrates 100% sensitivity, specificity, and total agreement compared to the reference standard Abbott Bioline™ MPT64 antigen test. The assay eliminates the need for PCR or molecular diagnostics in confirmation steps.
Whether in resource-rich or resource-limited settings, the EZER™ TB MPT64 test ensures confidence in TB culture confirmation, supports biosafety in laboratories, and contributes to faster diagnosis and patient isolation.
The EZER™ TB MPT64 kit includes:
40 or 20 individual test devices (cassette format)
Sample extraction buffer (available separately)
Product insert and instructions
The device detects the MPT64 antigen via lateral flow technology. A red-purple test line (T) indicates antigen presence, while the control line (C) validates test integrity. Results are reliable within 15–60 minutes.
MPT64 is a protein secreted specifically by organisms in the Mycobacterium tuberculosis complex. Its presence is used as a confirmatory marker for TB after culture growth. MPT64 is not produced by nontuberculous mycobacteria (NTM), making it an ideal diagnostic target.
Detecting MPT64-positive cultures supports:
Rapid distinction between MTBC and NTM
Early decision-making for TB isolation and treatment
Biosafety in lab environments handling Mycobacterium spp.
Improved workflow in TB diagnostics
This assay is especially valuable when integrated into workflows with smear microscopy and culture.
Manufactured by Genesis Biotech, the EZER™ TB MPT64 test is based on immunochromatographic principles using monoclonal anti-MPT64 antibodies labeled with colloidal gold. It does not require instrumentation and is compatible with a wide range of culture media.
Positive Percent Agreement: 100%
Negative Percent Agreement: 100%
Overall Agreement: 100%
Minimum Detection Limit: 1.2 × 10⁶ CFU/mL
M. avium, M. gordonae, M. smegmatis, M. abscessus, M. kansasii, M. fortuitum, M. xenopi, Staphylococcus aureus, and other NTMs.
Test validation involved 187 MGIT culture-positive samples (AFB smear-positive), showing full agreement with Bioline™ TB Ag MPT64.
The test detects MPT64 protein secreted by MTBC from culture media (solid or liquid). It works as follows:
From solid media (e.g., LJ): Pick colonies with a loop, suspend in extraction buffer
From liquid media (e.g., MGIT, Dubos): Mix tube and use 100 µL of culture
Apply 100 µL sample directly to the cassette well
Positive results: Visible in 5–15 minutes
Maximum read window: 60 minutes
Positive: Red lines at C and T
Negative: Line at C only
Invalid: No C line – repeat test
This MPT64-targeted format is ideal for routine TB confirmation and helps reduce diagnostic turnaround time compared to PCR or DNA probe-based methods.
The EZER™ TB MPT64 Antigen Rapid Test is recommended for:
Clinical microbiology and TB reference labs
Hospitals in TB endemic regions
Public health laboratories and DOTS centers
Biosafety-sensitive labs requiring rapid culture confirmation
Its quick time-to-result and 100% diagnostic agreement make it a suitable replacement or complement to molecular confirmation tools in culture-based TB diagnostics.
The test contributes to:
Faster reporting of MPT64-positive TB cultures
Reduced biohazard risks by early identification
Improved workflow in low-resource and high-burden settings
Accurate detection across various MTBC strains (M. tuberculosis, M. bovis, M. africanum, M. microti)
Product Catalogus
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