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TB LAMP Application Examples
TB-LAMP - Smear Microscopy Alternative for Resource-Limited Settings
Developed by Eiken Chemical Co., Ltd., TB-LAMP is a cost-effective molecular diagnostic tool designed for high-throughput and rapid detection of TB (tuberculosis). It demonstrates higher sensitivity than smear microscopy and significantly reduces turnaround time, enabling same-day diagnosis and treatment initiation. The system is robust, user-friendly, and suitable for use in settings with minimal laboratory infrastructure. TB-LAMP plays a vital role in identifying cases that are often missed in challenging environments, contributing significantly to improved case detection in underserved populations.
WHO Recommends TB-LAMP for Adult Pulmonary TB Diagnosis
“Loop-mediated isothermal amplification (LAMP) is a unique, temperature-independent technique for amplifying DNA that is simple to use, providing a visual display that is easy to read; additionally, the technique is robust and can be used at peripheral health centers, where microscopy is performed.”
WHO Policy Guidance Loop-Mediated Isothermal Amplification (TB-LAMP) , Nov.2016 >
TB-LAMP - Superior Detection Accuracy for TB Compared to Smear Microscopy
| Source | Sample number | Method | Sensitivity | Specificity |
|
Odume B et al. (2021)¹ |
2,636 | TB-LAMP | 76.7 | 99.3 |
| Smear microscopy | 54.3 | 99.8 | ||
| Reddy et al. (2018)² | 705 | TB-LAMP | 72.6 | 96.8 |
| Smear microscopy | 45.4 | 99.0 | ||
| Donfack et al. (2018)³ | 527 | TB-LAMP | 82.6 | 96.0 |
| Smear microscopy | 53.6 | 99.0 | ||
| N'guessan et al. (2016)⁴ | 429 | TB-LAMP | 92.0 | 94.0 |
| Smear microscopy | 86.0 | 96.0 | ||
| Gray et al. (2016)⁵ | 1,777 | TB-LAMP | 97.2 | 96.6 |
| Smear microscopy | 63.8 | - | ||
| Kaku et al. (2016)⁶ | 472 | TB-LAMP | 99.1 | 98.4 |
| Bojang et al. (2016)⁷ | 261 | TB-LAMP | 100.0 | 100.0 |
| Ou et al. (2014)⁸ | 1,392 | TB-LAMP | 92.1 | 98.3 |
A Sustainable and Field-Ready Diagnostic Solution for Tuberculosis
TB-LAMP is a robust, cost-effective molecular diagnostic method designed for resource-limited settings.
Rapid and High-Throughput Testing
・Delivers results in under 1.5 hours
・Capable of processing up to 14 samples simultaneously
・Up to 70 samples can be tested per day
・Enables same-day diagnosis and treatment initiation, improving patient outcomes and programmatic efficiency
Cost-Effective
The approximate cost per test is ＄6 when procured through the Global Drug Facility (GDF).
GDF LOOPAMP™(LAMP) Technical Information, Mar. 2020＞
GDF Medical Devices & Other Health Product Catalog, Aug. 2025＞
Highly Adaptable for Field Use
・Reagents are stable at room temperature; no cold chain required.
・Compact, durable equipment suitable for peripheral laboratories.
・Operates using an external battery, which can be charged via a portable solar panel provided by the manufacturer.
Simple and User-Friendly
・Visual readout eliminates the need for complex instrumentation.
・Can be performed by laboratory staff with no prior molecular testing experience.
・Only two days of training required for implementation.
TB-LAMP Operation >
Sustainable Support and Supply System
Through our partnership with HUMAN Gesellschaft für Biochemica und Diagnostica mbH, the distributor of TB-LAMP, we ensure sustainable supply and flexible local support. On-site training by local experts is also available to support long-term implementation.
・The local TB-LAMP agent responds quickly to technical issues, providing immediate support via WhatsApp.
・For more complex issues, step-by-step guidance is offered through video calls.
・When repairs are needed, replacement devices are shipped, and the faulty units are collected and repaired.
・TB-LAMP users and country-level teams maintain a strong, collaborative relationship with the local agent.
Services >
Examples of using TB LAMP
Case of Nigeria
A practical pilot study conducted by KNCV TB Foundation Nigeria demonstrated the effectiveness of TB-LAMP as an alternative to smear microscopy in high TB burden settings, including areas with significant TB/HIV co-infection and drug-resistant TB (DR-TB)¹.
The study found that TB-LAMP provides high diagnostic accuracy for pulmonary TB (PTB) in adults and can serve as a suitable replacement for smear microscopy. Among adults living with HIV, the performance of TB-LAMP was comparable to both smear microscopy and the Xpert MTB/RIF assay.Based on the evidence generated from this pilot, TB-LAMP has been integrated into routine TB testing in Nigeria. Since the project started in 2020, over 100,000 TB cases have been detected.In line with the national TB diagnostic algorithm, TB-LAMP is used as an initial test for PTB. Individuals with a positive TB-LAMP result are subsequently tested with GeneXpert to detect drug resistance.
Active Case Finding using Wellness of Keke (Wok)⁹
KNCV TB Foundation Nigeria has played a leading role in introducing TB-LAMP testing in Nigeria. As part of this effort, the “Wellness on Keke” (WOK) initiative deploys motorized tricycles equipped with TB-LAMP instruments and solar-powered battery systems to deliver essential health services—including on-site TB screening (using TB-LAMP and artificial intelligence-assisted chest X-ray), chronic disease screening, and COVID-19 vaccination—to populations in underserved and hard-to-reach areas. The TB-LAMP device is fully solar-powered, enhancing its utility in settings with limited infrastructure. In comparative operational research conducted by KNCV, TB-LAMP demonstrated higher throughput than Truenat MTB Plus and MTB-RIF Dx, making it better suited for high-volume testing scenarios. While Truenat offers the capability for on-site rifampicin resistance detection, same-day reporting was not consistently feasible in large-scale field use. When operated at full capacity (14 samples per batch), TB-LAMP was also found to be more cost-effective, with a per-test cost of USD 6.00 compared to USD 7.90 for Truenat.
FROM PILOT TO SCALE: KNCV NIGERIA EXPERIENCE IN TB LAMP IMPLEMENTATION IN NIGERIA
By Dr. Bethrand Odume (Executive Director, KNCV Tuberculosis Foundation Nigeria)
SUCCESSFUL TB CASE DETECTION IN NIGERIA WITH TB-LAMP＞
By HUMAN Gesellschaft für Biochemica und Diagnostica mbH
Case of Cameroon
“TB-LAMP in Cameroon: Two Years After – Results and Lessons Learned” by DONKENG DONFACK Valerie Flore (PhD). Centre Pasteur du Cameroun, (Mycobacteriology unit, NRL-TB, NTP)
World TB Day - Special video "TB-LAMP A new tool to improve Tuberculosis diagnosis in Cameroon"
Case of Zambia
“Evaluation and piloting of TB LAMP assay for the diagnosis of PTB in Lusaka” by Eddie Samuneti Solo(BSC, MPH)
Case of the Philippines
“From Research to Policy to Implementation: The TB-LAMP Experience in The Philippines” by Rosarie Villabito Gabuya, MHSS, RN. Department of Health, Research Institute for Tropical Medicine, National Tuberculosis Reference Laboratory
Case of India
“Harnessing the advantages of TB-LAMP in India’s private healthcare sector” by Dr. Shalabh Malik, MD National Head Microbiology & Molecular Department
“TB -LAMP: New validation study and its importance to find the “missing millions” by Dr. Sunil Sethi, Professor, Department of Medical Microbiology. Post Graduate Institute of Medical Education & Research, Chandigarh
Our Global Partnership
HUMAN Gesellschaft für Biochemica und Diagnostica mbH serves as the global distributor of TB-LAMP. Through this partnership, the product and related services are made readily available to healthcare providers and institutions worldwide.
HUMAN Gesellschaft für Biochemica und Diagnostica mbH
Max-Planck-Ring 21, 65205 Wiesbaden, Germany
Web site: HUMAN Diagnostics Worldwide | In Vitro Diagnostic Healthcare Company
Tel: +49 6122 9988-0
Email: info@human.de
Find more information
HUMAN Gesellschaft für Biochemica und Diagnostica mbH>
Stop TB Partnership “TB-LAMP Implementation Experiences & Lessons Learned”＞
Product Information
| Code No. | Product Name | Unit | Storage | IFU |
|---|---|---|---|---|
|
972000 |
Loopamp™ MTBC Detection Kit |
96 tests |
2 – 30°C |
IFU page > |
|
970000 |
Loopamp™ PURE DNA Extraction Kit |
90 tests |
2 – 30°C |
|
|
971000 |
Pipette-60 Set |
384 tips |
1 – 30°C |
PDF > |
If you have any question about using TB products, please refer to FAQ about TB LAMP. *This link will direct you to a website of HUMAN Gesellschaft für Biochemica und Diagnostica mbH (our distributor of TB products) .
Reference
1. Odume B et al. (2021)Diagnostic Accuracy of TB-LAMP for Diagnosis of Pulmonary Tuberculosis among Adult Presumptive TB in Nigeria. Greener Journal of Medical Sciences, 11(2), 122-129.
2.Reddy S. et al. (2017) Detecting Mycobacterium tuberculosis using the loop-mediated isothermal amplification test in South Africa. INT J TUBERC LUNG DIS 21(10):1154–1160.
3.Donfack VFD. et al. (2018) Comparative study of LoopampTM Mycobacterium tuberculosis Complex Kit for Rapid Detection of Mycobacterium tuberculosis Complex in Cameroon. Biomed Biotechnol Res J 2018;2:46-52.
4.N’guessan K. et al. (2016) Clinical Performances of Pure TB-Lamp Kit for M. tuberculosis Complex Detection in Sputum Samples. Journal of Tuberculosis Research, 2016, 5, 129-138.
5. Gray CM. et al. (2016) Feasibility and operational performance of TB LAMP in decentralized setting. J Clin Microbiol; JCM-03036.
6.Kaku T. et al. (2016) Accuracy of LAMP-TB Method for Diagnosing Tuberculosis in Haiti. Jap J Infect Dis; 69(6): 488 – 492.
7. Bojang AL. et al. (2016) Comparison of TB-LAMP, GeneXpert MTB/RIF and culture for diagnosis of pulmonary tuberculosis in The Gambia. J Infect; 72(3): 332 – 33.
8.Ou X. et al. (2014) Diagnostic accuracy of the PURE-LAMP test for pulmonary tuberculosis at the country-level laboratory in China. PLoS One; (5): e94544
9. Stop TB Partnership “Implementation Experiences and lessons learned” Nigeria