TB-LAMP Detect TB. Accurately. Easily.

Product Features

• TB- LAMP is a molecular diagnostic technique, used for the diagnosis of Pulmonary Tuberculosis, using sputum as the sample. The product was developed by Eiken, Japan and has undergone clinical trials in more than 22 countries, including India. WHO approved the product in August 2016, and endorsed it as a potential replacement for Sputum Smear Microscopy (SSM). The trial in India (WHO-FIND) was done at PGIMER, Chandigarh and MGIMS, Sevagram, Wardha, which was conducted at the DMC level and sustained Indian conditions of temperature and Humidity, where most of the other molecular diagnostics tests find limitations. Noteworthy is the fact that TB LAMP was also included in the first Essential Diagnostics List published by WHO in June 2018, as a TB diagnostic test, especially for the peripheral centers. 
• Eiken partnered with Human GmbH of Germany for worldwide marketing of the product and Human appointed Nextgen Invitro Diagnostics Ltd (NGIVD) as the exclusive marketing partner for India. NGIVD has already made proposals to Central Tuberculosis Division (CTD) for inclusion in the RNTCP program and also conducted an additional study in India as suggested by ICMR, at AIIMS, Delhi, and PGIMER, Chandigarh for the specificity of the test. In this study, TB LAMP achieved an average specificity of more than 96% (which is equivalent to GeneXpert). NGIVD has already received the approval from ICMR to commercialize the test in India in the Private market, 
  WHO FIND clinical trials which were conducted by FIND across 22 countries, with Indian sites being MGIMS, Wardha and PGIMER, Chandigarh and subsequent approval by WHO in August 2016 as a potential replacement for Sputum Smear Microscopy.
• Subsequent studies performed by PGIMER, Chandigarh in 2017, which demonstrated 100% sensitivity and 99.2% specificity and was also published in INT J TUBERC LUNG DIS 21(10): 1150-1153
• Other Disease control study, as recommended by the ICMR Expert Committee, conducted at AIIMS, Delhi and PGIMER, Chandigarh, demonstrated 96% specificity for True TB negative cases on a total sample population of 216
• Inclusion of TB LAMP in WHO Essential Diagnostics List published in July 2018
• Inclusion of TB LAMP in Global Drug Facility under the StopTB Partnership program
• Adoption of TB LAMP in the National TB program in Other Countries
• In addition, TB LAMP has several advantages over any of the existing tests which are approved for detection of TB suspects in India:
• Raw Sputum is directly used as sample without any processing
• High sensitivity (>97%) and specificity (>96%)
• The LAMP technology provides better results than microscopy, detecting 15% more patients with pulmonary TB when used for all persons presenting with signs or symptoms of TB
• When used as an add-on test after microscopy, the increase in TB cases detected among those with smear-negative results is more than 40%
• High-throughput – 14 samples in 1.5 hours, and achieves a thru-put of 60-70 samples in a single shift of 8 hours
• The test does not require sophisticated instrumentation and has biosafety requirements similar to Smear Microscopy
• Is a very simple technique, can be performed by a minimal trained technician
• Visible detection of positive samples (through fluorescence), thereby making it easy to read the output of the test
• No cold chain requirement and can be performed in room temperature conditions.
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