Harnessing the advantages of TB-LAMP in
India’s private healthcare sector
Dr. Shalabh Malik, MD
National Head Microbiology & Molecular Department

Dr. Lal PathLabs
Where Quality, Service, Innovation is a way of life

Undisputable Leaders in Diagnostics•

One of the largest and most respected diagnostic service
provider in the country•

Backed by a proven track record of over six decades for strict
adherence to international standards and benchmarks•Over 200 state-of-the-art laboratories, over 2600 collection
centers and over 6400+ pickup points across India•

Offering the widest test menu of 4600 + tests & Panels•Over 18 million customers every yearLeveraging the advantages•World-class Quality–Accredited by College of American Pathologists (CAP),
National Accreditation Board for Testing andCalibration Laboratories (NABL), ISO 9001: 2008

certification from British Standards Institution (BSI),
Centre for Disease Control (CDC), Atlanta, Georgia,
USA•

State-of-the-art technology and highly skilled
personnel•

Quick Turnaround Time

India is the highest TB burden country accounting for more than one-fourth of theglobal incidence•The estimated TB incidence inIndia
27%India is 2.7 million•

Other countries20%

In 2018, RNTCP was able toachieve a notification of 2.1

Other 13 HBCs
16%

million•Of the total notification, 25%(0.54 Million) cases were fromthe private sector•

TB HIV co-infection rate of 3.4%

Phillipines
3%
Pakistan
3%
Ethiopia3%

Indonesia
6%
Nigeria
5%
Bangladesh South Africa
5%
4%

China
11%

High Yielding Facts•

WHO FIND clinical trials were conducted by FIND across 22 countries•Inclusion of TB-LAMP in WHO Essential Diagnostics List published in July 2018•

Inclusion of TB-LAMP in Global Drug Facility under the Stop TB Partnership program•High sensitivity (94 - 100%) and specificity (99%)•When used as an add-on test after microscopy, the increase in TB cases detectedamong those with smear-negative results is more than 60%

TB-LAMP test performed on pulmonary samples during
March to September 2019400

312300Total no200

Positive

62100

19,9% of Positive

0TB-LAMPTB-LAMP detected additional 10% more positive cases than SSM

Experience at Dr. Lal PathLabs•Test has been launched six months ago post 100% accuracy and precision testing•

Most economic and fastest molecular test•

Possible with minimum sample volume esp. in case of EPTB – 60-100 µL•

Economical in terms of capex and consumables

Experience at Dr. Lal PathLabs•

No heavy infrastructure or biosafety requirements•

Amplified DNA in surplus to enable naked eye detection•

Have expanded it’s horizon by combining it with multiplex in Biofire panels•

Fast adoption due to simplicity and low training requirement•

Efficient QC support from the company

Areas of improvement•

Does not cover the Govt. approach that all positive TB cases should be tested for theirrifampicin status•

Difficulties of TB-LAMP to detect MTB in samples with very low MTB content(Ct value 30 to 35)•Increasing awareness for the advantages of TB-LAMP and stronger penetration ofperipheral health centers are needed•

For a broader expansion, automation, electronic result reporting and a better price pertest would be desirable

New Test Panels•

Creating new Test panel to include TB-LAMP with Bio Fire•

More panels to follow soon

Thank you for your attention