TrueNat TB Test

What is the TrueNat TB test?

The TrueNat TB test is a new molecular test that can diagnosis TB in one hour as well as testing for resistance
to the drug rifampicin.

World Health Organisation (WHO) endorses TrueNat test

In December 2019 WHO held a meeting of its Guidelines Development Group. This was to consider the latest
evidence on the use of the Molbio TrueNat MTB/RIF  test as well as the Xpert MTB Ultra.1Guideline
Development Group meeting, 2019, https://www.who.int/tb/areas-of-work/laboratory/en/ The outcomes of the
meeting will be disseminated as updated WHO guidelines by April 2020.

In the meantime WHO has issued a Rapid Communication on the use of Molecular Assays as initial tests for
the diagnosis of tuberculosis and rifampicin resistance.2Rapid Communication: Molecular assays as initial
tests for the diagnosis of tuberculosis and rifampicin resistance, 2020,
https://apps.who.int/iris/handle/10665/330395

Key Findings
The performance of Truenat MTB, MTB Plus and MTB-RIF Dx assays show comparable accuracy to the Xpert
MTB/RIF and the Xpert Ultra for TB detection (Truenat MTB and Truenat MTB Plus) and for sequential
rifampicin resistance detection (Truenat MTB-Rif Dx).

The Truenat MTB and MTB Plus assays also show comparable accuracy to the TB-LAMP assay as replacement
tests for sputum smear microscopy. The data for Truenat MTB-Rif shows similar accuracy to WHO-approved
commercial line probe assays.

Dr Balram Bhargava, the Director General of the Indian Council of Medical Research, said that this endorsement
of the technology by WHO would enable low and middle income countries to procure TrueNat for tuberculosis
diagnosis and Rifampicin resistance, so supporting the elimination of the disease in developing
countries.3WHO endorses tech developed by Indian scientists to detect TB, multi-drug resistant TB, 2020,
https://health.economictimes.indiatimes.com/news/diagnostics/who-endorses-tech-developed-by-indian-
scientists-to-detect-tb-multi-drug-resistant-tb/73298950

WHO also said that the evidence reviewed supported the continued use of Xpert MTB/RIF and Xpert Ultra as
initial diagnostic tests for pulmonary TB in patients of all ages.
Who has developed the TrueNat TB test?
The TrueNat test has been developed by the Indian firm MolBio Diagnostics Pvt Ltd Goa. It’s development has
been funded by Bigtec Labs, India.

What sample is used for the test?

This test for TB uses a sputum sample taken from each patient. Only about 0.5 ml of the sample is required
compared with about 1 ml needed for the American Genexpert machine.

With this test samples can be tested as soon as a patient with symptoms of TB is seen. As the entire set-up is
both battery operated and portable, it can be used at the most basic parts of the health care system. This is
where this test differs from GeneXpert. GeneXpert is most suitable for being used where several tests can be
done at the same time.

The standard smear microscopy test has limitations. It usually finds it difficult to diagnose TB when the
bacterial load is less than 10,000 per millilitre of the sputum sample, giving erroneus negative results for some
patients. 4Mudur, G. S. “One-hour test for TB”,
https://www.telegraphindia.com/india/one-hour-test-for-tb-183556

How does the TrueNat test work?

The test works by the rapid detection of TB bacteria using the
polymerase chain reaction (PCR) technique.

The machine looks for the DNA specific to the TB bacteria. If the
machine detects it, it then uses PCR to copy (amplify) small
segments of DNA and this DNA can then be used in many different
laboratory procedures.

Any resistance to rifampicin (RR) is detected by doing a second

RTPCR (Reverse transcription polymerase chain reaction)

Automated battery operated devices are used for the extraction of

DNA (Trueprep Auto device) amplification (TrueNat MTB chip) and Addition of DNA to TrueNat MTB chip

reading the presence of specific genomic sequences (TrueLab PCR

analyser).
How long does it take to do a test?
It takes about 25 minutes to do the DNA extraction. It takes another 35 minutes to diagnose TB. It takes an
additional one hour for testing for rifampicin resistance.5“Cheaper, indigenous TB test enters final validation
phase”, The Hindu, July 01,2017,
www.thehindu.com/sci-tech/health/cheaper-indigenous-tb-test-enters-final-validation-
phase/article19193085.ece

Genexpert versus TruNat

The Genexpert machine and the TrueNat machine are designed to be used in different circumstances. The
TrueNat machine is more of a point of care machine, which is not fully automated. It is designed for situations
where there may not be electricity and where the need is for one test to be done at a time.

The Genexpert is designed for larger volumes and needs a reliable electricity supply.

“We are not going to replace GeneXpert. We are planning to take Truenat MTB to the
primary health centre level, which cannot be done using GeneXpert as it needs
uninterrupted power supply and air conditioning.
Dr Swaminathan, Director-General of ICMR
How far advanced is the testing of the TrueNat?
A preliminary test in 2013
In a preliminary test carried out on 191 patient samples in 2013, the sensitivity (ability of a test to correctly
identify those with the disease) of TrueNat was found to be over 91% and the specificity (ability of the test to
correctly identify those without the disease) was 100%.6“Rapid diagnosis of Mycobacterium tuberculosis with
Truenat MTB: A Near-Care Approach”, Plos One, 2013,
http://journals.plos.org/ It was concluded that:

“the TrueNat MTB test not only has good sensitivity and specificity for the diagnosis
of TB but also fits the requirements of the resource limited settings. Large studies are
required to obtain better estimates of the TrueNat MTB performance.”

Performance validation & operational feasibility testing

The test then entered the final leg of performance validation and operational feasibility testing by the Indian
Council of Medical Research (ICMR). ICMR planned to take the test to Public Health Centres which currently
use smear samples to test for TB.

“Besides validating the performance, the focus is on operational feasibility in field

settings. We want to see if the machine performs to our satisfaction in hot and humid
conditions and whether the machine can work even in the absence of power, and lab
technicians with minimum training can operate the machine” Dr. N.S.Gomathi Chennai
National Institute for Research in Tuberculosis (NIRT)

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This page was last updated in January 2020.
Author Annabel Kanabus
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References   [ Click to show references ]

Main Author : Annabel

Kanabus

Citation : Kanabus,

Annabel “Information

about Tuberculosis”,

GHE, 2020,

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