laboratory at NTI has been designated as a National Reference Laboratory (NRL)
under the National Tuberculosis Elimination Program (NTEP). Three states viz
Karnataka, Maharashtra and Rajasthan have been allocated to the National
Reference laboratory at NTI, Bangalore for the purpose of quality assurance
in sputum smear microscopy and culture & drug susceptibility testing (CDST).
Technical Support to Central TB Division:
data collected from the states, assess the performance and gives feedback
to CTD for effective implementation of NTEP.
As a member of
the National Lab Committee, provides technical
expertise various diagnostic tools used in Mycobacteriology and on External Quality Assessment of sputum smear microscopy.
By carrying out
External Quality assurance of sputum smear microscopy through on site
evaluation of the state level laboratories.
Culture and DST by Solid / Liquid culture / Molecular methods.
Diagnosis of Drug
Resistant Tuberculosis for the states which are in the process of
certification for Culture & DST Laboratory.
Extensively Drug Resistant Tuberculosis by doing 2nd line DST for
the states supervised by the NTI.
National data on the prevalence of drug resistance among new and previously
treated cases of tuberculosis by undertaking periodic drug resistance
A nodal centre
for training Laboratory personnel and Programme Managers in
Assessment of sputum smear microscopy
Culture and Drug
Susceptibility testing for detection of Drug Resistant Tuberculosis by Solid
(Lowenstein Jensen) and Liquid Culture (MGIT 960).
Training in Geno
Type MTBDR Plus assay, Line Probe Assay 1st and 2nd
Maintenance and Minor Repairs of the Binocular Microscope and also
Facilitates for the Laboratory component in the NTEP Modular Training.
supervise and monitor the External Quality Assessment of sputum smear
microscopy in the states allocated to NTI by:
On-Site Evaluation (OSE) of IRLs as per guidelines
the recommendations made by the state EQA team during their visit to the
the quality of OSEs performed by the IRLs to the districts.
panel testing for IRL Microbiologists and Lab technicians.
the Random Blinded Re-checking activities conducted by the DTOs.
Support to States:
proficiency testing for accreditation of state level laboratories i.e.
the Intermediate Reference Laboratories, Medical College laboratories
and other private laboratories for the culture and drug susceptibility
test by solid culture (Lowenstein Jensen), Liquid culture (MGIT 960) and
Molecular techniques such as Line Probe assay and CBNAAT.
the annual Proficiency testing in Liquid Culture for Extended Second
Line DST and in 1st and 2nd Line DST in Line Probe
Assay and in CBNAAT.
technical support to WHO, UNION and SAARC countries:
organizing and conducting training programmes in the Quality Assurance
for sputum smear microscopy, Culture & Drug Susceptibility testing
for the SAARC countries
LED FM and Operational Research workshops for the UNION
AVAILABLE AT LABORATORY DIVISION, NTI :
Smear Microscopy Services:
Culture and DST Services:
Culture, Identification and DST (MGIT 960 Automated System):
samples which are processed by the NALC NaOH method alone can be
utilized for liquid culture. Both MDRTB & XDRTB diagnosis are
being performed by testing the culture isolates against first line and
second line drugs.
are confirmed to be Mycobacterium tuberculosis using an
by the proportion method for first Line Drugs Viz.
Pyrazinamide, Rifampicin, and Isoniazid and second line drugs
such as Levofloxacin, Moxifloxacin, Linezolid, Amikacin, are routinely
being performed at NTI Laboratory.
Culture, Identification and DST (LJ Medium):
samples are processed using the NALC-NaOH method for homogenization
and decontamination. The centrifuged deposit is inoculated onto
Lowenstein Jensen medium and incubated at 37 Deg C for growth up to 8
isolate is confirmed to be Mycobacterium tuberculosis by
performing biochemical tests such as Niacin Production, Nitrate
Reductase test and no growth on
Para nitro Benzoic acid containing media.
Susceptibility testing by the Proportion sensitivity method is
routinely being performed. The isolates testing against first line
drugs such as, Isoniazid, Rifampicin, Pyrazinamide and Second line
agents such as Fluoroquinolones, second line injectable, Linezolid
etc, is available for DRTB diagnosis for proficiency testing purposes.
Molecular Tests for Drug Resistance Detection:
MTBDR plus test
- Line Probe Assay (LPA):
detection of MDRTB can be performed by the Line Probe Assay.
Genotype MTBDR plus test is based on the DNA STRIP technology and
permits the molecular genetic identification of the M.
tuberculosis complex and its resistance to rifampicin or isoniazid
from culture isolates or directly from smear positive pulmonary sputum
identification of rifampicin resistance is enabled by the detection of
the most significant mutations of the rpo B gene. For testing high
level of isoniazid resistance the kat G gene is examined and for
testing low level isoniazid resistance the inh A gene is examined.
GenoType MTBDRsl version
2.0-line probe is used for molecular detection of
resistance-conferring mutations of fluoroquinolones (FLQ) (gyrA and gyrB genes)
and second-line injectable drugs (SLID) (rrs and eis genes).
The test is performed only on smear positive samples.
based Nucleic Acid Amplification Test (CBNAAT) Gene Xpert:
an automated Nucleic Acid Amplification test (NAAT) that is specific
for TB and detects resistance to Rifampicin through the rpoB gene on
both smear positive and smear negative sputum samples is also being
used for MDRTB diagnosis.
is rapid, closed, isothermal system using multiple primers. This test
is particularly useful while screening diagnostic cases that are sero-positive
for HIV infection and /or are smear negative with radiological signs
of pulmonary TB.
process of Manufacturing and validating the Dried Tube specimen for
EQA Panels involves: Culturing the Mycobacterial strain in Liquid
Culture system followed by inactivation of the cultures using sample
reagents. Further incubating for 84 days for confirmation of
inactivation followed by Preparation of Dried Tube Specimens panel
cultures and its validation. Once
validated, the DTS panels are ready to be dispatched to the CBNAAT
sites. Each site would receive a set of 5 tubes/machine.
conducted National Drug Resistance Survey (NDRS) in 2014-2016 for
determining drug resistance patterns in sputum samples received from all
states of the country
Laboratory is one of the nodal centre for National Prevalence Survey for
TB in the state of Karnataka. The samples received from the various
clusters is processed and analysed for its anti-tubercular drug resistance
Laboratory is also one of the nodal centre for the Sero-surveillance for
Covid 19 samples in the state of Karnataka.
NRL and ICELT has manufactured, validated Dried tube specimen panels for CBNAAT
EQA and has initiated EQA for CBNAAT sites in the country.