D Ji end a Kuma Sha ma e al. The Diagnos ic Yield o CBNAAT o Mic obiological Diagnosis o Pulmona y
Tube culosis in Child en: An Obse a ional S udy a a Te ia y Ca e Cen e. In . J Med. Pha m. Res., 6 (6): 541‐545, 2025
541
In e na ional Jou nal o Medical
and Pha maceu ical Resea ch
Online ISSN-2958-3683 | P in ISSN-2958-3675
F equency: Bi-Mon hly
A ailable online on: h ps://ijmp .in/
O iginal A icle
The Diagnos ic Yield o CBNAAT o Mic obiological Diagnosis o Pulmona y
Tube culosis in Child en: An Obse a ional S udy a a Te ia y Ca e Cen e
D Ji end a Kuma Sha ma1, D B ijmohan Meena2, D Sandeep Rajo ia3
1 Assis an P o esso , Ins i u e o Respi a o y Diseases, SMS Medical College, Jaipu
2 Assis an P o esso , Depa men o Respi a o y Medicine, GMC Ko a
3 Senio Specialis , Depa men o Respi a o y Medicine, Go e nmen Saada Hospi al, Tonk
A B S T R A C T
Co esponding Au ho :
D Sandeep Rajo ia
Senio Specialis , Depa men o
Respi a o y Medicine, Go e nmen
Saada Hospi al, Tonk.
Recei ed: 15-10-2025
Accep ed: 13-11-2025
A ailable online: 18-11-2025
Backg ound: The mic obiological con i ma ion o diagnosis o pulmona y
ube culosis is di icul because paucibacilla y na u e o disease and younge
child en a e unable o do expec o a e. Ca idge based nucleic acid ampli ica ion
es (CBNAAT) is newe es o diagnosis o ube culosis. Howe e , i s ole in he
diagnosis o pulmona y ube culosis in child en is ye o need mo e e idence o
es ablish.
Objec i e: To de e mine he e ec i eness o CBNAAT o mic obiological
diagnosis o pulmona y ube culosis in child en.
Me hods: This was a c oss sec ional obse a ion s udy conduc ed on 132 child en,
aged 6 mon hs o 18 yea s wi h p esump i e pulmona y ube culosis (PPTB) we e
en olled in s udy. A e ob aining in o med pa en al consen , gas ic aspi a e and
spu um/induced spu um om all en olled pa ien s we e sen o di ec smea ,
CBNAAT (Xpe MTB/RIF* assay) and MGIT cul u e. Ches skiag ams, ube culin
sensi i i y es (TST) and CECT ho ax (in selec ed cases) we e also done. The
diagnosis o PPTB was made as pe he e ised na ional ube culosis con ol
p og am (RNTCP). The sensi i i y, speci ici y, posi i e p edic i e alue and
nega i e p edic i e alue we e calcula ed using MGIT cul u e as gold s anda d.
Resul s: The mean age (mon hs) o en olled pa ien s was 77.87 ± 64.39 mon hs.
Ou o 132 child en wi h PPTB, 60 had mic obiologically con i med pulmona y
ube culosis. O e all, 39.4% en olled child en we e posi i e o CBNAAT. GA and
spu um/induced spu um CBNAAT had sensi i i y and speci ici y o 86.67% (95%
CI: 75.83-93.09%) and 100% (95% CI: 94.93-100%) espec i ely as compa ed
cul u e gold s anda d.
Conclusion: CBNAAT can be used o de ini i e diagnosis o pulmona y
ube culosis in child en as his is highly sensi i e and speci ic es in gas ic aspi a e
and spu um/induced spu um.
Copy igh © In e na ional Jou nal o
Medical and Pha maceu ical Resea ch
Keywo ds: CBNAAT, P esump i e Pulmona y Tube culosis, PPTB, Diagnos ic Yield,
Gas ic Aspi a e, Spu um.
INTRODUCTION
Tube culosis is one o mos common ch onic communicable endemic disease caused by mycobac e ium ube culosis
complex. Pedia ic ube culosis is ep esen ing 12% o he global bu den o TB.1 Pedia ic ube culosis has been
ela i ely neglec ed, because mainly challenges in he a ailabili y o e ec i e diagnos ic ools.2
The mic obiological con i ma ion o diagnosis o pulmona y ube culosis is di icul because paucibacilla y na u e o
disease and younge child en a e unable o do expec o a e. Ca idge based nucleic acid ampli ica ion es (CBNAAT) is
newe es o diagnosis o ube culosis. Howe e , i s ole in he diagnosis o pulmona y ube culosis in child en is ye o
need mo e e idence o es ablish i s u ili y in pedia ic ube culosis.3
D Ji end a Kuma Sha ma e al. The Diagnos ic Yield o CBNAAT o Mic obiological Diagnosis o Pulmona y
Tube culosis in Child en: An Obse a ional S udy a a Te ia y Ca e Cen e. In . J Med. Pha m. Res., 6 (6): 541‐545, 2025
542
The p esen s udy was conduc ed o de e mine he e ec i eness o CBNAAT o mic obiological diagnosis o pulmona y
ube culosis in child en.
METHODOLOGY
This was a c oss sec ional obse a ion s udy conduc ed a SMS Medical College, Jaipu om Sep embe 2017 o Augus
2018. Hospi alized 132 child en, aged 6 mon hs o 18 yea s wi h p esump i e pulmona y ube culosis (PPTB) we e
en olled in o he s udy. A e uling ou he all possible di e en ial diagnosis o pulmona y ube culosis, he diagnosis o
PPTB was made on he basis o ecommenda ion o RNTCP and Indian academy o pedia ics. PPTB was diagnosed
when any pa ien had e e (documen ed) and cough (non emi ing) o mo e han wo weeks wi h/wi hou documen ed
weigh loss mo e han 5% in p eceding 3 mon hs wi h/wi hou con ac wi h TB pa ien in 2 yea s.
A e ob aining in o med pa en al consen , he demog aphic and clinical de ails o all en olled child en we e illed in
p edesigned p o o ma and excel shee . All child en wi h PPTB we e subjec ed o Ches x- ay, ube culin sensi i i y es
(TST). CECT ho ax was also done in selec ed pa ien s. As pe RNCTP and IAP ecommenda ions he adiological
inding in ches x- ay is conside ed highly sugges i e o pulmona y ube culosis i any one o mo e o ollowing is/ a e
p esen : Medias inal lymph node enla gemen /Medias inal widening, ib o-ca i a o y lesion and milia y shadows hose
we e no explained by o he diseases.
All en olled pa ien s wi h PPTB we e unde wen gas ic aspi a e (GA) and spu um/induced spu um samples collec ion
o wo consecu i e days.4 The s anda d p o ocol was ollowed du ing collec ion o hese samples. A e p ope labeling
and packing, immedia ely hese samples we e sen o cen al TB labo a o y o SMS Medical College o es ing o AFB
smea mic oscopy, CBNAAT (Xpe MTB/RIF* assay) and BACTEC-MGIT cul u e.5 Resul o CBNNAT a e gene a ed
a e 2 h and epo ed as M. ube culosis - nega i e o posi i e wi h semi-quan i ied bacilla y load as high, medium,
in e media e o low and i he pa hogen is RIF sensi i e o esis an .6 A e ob aining o esul o hese es s, esul s
en e ed in excel shee .
The diagnosis o mic obiologically con i med pulmona y ube culosis was made i any es including AFB smea
mic oscopy, CBNAAT and MGIT cul u e esul is posi i e o mycobac e ium ube culosis and es all PPTB pa ien s
we e diagnosed as non mic obiologically con i med pulmona y ube culosis/clinico- adiologically diagnosed pulmona y
ube culosis.
S a is ical analysis
The s a is ical analysis was pe o med using STATA 11.0 (college s a ion, Texas, USA). Sensi i i y and speci ici y o
CBNAAT we e de e mined by conside ing MGIT cul u e as gold s anda d. The Posi i e p edic i e alues (PPV),
nega i e p edic i e alue (NPV) o CBNAAT we e calcula ed wi h 95 % CI (con idence in e als). A p- alue o <0.05
was conside ed s a is ically signi ican . The sensi i i y, speci ici y, posi i e p edic i e alue and nega i e p edic i e
alue we e calcula ed using MGIT cul u e as gold s anda d.
RESULTS
In his s udy 132 child en (59.8% emale), aged 6 mon hs o 18 yea s (mean age in mon hs: 77.87 ± 64.39) wi h
p esump i e pulmona y ube culosis we e en olled. Ou o 132 s udy subjec s 60(45.5%) child en had mic obiologically
con i med pulmona y ube culosis (PTB) and 72(54.5%) we e diagnosed as mic obiologically nega i e (clinico-
adiological) pulmona y ube culosis (Table 1).
80 (60.6%) child en wi h PPTB we e accina ed wi h BCG. Among mic obiologically con i med PTB 38(63.3%)
child en we e accina ed wi h BCG and 42(58.3%) child en wi h mic obiologically nega i e PTB ecei ed BCG
accina ion (P Value: 0.684). TST was eac i e in eac i e in56.7% o mic obiologically con i med PTB and also
eac i e in 58.3% o mic obiologically nega i e PTB (P= 0.987). Family his o y o TB con ac was ound in 68.3% o
mic obiologically con i med PTB and in 69.5% o mic obiologically nega i e PTB. The adiological inding o ches x-
ay highly sugges i e o PTB was ound in 91.7% o mic obiologically con i med PTB and in 61.1% o
mic obiologically nega i e PTB (P Value=<0.001). O e all 99 (75%) child en wi h PPTB had highly sugges i e
adiological inding in ches x- ay (Table 2)
Ou o 60 child en wi h mic obiologically con i med PTB, 52 (86.7%) child en had CBNAAT posi i e and es 8
child en we e diagnosed as mic obiologically con i med PTB by ei he posi i e AFB smea mic oscopy o MGIT cul u e
(P alue: <0.001).Ou o 132 child en wi h PPTB, 52(39.4%) child en had posi i e CBNAAT esul (Table 3).
The sensi i i y o CBNAAT in spu um/induced spu um and gas ic aspi a e sample was 86.67% %( 95% CI: 75.83-
93.09%). The speci ici y o CBNAAT in spu um/induced spu um and gas ic aspi a e samples was 100 %( 95% CI:
94.93-100%). O e all posi i e p edic i e alues in spu um/induced spu um and gas ic aspi a e sample in e e ence o
Bac ec-MGIT960 cul u e was100 %( 95% CI: 93.12-100%) (Table 4).
D Ji end a Kuma Sha ma e al. The Diagnos ic Yield o CBNAAT o Mic obiological Diagnosis o Pulmona y
Tube culosis in Child en: An Obse a ional S udy a a Te ia y Ca e Cen e. In . J Med. Pha m. Res., 6 (6): 541‐545, 2025
543
Table 1. Demog aphic p o ile o s udy subjec s
To al no o s udy subjec (p esump i e pulmona y TB)
132
Mic obiological diagnosis o he s udy
subjec s
Mic obiologically con i med
pulmona y TB
60(45.5%)
Mic obiologically non con i med
pulmona y TB
72(54.5%)
Age
Mean ± SD (Mon hs)
77.87 ± 64.39
Sex
Male
53(40.2%)
Female
79(59.8%)
Clinical
p esen a ion
Pe sis en non emi ing cough>2 weeks
132(100%
Documen ed e e >2 weeks
132(100%)
Documen ed weigh loss>5% in las 3 mon h
105(79.5%)
Table 2. The clinico adiological cha ac e is ics o s udy subjec s
Cha ac e is ics
Mic obiologically
con i med
pulmona y TB
Mic obiologically non
con i med pulmona y
TB
To al
P Value
Radiological
indings in ches
skiag am highly
sugges i e o
ube culosis
P esen
55(91.7%)
44(61.1%)
99(75%)
<0.001
Absen
5(8.3%)
28(38.9%)
33(25%)
BCG accina ed
38(63.3%)
42(58.3%)
80(60.6%)
0.684
Man oux Tes
(posi i e)
Reac i e
34(56.7%)
42(58.3%)
76(56.6%)
0.987
Non
eac i e
26(43.3%)
30(41.7%)
56(42.4%)
Family his o y o
TB
P esen
41(68.3%)
50(69.5%)
91(68.9%)
0.959
absen
19(31.7)
22(30.5%)
41(31.1%)
Table 3. The s a us o CBNAAT esul among s udy subjec s
S a us o CBNAAT in
spu um/gas ic aspi a e
Mic obiologically
con i med pulmona y
TB
Mic obiologically non
con i med pulmona y
TB
To al
P Value
Any sample
o CBNAAT
Posi i e
52(86.7%)
0
52(39.4%)
<0.001
Nega i e
8(13.3%)
72(100%)
80(60.6%)
Table 4. Sensi i i y, speci ici y and p edic i e alues o CBNAAT in spu um/induced spu um and gas ic aspi a e
sample in e e ence o Bac ec-MGIT960 cul u e.
Sensi i i y
86.67 %( 95% CI: 75.83-93.09%)
Speci ici y
100 %( 95% CI: 94.93-100%)
Posi i e p edic i e alue
100 %( 95% CI: 93.12-100%)
Nega i e p edic i e alue
90 %( 95% CI: 81.49-94.85%)
Diagnos ic accu acy
93.94 %( 95% CI: 88.5-96.9%)
DISCUSSION
This was en olled 132 child en wi h p esump i e PTB. All hese child en we e subjec ed o ube culin skin es (TST. I
e lec s cell-media ed immuni y o mycobac e ium ube culosis h ough a delayed- ype hype sensi i i y eac ion using a
p o ein p ecipi a e o hea -inac i a ed ube cle bacilli (pu i ied p o ein de i a i e [PPD]– ube culin). The TST is one o
use ul me hod o diagnose he LTBI. The TST is adminis e ed by he in ade mal injec ion o 0.1 ml o PPD (5 TU) in o
he ola su ace o he o ea m (Man oux me hod) o p oduce a ansien wheal. The es is in e p e ed a 48–72 hou s by
measu ing he ans e se diame e o he palpable indu a ion. A eac ion o ≥10 mm is conside ed posi i e TST.7
In ou s udy, O e all 76(56.6%) child en wi h PPTB had posi i e TST. Ou o 60 child en wi h mic obiologically
con i med pulmona y ube culosis,34(56.7%) child en had posi i e TST and 42(58.3%) child en wi h mic obiologically
D Ji end a Kuma Sha ma e al. The Diagnos ic Yield o CBNAAT o Mic obiological Diagnosis o Pulmona y
Tube culosis in Child en: An Obse a ional S udy a a Te ia y Ca e Cen e. In . J Med. Pha m. Res., 6 (6): 541‐545, 2025
544
nega i e PTB had posi i e TST(P alue: 0.987). Hea he J. Za e al. pe o med he TST in 196 child en o p esump i e
PTB. They we e ound TST posi i e in 99(57.2%) child en. which is consis en wi h ou s udy.8
The main ou e o mycobac e ium ube culosis in ec ion is ia inhala ion. The ini ia ion o in ec ion occu s when
in ec ed d ople s a e deposi ed in he e minal ai way o al eoli. This leads o localized pa enchymal in lamma ion
known as Ghon ocus. Then he e is sp ead h ough lympha ic essels o he ipsila e al egional lymph nodes. The uppe
lobes d ain o ipsila e al pa a acheal lymph nodes while he emaining lung d ains o he pe ihila lymph nodes. These
pa enchymal ocus and enla ged lymph nodes collec i ely a e known as Ghon complex.9
As he disease p og esses, adjacen enla ge lymph node can comp ess he ai ways ha can esul in obs uc i e a elec asis
o o e in la ion. This is commonly ound on he igh side a he le el o he igh loba b onchus o b onchus
in e medius. Des uc ion and ib osis o lung pa enchyma leads o ac ion b onchiec asis and ca i y o ma ion. This is
called p og essi e pulmona y ube culosis (p og essi e Ghon ocus).10 Ches x ay is s ill a c ucial ool o diagnosis o
pulmona y ube culosis in child en.11 The adiological indings in ches x ay sugges i e o pulmona y ube culosis a e
pe ihila o media inal lymphadenopa hy, ib o ca i a o y lesion and milia y shadows. The ib o-ca i a o y lesions a e
a e in pedia ic pulmona y ube culosis as his is paucibacilla y ube culosis.12
We ound ha 55(91.7%) child en wi h mic obiologically con i med pulmona y TB had highly sugges i e adiological
inding in ches x ay whe eas only 5 child en did no show speci ic adiological inding sugges i e o ube culosis
among mic obiologically con i med TB ( P alue: <0.001). 44(61.1%) child en wi h mic obiologically non con i med
pulmona y TB demons a ed highly sugges i e ches x ay indings o pulmona y ube culosis. In ou s udy he
commones ches x ay inding sugges i e o ube culosis was enla ged hila lymph nodes. 75% child en had hila
lymphadenopa hy on he ches x ay. Righ sided lung (68%) in ol emen was mo e han le sided lung (21%)
in ol emen .
Bolou saz e al we e done e ospec i e s udy on 70 child en wi h clinical, adiological and mic obiologically diagnosed
pulmona y ube culosis. They did ound ha igh lung in ol emen was obse ed in 65% whe eas le lung was in ol ed
in only 23% child en and hila lymph nodes enla gemen was seen in 70% child en on ches x- ay.13
The WHO End TB s a egy endo sed he ea ly diagnosis o TB, highligh ing he need o accessible, accu a e, and apid
diagnos ic es s in esou ce-limi ed se ings. CB-NAAT is p esen ly ecommended by WHO o be used o diagnosis o
TB in child en.14
In he p esen s udy CBNAAT was posi i e in 86.7% child en wi h mic obiologically con i med pulmona y ube culosis
among any sample o spu um/induced spu um o Gas ic aspi a e. Only among eigh pa ien s wi h mic obiologically
con i med pulmona y ube culosis, i was nega i e (P alue: <0.001).The o e all posi i i y o CBNAAT among any
sample o gas ic aspi a e o spu um was 39.4%. Simila s udy was done by dayal e al among 114 child en wi h
p esump i e PTB. The o e all, posi i i y o CBNAAT in hei s udy was 57.9%.15 In ou s udy he o e all sensi i i y o
CBNAAT in any sample (gas ic aspi a e + spu um/induced spu um) was 86.67% bu i was 71.2 % in gas ic aspi a e
alone. The indings o p esen s udy a e conco dan wi h s udy pe o med by singh e al.16 The sensi i i y o CBNAAT is
inc eased by es ing gas ic aspi a e along wi h spu um/IS o pulmona y ube culosis in child en. The o e all speci ici y
o CBNAAT in gas ic aspi a e wi h spu um was 100%. Almos simila esul s ha e epo ed in o he s udy conduc ed by
Habeenzu C e al and hey ound ha CB-NAAT o ha e sensi i i y and speci ici y o 88.4% and 93.9%, espec i ely,
wi h e e ence o cul u e.17 Sekadde MP e al. did simila s udy as alua ion o he Xpe MTB/RIF es o he diagnosis
o childhood pulmona y ube culosis in Uganda. They we e ound ha he Xpe MTB/RIF es had a sensi i i y o
79.4% (95% CI 63.2 - 89.7) and a speci ici y o 96.5% (95% CI 93 – 98.3) in spu um. 18 Finding o s udy conduc ed by
Rei he e al . We e showing he sensi i i y o 68% (95% CI, 50%e82%) and speci ici y o 100% (95% CI, 97%e100%)
in espi a o y specimens.19
CONCLUSION
The indings o ou s udy sugges ha CBNAAT can play an impo an ole in diagnosis o pulmona y TB in child en.
The CBNAAT is one o he mos apid molecula es o diagnosis o pulmona y ube culosis. This es is highly
sensi i e and speci ic in gas ic aspi a e and spu um as well o diagnose pulmona y ube culosis in child en.
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