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Updated: Oct 15, 2025
A Tuberculosis Molecular Bacterial Load Assay TB-MBLA
Published on: April 30, 2020
Paediatric tuberculosis diagnosis using Mycobacterium tuberculosis real-time polymerase chain reaction assay: a
Emmanuel Oladipo Babafemi1, Benny P Cherian2, Beatrice Ouma2
1Liverpool John Moores University-City Campus, Liverpool, Merseyside, UK. boladiipo95@yahoo.com.
Insights
Real-time PCR (RT-PCR) accurately diagnoses paediatric tuberculosis (TB) in various samples. This method shows high sensitivity for extra-pulmonary TB and good sensitivity for pulmonary TB, aiding early treatment.
Area of Science:
- Medical Diagnostics
- Microbiology
- Public Health
Background:
- Accurate diagnosis of paediatric tuberculosis (TB) is crucial for disease management and transmission control.
- Non-invasive collection of quality sputum samples from children (<16 years) with suspected pulmonary TB remains a significant challenge.
- Mycobacterial culture is the gold standard but can be slow and difficult in paediatric cases.
Purpose of the Study:
- To assess the diagnostic accuracy of a real-time polymerase chain reaction (RT-PCR)-based assay for paediatric TB.
- To evaluate RT-PCR for detecting Mycobacterium tuberculosis (MTB) in various clinical samples from children.
- To compare RT-PCR performance against mycobacterial culture in clinical microbiology laboratories.
Main Methods:
- A systematic review and meta-analysis were conducted.
- Literature search across 9 databases (MEDLINE, EMBASE, Web of Science) from August 2019 to November 2020.
- Bivariate random-effects meta-analysis model used to calculate pooled sensitivity and specificity (95% CIs) compared to mycobacterial culture.
Main Results:
- Twenty-one studies including 5536 paediatric patients (3209 PTB, 2327 EPTB) were analyzed.
- For pulmonary TB (11 studies): pooled sensitivity was 56% (95% CI 51-62) and specificity was 97% (95% CI 96-98).
- For extra-pulmonary TB (10 studies): pooled sensitivity was 87% (95% CI 82-91) and specificity was 100% (95% CI 99-100). Significant heterogeneity was noted (p < 0.001).
Conclusions:
- RT-PCR assay is a valuable tool for diagnosing paediatric TB in diverse settings.
- The assay demonstrates high sensitivity for extra-pulmonary TB and good sensitivity for pulmonary TB.
- Effective global TB control and patient management rely on early diagnosis and initiation of appropriate anti-tubercular therapy.
Background:
Rapid and accurate diagnosis of paediatric tuberculosis (TB) is key to manage the disease and to control and prevent its transmission. Collection of quality sputum samples without invasion methods from paediatrics (age < 16 years) with presumptive pulmonary tuberculosis (PTB) remains a challenge. Thus, the aim of this meta-analysis was to assess the overall accuracy of a real-time polymerase chain reaction (RT-PCR)-based assay, for routine diagnosis of MTB in different samples from paediatrics with active pulmonary and extra-pulmonary tuberculosis using mycobacterial culture as the gold standard in clinical microbiology laboratories.
Methods:
We conducted a systematic review and meta-analysis to examine the diagnostic test accuracy of RT-PCR based assay for the detection of MTB in paediatric clinical samples. A systematic literature search was performed for publications in any language. MEDLINE via PubMed, EMBASE, and Web of Science were among 9 bibliographic databases searched from August 2019 until November 2020. Bivariate random-effects model of meta-analysis were performed to generate pooled summary estimates (95% CIs) for overall accuracy of RT-PCR based assay compared to mycobacterial culture as the reference standard.
Results:
Of the 1592 candidate studies, twenty-one eligible studies met our inclusion criteria. In total, the review and meta-analysis included 5536 (3209 PTB and 2327 EPTB). Summary estimates for pulmonary TB (11 studies) were as follows: sensitivity 56 (95% CI 51-62), specificity 97 (95% CI 96-98) and summary estimates for extra-pulmonary TB (10 studies) were as follows: sensitivity 87 (95% CI 82-91)) specificity 100 (95% CI 99-100). There was significant heterogeneity in sensitivity and specificity among the enrolled studies (p < 0.001).
Conclusions:
Our results suggested that the RT-PCR based assay could be a useful test for the diagnosis of paediatrics TB with high sensitivity and specificity in low-income/high-burden and upper medium income/low-burden settings. From the study, RT-PCR assay demonstrated a high degree of sensitivity for extra-pulmonary TB and good sensitivity for pulmonary TB which is an important factor in achieving effective global control and for patient management in terms of initiating early and appropriate anti-tubercular therapy.
Systematic Review Registration:
PROSPERO CRD42018104052.
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