BackgroundRapid and accurate diagnosis of tuberculosis (TB) is key to manage the disease and to control and prevent its transmission. Many established diagnostic methods suffer from low sensitivity or delay of timely results and are inadequate for rapid detection of Mycobacterium tuberculosis (MTB) in pulmonary and extra-pulmonary clinical samples. This study examined whether a real-time polymerase chain reaction (RT-PCR) assay, with a turn-a-round time of 2 h, would prove effective for routine detection of MTB by clinical microbiology laboratories.MethodsA systematic literature search was performed for publications in any language on the detection of MTB in pathological samples by RT-PCR assay. The following sources were used MEDLINE via PubMed, EMBASE, BIOSIS Citation Index, Web of Science, SCOPUS, ISI Web of Knowledge and Cochrane Infectious Diseases Group Specialised Register, grey literature, World Health Organization and Centres for Disease Control and Prevention websites. Forty-six studies met set inclusion criteria. Generated pooled summary estimates (95% CIs) were calculated for overall accuracy and bivariate meta-regression model was used for meta-analysis.ResultsSummary estimates for pulmonary TB (31 studies) were as follows: sensitivity 0.82 (95% CI 0.81–0.83), specificity 0.99 (95% CI 0.99–0.99), positive likelihood ratio 43.00 (28.23–64.81), negative likelihood ratio 0.16 (0.12–0.20), diagnostic odds ratio 324.26 (95% CI 189.08–556.09) and area under curve 0.99. Summary estimates for extra-pulmonary TB (25 studies) were as follows: sensitivity 0.70 (95% CI 0.67–0.72), specificity 0.99 (95% CI 0.99–0.99), positive likelihood ratio 29.82 (17.86–49.78), negative likelihood ratio 0.33 (0.26–0.42), diagnostic odds ratio 125.20 (95% CI 65.75–238.36) and area under curve 0.96.ConclusionsRT-PCR assay demonstrated a high degree of sensitivity for pulmonary TB and good sensitivity for extra-pulmonary TB. It indicated a high degree of specificity for ruling in TB infection from sampling regimes. This was acceptable, but may better as a rule out add-on diagnostic test. RT-PCR assays demonstrate both a high degree of sensitivity in pulmonary samples and rapidity of detection of 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 registrationPROSPERO CRD42015027534.Electronic supplementary materialThe online version of this article (10.1186/s13643-017-0608-2) contains supplementary material, which is available to authorized users.

Background Tuberculosis (TB) diagnosis in children is a major challenge with up to 94% of children with TB treated empirically in TB high-burden countries. Paediatric tuberculosis (PTB) remains a major cause of morbidity and mortality globally, particularly in developing countries. Most deaths/morbidity from TB in paediatrics could be prevented with early diagnosis and appropriate treatment. The main objective of this systematic review is to examine the evidence whether real-time polymerase chain reaction assay could be the most accurate clinical laboratory diagnostic methodology for the Mycobacterium tuberculosis (MTB) detection in paediatrics. Methods We will search MEDLINE/PubMed, EMBASE, BIOSIS, LILACS, Cochrane Infectious Diseases Group Specialised Register (CIDG SR), Global Health, and CINAHL for published studies that recruited children less than 16 years of age being investigated for Mycobacterium tuberculosis (MTB) infection using real-time polymerase chain reaction assay accompanied by mycobacteriological culture investigation as the reference standard. There will be no restriction regarding the language, date of publication, and publication status. We will include randomised controlled trials and observational studies (cohort, cross-sectional) in the review. Selection of studies, data extraction and management, assessment of risk of bias, and quality of evidence will be performed by two independent reviewers (EB and BC). A third researcher will be consulted in case of discrepancies. Depending on the availability and quality of the data, a meta-analysis will be performed. Otherwise, findings will be qualitatively reported. Discussion To our knowledge, this is the first systematic review and meta-analysis assessing the detection of MTB from all clinical sample types using real-time polymerase chain reaction assay in paediatric population. This review will make available evidence on the accuracy, approach, and interpretation of results of this assay in the context of MTB diagnosis which will meet an urgent need, considering the challenges of MTB diagnosis in paediatrics. Systematic review registration PROSPERO CRD42018104052 Electronic supplementary material The online version of this article (10.1186/s13643-019-1137-y) contains supplementary material, which is available to authorized users.

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

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. Clinical management is especially challenging, and recommendations are based on restricted evidence. Many established diagnostic methods suffer from low sensitivity or delay of timely results and are inadequate for rapid detection of Mycobacterium tuberculosis (MTB) in pulmonary and extra-pulmonary clinical samples. This study assessed the overall accuracy of a real-time polymerase chain reaction (RT-PCR) based assay, with a turn-a-round time of 2 h, 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 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. The following sources were used MEDLINE via PubMed, EMBASE, BIOSIS Citation Index, Web of Science, SCOPUS, ISI Web of Knowledge, World Health Organization and Centres for Disease Control and Prevention websites, Cochrane Infectious Diseases Group Specialised Register, and grey literature. Twenty studies (5,536 specimens) that met set inclusion criteria were included. 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 eligible studies met our inclusion criteria. In total, the review and meta-analysis included 5, 536 (3, 209 PTB and 2, 327 EPTB). Summary estimates for pulmonary TB (11 studies) were as follows: sensitivity 56 (95% CI 51-62), specificity 97 (95% CI 96-98), positive likelihood ratio 70.73 (95% CI 8.55-585.40), negative likelihood ratio 0.43 (0.28-0.66), diagnostic odds ratio 193.06 (95% CI 51.21- 727.83) and summary receiver operating characteristic (SROC) area under curve 0.98. Summary estimates for extra-pulmonary TB (10 studies) were as follows: sensitivity 87 (95% CI 82-91)) specificity 100 (95% CI 99-100), positive likelihood ratio 111.91(53.97-232.04), negative likelihood ratio 0.15 (0.07-0.30), diagnostic odds ratio 1337.84 (95% CI 441.92- 4050.12) and summary receiver operating characteristic (SROC) area under curve 0.99. 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.RT-PCR assay demonstrated a high degree of sensitivity for extra-pulmonary TB and good sensitivity for pulmonary TB. It indicated a high degree of specificity for ruling in TB infection from sampling regimes. This was acceptable but may better as a rule out add-on diagnostic test. RT-PCR based assays demonstrate both a high degree of sensitivity in extra-pulmonary and moderate sensitivity in pulmonary samples and rapidity of detection of 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

BackgroundToxoplasma gondii (T. gondii) infection during pregnancy is associated with a variety of complications to the mother and baby. In Tanzania, there is a paucity of data on exposure T. gondii infection among pregnant women and the associated risk factors. Therefore, this study investigated the seroprevalence of T. gondii and associated factors among pregnant women attending antenatal care in Ilala Municipality, Dar es Salaam.MethodsA cross-sectional study was carried out among 383 pregnant women attending antenatal health care. A five mL of blood sample was collected from each of the recruited pregnant women, processed to obtain serum, and tested for the presence of IgG and IgM anti-T. gondii specific antibodies. A structured questionnaire was used to gather information on the risk factors predisposing pregnant women to the infection. Data analysis was performed using descriptive statistics and logistic regression. ResultsOf the 383 participants, 104 (27.2%) were positive for antibodies specific to T. gondii; 102 (26.63%) were positive only for IgG, and 2 (0.52%) were positive both for IgM and IgG antibodies. Significantly risk factors for T. gondii infection included: increased maternal age (34-39) years [AOR = 3.714, 95% CI:1.522-9.062), eating unwashed fruits [AOR = 7.385, 95% CI:3.994-13.658,], not washing hand with soap after meat preparation [AOR = 7.525, 95% CI:3.403-16.642], consumption of undercooked meat [AOR = 3.746, 95% CI:1.945-7.217], and consumption of raw vegetable [AOR = 1.986, 95% CI:1.038-3.800]. ConclusionsThe seroprevalence of T. gondii infection (27.2%), indicates ongoing transmission hence the need for regular screening during antenatal care and establishment of a control program.