The application value of GeneXpert MTB/RIF Ultra in the detection of special specimens of tuberculosis / 中国热带医学

@#Abstract: Objective To compare the diagnostic efficacy of the upgraded version of the GeneXpert automated fluorescent quantitative PCR system (GeneXpert MTB/RIF Ultra, GeneXpert Ultra) and the original version of the GeneXpert system (GeneXpert MTB/RIF, Xpert), real-time fluorescent quantitative nucleic acid detection (FQ-PCR), real-time fluorescent thermostatic amplification of Mycobacterium tuberculosis RNA (SAT-RNA), real-time fluorescent thermostatic amplification detection of DNA (thermostatic amplification method) and traditional BACTEC MGIT 960 liquid culture (culture method) for special specimens of tuberculosis, in order to analyze its application value in clinical detection. Methods Using prospective research methods, a total of 170 special specimens (including 47 pleural and ascites effusion samples, and 34 24-hour urinary sediment specimens, 49 tissue specimens and 40 fester specimens) were collected i'an Chest Hospital from January to September 2021. GeneXpert Ultra, Xpert, FQ-PCR, SAT-RNA, isothermal amplification, and traditional culture were used for detection. Clinical diagnosis was used as the standard, and sensitivity, specificity, positive predictive value, negative predictive value, coincidence rate, and Kappa value were compared among the methods. Results The sensitivities of GeneXpert Ultra, Xpert, FQ-PCR, SAT-RNA, isothermal amplification, and traditional culture were 65.18% (73/112), 49.11% (55/112), 37.50% (42/112), 19.64% (22/112), 8.04% (9/112), and 22.32% (25/112), respectively. The sensitivity of GeneXpert Ultra was higher than that of the other five methods, and the differences were statistically significant (χ2=66.25, 42.10, 28.89, 13.09, 4.92, 15.18, all P<0.05). GeneXpert Ultra result analysis showed that: 5.48%(4/73) cases had trace, that is, trace Mycobacterium tuberculosis load, 79.45% (58/73) cases were extremely low, 10.96% (8/73) cases were low, 2.74% (2/73) were medium, , and 1.36% (1/73) were high load. In 4 trace samples, the Xpert detection was negative for all. Of the 73 GeneXpert Ultra positive reports, 63 were rifampicin-sensitive, 6 were rifampicin-resistant, and 4 were rifampicin-resistant but of unclear resistance. Of the 55 Xpert positive reports, 45 were rifampicin-sensitive, 2 were rifampicin-resistant, and 8 were rifampicinresistant but of unclear resistance.. Conclusions The new generation of GeneXpert MTB/RIF Ultra has high sensitivity, specificity and drug resistance detection rate, and its advantage is even more apparent in the pathogenic diagnosis of special specimens of tuberculosis. It can be used as one of the preferred methods in samples with low bacterial load.

Application of GeneXpert MTB/RIF technology in rifampicin resistance gene mutation of Mycobacterium tuberculosis / 中国热带医学

@#Abstract: Objective To analyze the accuracy and feasibility of GeneXpert MTB/RIF (GeneXpert) detection in the detection of Mycobacterium tuberculosis and the characteristics of rifampicin-resistant rpoB gene mutations. Methods A total of 4 234 sputum samples from suspected tuberculosis patients diagnosed in Sanya tuberculosis designated hospitals from 2015 to 2021 were selected and subjected to sputum smear, solid culture, drug sensitivity test by solid proportion method and GeneXpert detection. Results The positive detection rates of sputum smear, solid culture and GeneXpert of 4 234 sputum samples were 29.24% (1 238/4 234), 32.17% (1 362/4 234) and 35.40% (1 499/4 234), respectively. The positive detection rate of GeneXpert was higher than that of sputum smear, and the difference was statistically significant (χ2=36.775, P<0.01). It was slightly higher than solid culture, and the difference was not statistically significant (χ2=9.908, P=0.02). Taking solid culture results as the gold standard, the sensitivity and specificity of GeneXpert for detecting MTB were 91.04% (1 240/1 362) and 90.98% (2 613/2 872), respectively. According to the proportional drug susceptibility test results as the gold standard, the sensitivity and specificity of GeneXpert in detecting rifampicin resistance were 96.96% (96/99) and 98.86% (1 128/1 141), respectively, with the consensus rate of 98.71%. The accuracy of rifampicin resistance in GeneXpert group without probe mutation was significantly lower than that in group with probe mutation. There was a statistical difference in probe mutation frequency between newly treated and retreated cases. The analysis of rpoB gene mutation frequency characteristics showed: Probe E (50.00%) > Probe A (22.12%) > Probe D (14.42%) > Probe B (6.73%) > combined probe (5.77%) > Probe C (0.96%). Conclusions GeneXpert detection can quickly and effectively diagnose rifampicin-resistant tuberculosis, which is helpful for early clinical diagnosis and treatment. In this region, the rpoB gene mutation probes of rifampicin-resistant tuberculosis mainly occurr in Probe E and Probe A, with the least mutations in Probe C.

GeneXpert como método de diagnóstico de la tuberculosis en Santiago de Cuba / GeneXpert as diagnostic method of tuberculosis in Santiago de Cuba

Introducción: La tuberculosis es un problema de salud en el mundo, por lo que se necesitan métodos como el GeneXpert para realizar un diagnóstico rápido y seguro. Objetivo: Determinar la precisión del GeneXpert como método para el diagnóstico de la tuberculosis en Santiago de Cuba en relación con los estudios tradicionales. Métodos: Se efectuó un estudio descriptivo y transversal desde diciembre de 2018 hasta igual mes de 2019 de 31 pacientes a quienes se les realizaron los 3 métodos para el diagnóstico de la tuberculosis. Se utilizaron variables, tales como edad, sexo, muestras estudiadas, positividad de los métodos utilizados, así como concordancia entre el GeneXpert y el cultivo mediante el índice de Kappa. Resultados: En la serie predominaron los pacientes mayores de 50 años (48,4 %), el sexo masculino (66,7 %) y el esputo como muestra más representativa (80,6 %); asimismo, el cultivo resultó positivo en 32,3 % y el GeneXpert en 22,6 %. En tanto, se diagnosticó tuberculosis en 11 pacientes y el índice de Kappa fue de 0,58. Conclusiones: La determinación de GeneXpert en el diagnóstico de la tuberculosis es precisa, dada su sensibilidad y especificidad altas en relación con los estudios tradicionales de esputo y cultivo, lo cual se confirmó por la elevada concordancia del índice de Kappa.

Introduction: Tuberculosis is a health problem worldwide, reason why methods as the GeneXpert are needed to carry out a quick and safe diagnosis. Objective: To determine the accuracy of GeneXpert as a method for the diagnosis of tuberculosis in Santiago de Cuba in connection with the traditional studies. Methods: A descriptive and cross-sectional study was carried out from December, 2018 to the same month in 2019 of 31 patients to whom the 3 methods for the diagnosis of tuberculosis were carried out. Some variables were used, such as age, sex, studied samples, positivity of the used methods, as well as consistency between the GeneXpert and the culture by means of the Kappa index. Results: In the series there was a prevalence of the patients over 50 years (48.4 %), male sex (66.7 %) and sputum as more representative sample (80.6 %); also, the culture was positive in 32.3 % and GeneXpert in 22.6 %. As long as, tuberculosis was diagnosed in 11 patients and the Kappa index was 0.58. Conclusions: The determination of GeneXpert in the diagnosis of tuberculosis is necessary, given its high sensibility and specificity in connection with the traditional studies of sputum and culture, which was confirmed due to the high consistency of the Kappa index.

Novel biomarkers for Diagnosis of Pulmonary Tuberculosis and Tuberculous Pleural Effusion

Background: The present study aimed to evaluate the importance of serum, pleural adenosine deaminase (ADA), and Gene Xpert in Diagnosis of TB and TB Pleural Effusion (TB-PLE.).Material & Methods:The study was done with 75 TB cases, 50 cases of them were diagnosed as Pulmonary TB and 25 cases as TB pleural effusion, collecting also 50 non-TB pleural effusion, Malignant and acute bacterial infection comprise 21 and 29 cases respectively. Cases with transudative pleural effusion were excluded from the study. Finally, 75 were healthy control group.Results:There was a highly significant difference between the mean age of TB-PE Patients and Patients non-TB-PLE (P-value <0.001), while there was a non-significant difference with patients with P-TB (P-value >0.05). Mean of Serum ADA level were highest 53.16 U/L in TB-PE cases, shown to be statistically significant when compared to 43.2 U/L in P-TB and 25.4 U/L in non TBpleural effusion. With p-value of 0.02 and 0.001respectively.Conclusions:We concluded that GeneXpert can be a useful diagnostic method in patients with suspected pulmonary tuberculosis. Serum and pleural fluid ADA level is a very helpful test to rule out a TB and can help differentiate tubercular etiology from non-tubercular.

Clinical study of GeneXpert combined with T-SPOT and TB-Ab on bacterial-negative pulmonary tuberculosis / 中国热带医学

@#Abstract: Objective　To investigate the diagnostic efficacy of rifampin-resistant real-time fluorescent quantitative nucleic acid amplification detection technology (GeneXpert MTB/RIF) in bronchoalveolar lavage fluid (BALF) combined with peripheral blood tuberculosis infection T cell spot test (T-SPOT) and tuberculosis antibody (TB-Ab) in smear-negative pulmonary tuberculosis. Methods　The clinical data of 114 cases of clinically diagnosed smear-negative pulmonary tuberculosis, 80 cases of non-tuberculous pulmonary diseases and 22 cases of smear-positive pulmonary tuberculosis in our hospital from January 2019 to January 2021 were retrospectively analyzed. The detection results of peripheral blood T-SPOT, TB-Ab and BALF GeneXpert in the three groups were analyzed. The sensitivity, specificity, negative predictive value, positive predictive value, false negative rate, false positive rate and Youden index of the three detection methods were compared. The differences in the positive detection rate of smear-negative pulmonary tuberculosis between the separate detection and the combined detection of the three methods were compared. The receiver operating characteristic curve (ROC) was performed to calculate the area under the curve (AUC). Results　The sensitivity of BALF GeneXpert and peripheral blood T-SPOT and TB-Ab was 66.91%, 80.88% and 90.44%, respectively. The specificity was 98.75%, 73.75% and 41.25%, respectively; the diagnostic coincidence rates were 78.70%, 78.24% and 72.22%, respectively, which were higher than 70.00%. In the smear-negative pulmonary tuberculosis group, the positive detection rates of these three methods in the smear-negative pulmonary tuberculosis group were 63.15%, 79.82% and 90.35%, respectively, and the differences were statistically significant compared with those in the non-tuberculosis pulmonary disease group (all P<0.01). The positive detection rate of the three combined methods in the smear-negative pulmonary tuberculosis group was 96.49 %, which was significantly higher than that of TB-GeneXpert method and T-SPOT, and the differences were statistically significant (χ2=37.283, P<0.01; χ2=13.612, P<0.01); the Youden index of combined detection was significantly higher than that of single detection, and the AUC of combined detection was 0.977, which was significantly higher than that of single detection. Conclusion　BALF GeneXpert combined with peripheral blood T-SPOT and TB-Ab can significantly improve the diagnostic rate of bacterial-negative pulmonary tuberculosis, providing a strong basis for guiding clinical treatment.

O impacto do GeneXpert® MTB/Rif na detecção da tuberculose e seu padrão espacial em Ribeirão Preto-SP / The impact of GeneXpert® MTB/Rif in the detection of tuberculosis and its spatial pattern in Ribeirão Preto-SP

INTRODUÇÃO: Em 2010 a OMS autorizou o uso do sistema GeneXpert® MTB/RIF para a realização do Teste Rápido Molecular para TB (TRM-TB). Objetivou-se-se analisar o impacto do GeneXpert® MTB/RIF na detecção da TB e da TB multidroga-resistente e seu padrão de distribuição espacial em Ribeirão Preto-SP. MÉTODOS: Estudo ecológico realizado em Ribeirão Preto-SP. A população do estudo foi composta de casos de TB notificados no Sistema de Controle de Pacientes com Tuberculose (TBWeb) no período de 2006 a 2017. A análise descritiva dos casos foi realizada por meio de estatística descritiva dos parâmetros quantitativos através do software IBM SPS Statistics versão 25. Para classificar a tendência temporal e observar o impacto da implementação do TRM-TB, foram utilizadas as metodologias Prais-Winsten e Série Temporal Interrompida (STI) através do software StataSE versão 14 e também a modelagem ARIMA com a finalidade de obter uma previsão da taxa de TB para os próximos anos através do software RStudio. Para identificar os padrões espaciais da doença no município foram empregadas as técnicas de estimador de densidade de Kernel, G e G* e varredura (puramente espacial, variação nas tendências temporais e espaço-temporal). RESULTADOS: A tendência temporal da TB apresentou decréscimo de 18,1%/ano e de 6,9%/ano para em crianças. O Distrito Norte apresentou decréscimo de 6,67%/ano e o distrito Leste crescimento de 17,5%/ano na incidência de TB. A TB resistente, após a implementação do TRM-TB, apresentou aumento de 0,6% por ano. Na maioria dos anos analisados, a cultura é solicitada para menos da metade dos casos de TB. Foi identificado um aumento no número de solicitações de TMR e estacionariedade nas solicitações de baciloscopia. A maior parte dos casos foi diagnóstica por meio de demanda ambulatorial. Com as análises espaciais utilizadas foi observado que os casos e os aglomerados não se formam de maneira aleatória no espaço, verificando-se que a TB é distribuída desigualmente no município. CONCLUSÃO: Apesar da TB resistente não ser um problema no cenário, o estudo evidenciou um crescimento na sua incidência, o que o coloca em estado de alerta. O uso da análise espacial possibilitou a identificação das áreas prioritárias, colocando-as em evidência para ações de vigilância em saúde. Ressalta-se a importância do uso de ferramentas de análise espacial na identificação de áreas que devem ser priorizadas para o controle da TB, sendo necessária maior atenção aos indivíduos que se enquadram no perfil indicado como "de risco" para a doença

INTRODUCTION: In 2010, the WHO authorized the use of the GeneXpert® MTB/RIF system to perform the Molecular Rapid Test for TB (TRM-TB). The objective was to analyze the impact of GeneXpert® MTB/RIF in the detection of TB and multidrug-resistant TB and its spatial distribution pattern in Ribeirão Preto-SP. METHODS: Ecological study carried out in Ribeirão Preto-SP. The study population consisted of TB cases reported in the Tuberculosis Patient Control System (TBWeb) from 2006 to 2017. Descriptive analysis of cases was performed using descriptive statistics of quantitative parameters through the IBM SPS Statistics software version 25. To classify the temporal trend and observe the impact of the TRM-TB implementation, the Prais-Winsten and Interrupted Time Series (STI) methodologies were used through the StataSE software version 14 and also the ARIMA modeling in order to obtain a prediction of the TB rate for the coming years through RStudio software. To identify the spatial patterns of the disease in the city, the techniques of Kernel density estimator, G and G* and scanning (purely spatial, variation in temporal and spatio-temporal trends) were used. RESULTS: The temporal trend of TB showed a decrease of 18.1%/year and of 6.9%/year for children. The Northern District showed a decrease of 6.67%/year and the East District a growth of 17.5%/year in the incidence of TB. Resistant TB, after the implementation of the TRM-TB, increased by 0.6% per year. In most of the years analyzed, culture is requested for less than half of TB cases. An increase in the number of RMT requests and stationarity in smear microscopy requests was identified. Most cases were diagnosed through outpatient demand. With the spatial analysis used, it was observed that cases and clusters do not form randomly in space, verifying that TB is unevenly distributed in the municipality. CONCLUSION: Although resistant TB is not a problem in the scenario, the study showed an increase in its incidence, which puts it on alert. The use of spatial analysis made it possible to identify priority areas, putting them in evidence for health surveillance actions. We emphasize the importance of using spatial analysis tools to identify areas that should be prioritized for TB control, requiring greater attention to individuals who fit the profile indicated as "at risk" for the disease

Validation of the GeneXpert Xpress SARS-CoV-2 PCR assay using saliva as biological specimen

ABSTRACT In the pandemic, rapid and accurate detection of SARS-CoV-2 is crucial in controlling the outbreak. Recent studies have shown a high detection rate using saliva/oral fluids as specimens for laboratory detection of the virus. We intended to evaluate the test performance of the Xpert Xpress SARS-CoV-2 cartridge assay in comparison to a conventional qRT-PCR testing, using saliva as biological specimen. Forty saliva samples from symptomatic participants were collected. Conventional qRT-PCR was performed for amplification of E and RdRp genes and the Xpert Xpress SARS-CoV-2 assay amplified E and N2 genes. In the conventional assay, the median cycle threshold value of the E gene was 34.9, and of the RdRp gene was 38.3. In the Xpert Xpress assay, the median cycle threshold value of the E gene was 29.7, and of the N2 gene was 31.6. These results can allow a broaden use of molecular tests for management of COVID-19 pandemic, especially in resources-limited settings.

Accuracy of Nasopharyngeal Aspirate GeneXpert Compared to Gastric Aspirate TB Culture and GeneXpert in Diagnosing Pulmonary Tuberculosis in Pediatric Patients

Background@#Pulmonary TB in children remains to be a burden in the Philippines. Diagnosis remains to be a challenge for pediatricians due to its paucibacillary nature, difficulty in obtaining specimens, cost of test as well as the varied sensitivity of the different tests available. Gastric aspirate (GA), commonly used for bacteriological diagnosis of pulmonary tuberculosis (PTB) in children, involves an invasive procedure that may cause discomfort and sometimes require admission. Nasopharyngeal aspirate (NPA), on the other hand, can be easily and non-invasively obtained but is currently not a recommended specimen for testing for PTB. @*Objectives@#This study aims to determine the accuracy of NPA GeneXpert in diagnosing PTB among pediatric patients 0-18 years old with presumptive TB using GA GeneXpert as the initial screening test and GA TB culture as gold standard. @*Methodology@#This prospective, cross-sectional diagnostic study involved collection of single NPA and GA specimens for GeneXpert and TB culture in 100 patients with presumptive PTB seen at a tertiary government hospital in the Philippines. @*Results@#Of the one hundred pediatric patients (mean age 6 ± 5.63 years) enrolled, 50 were clinically diagnosed PTB, 16 bacteriologically-confirmed and 34 were not PTB disease. Sensitivity, specificity and predictive values with 95% confidence intervals of the NPA GeneXpert were determined compared to GA GeneXpert and GA culture. Sensitivity, specificity, positive and negative predictive values of the NPA GeneXpert compared to GA GeneXpert were 70%, 96.67%, 70% and 96.67%, respectively. While NPA GeneXpert compared to GA TB culture were 40%,91.58%, 20% and 96.67%, respectively. @*Conclusion@#GeneXpert testing on a single NPA specimen is a highly specific and rapid test that can be used to diagnose PTB in pediatric patients, particularly where gastric aspiration or mycobacterial culture is not feasible.

Serious discordance between MTBC trace positivity by Xpert MTB/RIF ultra and follow up culture

Authors wish to report a major discordance between Xpert MTB/RIF Ultra Trace positivity (GeneXpert, Cepheid) and follow up by liquid culture.

A study to compare the diagnostic accuracy of GeneXpert MTB/RIF/assay and its comparison with liquid culture in clinically suspected cases of genital tuberculosis attending outpatient department of tertiary center

Background: Tuberculosis is a major health issue globally despite a declining trend in mortality with effective diagnosis and treatment, an estimated 10.4 million persons developing active TB each year with 1.33 million deaths. Objective of this study was to evaluate role of GeneXpert MTB/RIF/assay in diagnosis of female genital tuberculosis in suspected cases of tuberculosis.Methods: It was a cross sectional study done in department of obstetrics and gynecology in S. N. Medical college Agra for a period of 2 year (July 2017 to October 2019). 70 cases were selected from OPD of department of obstetrics and gynecology, S. N. Medical College Agra who met the inclusion and exclusion criteria after taking proper consent. In all selected cases endometrial biopsy sample was taken using endometrial biopsy curette in premenstrual period. All samples of endometrial biopsy were taken under all aseptic precaution from both corneal ends, anterior and posterior wall and lower part of uterus using endometrial biopsy curette and sample was collected in two separate sterile vials having normal saline and was sent for GeneXpert MTB/RIF/assay and liquid culture simultaneously.Results: Out of total 70 clinically suspected cases of female genital tuberculosis in between 20-45 years of age cough with expectoration 94% was the most common respiratory symptom followed by fever 81%, weight loss 56% and anorexia 54%. Prevalence of genital tuberculosis in active pulmonary tuberculosis patients was 30%. Irregular menstruation, vaginal discharge and pelvic pain were present in 69%, 60% and 52% patients respectively.Conclusions: The overall sensitivity of CBNAAT was 22% and specificity was 77%. The overall sensitivity of liquid culture was 28% and specificity was 71%.

Comparison of diagnostic accuracy of bactec culture, gene-xpert and histopathology in the diagnosis of genital tuberculosis in women with infertility

Background: Female genital tuberculosis (FGTB) is often a silent disease sparing no age group but majority of patients are in the reproductive age. In infertility patient’s incidence of FGTB varies from 3-16% in India but the actual incidence of genital tuberculosis may be under reported due to asymptomatic presentation and paucity of investigations.Methods: Prospective case control study was conducted from June 2018 to May 2019 in LLRM Medical College Meerut. A total 100 Endometrial samples were collected during diagnostic laparoscopy from all suspected case of genital TB, presented with either primary or secondary infertility and samples sent for histopathology, Gene-xpert and Bactec culture.Results: Out of 100 samples Bactec culture was positive in 2 samples, Gene-xpert positive in 3 samples. On histopathology out of 100 cases, non-specific endometritis was found in 1 case, tubercular-endometritis in 1 case, proliferative enometrium (anovulatory) in 40 cases and secretory endometrium found in 58 cases.Conclusions: Female genital TB poses a diagnostic dilemma because of its varied presentation and lack of sensitive and specific method of diagnosis. Culture though remains the gold standard of diagnosis of female genital TB, gene-xpert, histopathology, Bactec culture or laparoscopy can be used for starting treatment. Endometrial biopsy on histopathology shows not only Tubercular endometritis but also gives hormone response on endometrium, local factors of endometrium concerning non-specific and specific infections and anovulatory cycles.

GeneXpert MTB/RIF evaluated in diagnosis of pulmonary tuberculosis / 上海预防医学

Objective To evaluate GeneXpert MTB/RIF in diagnosis of pulmonary tuberculosis by comparing the lab results of diagnosed patients. Methods A total of 97 diagnosed pulmonary tuberculosis patients were enrolled from July 2017 to June 2018.Sputum smear microscopy (Ziehl-Neelsen stain), sputum culture (MGIT liquid culture) and Xpert MTB/RIF were conducted in all patients.Drug susceptibility test and strain identification by PNB were done for culture positive sputum samples.Consistency rate was calculated. Results In terms of M.tuberculosis detection, sensitivity and specificity of GeneXpert were 93.44% and 55.55%, respectively, compared with bacteriological examination (consistency rate 79.38%).Consistency rate of GeneXpert and PNB is 94.55%.In terms of RIF resistance test, sensitivity and specificity of GeneXpert were 66.67% and 98.08%, respectively, compared with phenotypic drug-susceptibility testing (consistency rate 96.36%). Conclusion GeneXpert MTB/RIF can be utilized in combination with smear microscopy and liquid culture to diagnose more etiologically positive patients, and can spot RIF resistance patients early.But strain identification and drug susceptibility test are still needed for individualized therapy and optimal treatment outcome.

GeneXpert MTB/RIF evaluated in diagnosis of pulmonary tuberculosis / 上海预防医学

Objective To evaluate GeneXpert MTB/RIF in diagnosis of pulmonary tuberculosis by comparing the lab results of diagnosed patients. Methods A total of 97 diagnosed pulmonary tuberculosis patients were enrolled from July 2017 to June 2018.Sputum smear microscopy (Ziehl-Neelsen stain), sputum culture (MGIT liquid culture) and Xpert MTB/RIF were conducted in all patients.Drug susceptibility test and strain identification by PNB were done for culture positive sputum samples.Consistency rate was calculated. Results In terms of M.tuberculosis detection, sensitivity and specificity of GeneXpert were 93.44% and 55.55%, respectively, compared with bacteriological examination (consistency rate 79.38%).Consistency rate of GeneXpert and PNB is 94.55%.In terms of RIF resistance test, sensitivity and specificity of GeneXpert were 66.67% and 98.08%, respectively, compared with phenotypic drug-susceptibility testing (consistency rate 96.36%). Conclusion GeneXpert MTB/RIF can be utilized in combination with smear microscopy and liquid culture to diagnose more etiologically positive patients, and can spot RIF resistance patients early.But strain identification and drug susceptibility test are still needed for individualized therapy and optimal treatment outcome.

Socio-demographic Factors Associated with Treatment Initiation Delays among Tuberculosis Patients in Namibia

Background: Delayed tuberculosis (TB) treatment increases the rate of spread of the bacilli in the community and mortality rates. Rapid diagnosis and early TB treatment initiation are crucial to successful outcomes and delays affect TB control programs. In Namibia, there is a paucity of data on the demographic factors affecting TB treatment initiation since GeneXpert MTB/RIF (Xpert) assay was introduced in 2017. Methods:This was a descriptive cross-sectional retrospective study conducted at Katutura Hospital TB clinic from 1stJuly 2018 to 31stMarch 2019. A total of seventy-two (72) participants comprising twenty-five (25) rifampicin resistant-TB (RR-TB) and forty-seven(47) non-RR-TB adult patients were enrolled using consecutive sampling. Patients’ medical records, Xpert results and a questionnaire were used to collect data. The data were analyzed using Stata statistical software version 12. Association between socio-demographic factors and treatment initiation delays were established using logistic regression analysis.Results:Staying with a TB patient (AOR=17.22, 95% CI: 2.29-129.773), employment status (AOR=1.23, 95% CI, 002-129), previous TB treatment (AOR=2.19, 95% CI: 0.076-0.86) and being HIV positive (AOR= 1.23, 95% CI: 0.0034-057) were thesocio-demographic factorsthat weresignificantly associated with treatment initiation delays.Treatment initiation delay median time at Katutura Intermediate Hospital TB Clinic was 10 days (IQR: 1-32) and 3 days (IQR: 0-12) for RR-TB and non-RR-TB respectively.Conclusion: The prolonged treatment initiation delays among HIV positive RR-TB patients might be due to low adherence to HIV care interventions. Staying with a household TB patient and those who were previously treated for TB were also associated with treatment initiation delays. Poor health systems infrastructure and stigma could be the determinants of this delay in these groups. An integrated family-based approach to TB and HIV care involving health care workers can mitigate TB treatment delays post-diagnosis. Further studies should explore the factors associated with late initiation to second-line treatment from a community perspective. Lastly, there is a need to assess the cost-utility of bedaquiline and delamanid drugs roll-out in Namibian health care in comparisonwith the standard treatment.

Comparative Evaluation of GENE-XPERT MTB/RIF with AFB Smear Microscopy Methods for the Diagnosis of Tuberculosis in Sputum Specimens of Suspected Pulmonary Tuberculosis Patients

Tuberculosis is a major public health problem worldwide and remains one of the most significant causes of death from an infectious agent. India contributes to 25.5% of the global new TB case detection. In recent times, emphasis has shifted from older phenotypically and biochemical methods of diagnosis to molecular methods such as GeneXpert MTB/RIF, a real time PCR that can detect MTB and rifampicin resistence simultaneously. Methods: This study aims at assessing the performance of acid fast bacilli (AFB) smear microscopy in comparison with GeneXpert MTB RIF, in the diagnosis of pulmonary tuberculosis. Study was a cross-sectional study carried out at the Department of Pulmonary Medicine, Muzaffarnagar Medical College, from January 2018 to April 2019. Result: The detection of MTB and rifampicin resistance using the Xpert MTB/RIF assay was assessed in 67 specimens from patients suspected of having pulmonary tuberculosis and compared with conventional smear microscopy. Out of these 67 sputum specimens, 38 samples were MTB positive by smear microscopy while 56 samples were MTB detected by Gene Xpert assay. Gene Xpert detected 18 additional tubercular cases and identify two cases of Rifampicin resistant MTB. Conclusion: Study show that there was no statistically significance in diagnostic value between GeneXpert and AFB smear microscopy in sputum samples however Gene Xpert MTB/RIF is useful method for rapid detection of MTB and Rifampicin resistance simultaneously.

Efficacy of gene xpert over other diagnostic modalities of tuberculosis among children

Background: Diagnosis of tuberculosis is a challenge especially among children. GeneXpert has been recommended as a diagnostic test in children. Objectives of this study was to efficacy of GeneXpert over other diagnostic modalities of Tuberculosis like Sputum smear microscopy, Mantoux testing, X-ray chest among children.Methods: A cross sectional hospital-based study was conducted over a period of 24 months among 150 children. All the patients who were having suspicion of Tuberculosis on the basis of History & Examination (fulfilling inclusion criteria) had been enrolled in the study. After doing all preliminary investigations clinical diagnosis has been made and Gene X'pert was carried out for all the samples collected. Pearson chi square test and Fishers exact test was applied wherever appropriate.Results: There was statistically no significant (p >0.05) difference of GeneXpert positivity within different age groups of Suspected TB patients. GeneXpert was positive in 80% with symptom of Cough lasting more than 2 weeks, in 78.8% with fever more than 2 weeks, in 88.9% with FTT, in 76.5% with H/O Koch's contact, in 77.8% with H/O convulsion, in 69% with significant lymphadenopathy. GeneXpert was positive in all suspected TB patients having ZN staining positive for AFB. In clinically TB diagnosed patients, 86.5% were positive for GeneXpert.Conclusions: GeneXpert is a novel diagnostic modality of choice in all suspected Pulmonary & Extra-pulmonary TB cases among children. It can be used as a primary tool in Pulmonary TB with smear negative samples in pediatric age group.

Prevalence of Genital Tuberculosis in Infertile Women; a Study from a Tertiary Care Center in North India

Introduction: Female genitourinary tuberculosis (FGTB) is an important cause of infertility in women of reproductive age group. The disease remains undetected due to its asymptomatic nature and lack of sensitive tests. This study was conducted with the aim of detecting the prevalence of genital tuberculosis in infertile women. Material and methods: Endometrial curetting of 193 infertile women suspected of genital tuberculosis were taken laparoscopically and sent for histopathological examination, ZN staining, culture on LJ media and GeneXpert testing. Results: Out of 193 women, 13 were positive for Mycobacterium tuberculosis making the overall prevalence of FGTB in infertile women to the extent of 6.73%. Of these 11 presented with primary infertility while 2 patients presented with secondary infertility. The histopathological examination of all the samples was non-specific. No case of positive acid fast bacilli on ZN staining was observed. Comparison of culture and GeneXpert revealed that Xpert assay was more sensitive in detecting the positive cases. Conclusion: Our study concluded that FGTB is common in our population and women presenting with infertility should be evaluated for genital tuberculosis. A high degree of suspicion and combination of histopathological and microbiological tests are important methods for the detection of genital tuberculosis

A Retrospective Review of Rifampicin-Resistant Mycobacterium tuberculosis between 2015 and 2017 in Port Harcourt, Nigeria

Background:The diagnosis and treatment of drug resistant tuberculosis (TB) is a significant challenge for the control of TB in Nigeria. Aim: The study was carried out to assess the prevalence of rifampicin-resistant TB at the point of initial diagnosis among subjects suspected of TB.Methods: A retrospective review of Mycobacterium tuberculosis (MTB)and rifampicin resistance detected by GeneXpert™ analysis between 2015 and 2017 in Braithwaite Memorial Specialist Hospital was carried out. Results: A total of 6733 samples were received and analyzed in the period under review, 1252 (19%) were positive for Mycobacterium tuberculosisand 5841 (81%) were negative. The Original ResearchArticle prevalence of Mycobacterium tuberculosis was 24.56%, 20.11% and 16.86% from 2015 to 2017 respectively. There was a significant decline in the prevalence of MTB from 2015 to 2017 (2= 33.59, p = 0.0001). Rifampicin (RIF) resistance was 5.42%, 5.86% and 6.22% respectively from 2015 to 2017;but the trend was not statistically significant (2 = 0.21; p = 0.6418). Conclusion: The study showed that despite a decrease in the prevalence of tuberculosis infection there was an increase in rifampicin resistance from 5.42% to 6.22% between 2015 and 2017. There is an urgent need to improve the management of TB in the Port Harcourt metropolis to improve treatment outcomes and to prevent the proliferation of drug resistant strains

EPTB diagnosis by GeneXpert MTB/RIF test and its Clinical-epidemiological profile

GeneXpert is a novel, automated diagnostic test that can identify Mycobacterium tuberculosis (MTB) DNA and resistance to rifampicin (RIF) rapidly for Extrapulmonary tuberculosis (EPTB). Incidence of EPTB is increasing in low burden settings in comparison to pulmonary tuberculosis (PTB) & EPTB is relatively neglected. Aim: This study is aimed at knowing the incidence of EPTB and rifampicin sensitivity using an automated rapid detection method, GeneXpert. Methods: 271 EPTB positive patients were included in this retrospective study during a period from January to July 2018. Details regarding TB diagnosis, rifampicin sensitivity, nature of the sample and patient details including age, sex, occupation, address, habits, past history of TB, HIV status and other clinically relevant information was obtained from hospital and laboratory registers. Results: Out of 1290 tuberculosis positive patients, 1019 were of pulmonary tuberculosis (PTB) i.e., 78.9% and remaining 271 were of extrapulmonary tuberculosis (EPTB) i.e., 21.1%. 42.4% (115 out of 271) patients were in the age group of 31-40 years. Female predominance was observed in EPTB patients. Among 271 EPTB patients, 122 (45%) were diagnosed as pleural TB, 95 (35%) patients affected by tuberculosis at lymphnodes, 3(1.1%) had meningeal TB, 9(3.3%) EPTB cases were diagnosed from pus samples of various clinical conditions and remaining 42(15.4%) EPTB cases identified from various samples including tissues, genitourinary, synovial fluid, bones & joints. 247 (91.1%) out of 271 EPTB patients clinical samples showed rifampicin sensitive. 12 (9.8%) out of 122 pleural tuberculosis cases and 5 (5.2%) out of 95 TB lymphadenitis cases showed resistant rifampicin. Conclusion: TB can be diagnosed by various methods, among which GeneXpert is a rapid, reliable, easy to operate, automated system. GeneXpert helps physicians by providing rapid diagnosis within 90 minutes, in turn aid to initiate prompt treatment at the earliest.

Evaluation of genital tuberculosis as a cause of female infertility in a tertiary care hospital in North India

Background: Female genital tuberculosis (FGTB) poses a great diagnostic challenge in women of reproductive age. It causes significant morbidity or short and long term sequelae, especially infertility. The disease often remains silent or may present with non-specific symptomatology. As a result, the prevalence of genital tuberculosis is largely underestimated. A high degree of suspicion aided by intensive investigations is important in the diagnosis of the disease, especially in its early stage, so that treatment may improve the prospects of cure before the tubes are damaged beyond recovery. Objectives were to find out the prevalence of genital tuberculosis in females presenting with infertility in a tertiary care hospital over a given period of time, and diagnostic comparison of endometrial tuberculosis by histopathological examination (HPE) and GeneXpert.Methods: The prospective observational study was conducted over one year duration. A total of 96 endometrial samples were collected from the women, satisfying the inclusion and exclusion criteria.Results: On HPE, out of 96 patients, proliferative endometrium (anovulatory) was found in 38 cases (39.6%), non-specific endometritis in 2 cases (2.08%) and 2 cases (2.08%) were found positive for tubercular endometritis. GeneXpert scored negative in our study.Conclusions: Endometrial biopsy shows not only the tuberculous endometritis, but also gives additional information about local factors of endometrium concerning non-specific and specific infections and anovulatory cycles. GeneXpert if positive on endometrial biopsy is a reliable test for FGTB and treatment can be started on its basis