scholarly journals Use of GeneXpert and the Role of an Expert Panel in Improving Clinical Diagnosis of Smear-Negative Tuberculosis Cases

Author(s):  
Jovilia Abong ◽  
Victoria Dalay ◽  
Ivor Langley ◽  
Ewan Tomeny ◽  
Danaida Marcelo ◽  
...  

Setting A high proportion of notified tuberculosis cases in the Philippines are clinically diagnosed (63%) as opposed to bacteriologically confirmed. Better understanding of this phenomenon is required to improve tuberculosis control. Objectives To determine the percentage of Smear Negative Presumptive Tuberculosis patients that would be diagnosed by GeneXpert; compare clinical characteristics of patients diagnosed as tuberculosis cases; and review the impact that the current single government physician and a reconstituted Tuberculosis Diagnostic committee (Expert Panel) may have on tuberculosis over-diagnosis. Design This is a cross-sectional study of 152 patients 15-85 years old with two negative Direct Sputum Smear Microscopy results, with abnormal chest X-ray who underwent GeneXpert testing and review by an Expert Panel. Results 31% (48/152) of the sample were Xpert positive. 93% (97/104) of GeneXpert negatives were clinically diagnosed by a Single Physician. Typical symptoms and X-ray findings were higher in bacteriologically confirmed tuberculosis. When compared to GeneXpert results, the Expert panel’s sensitivity for active tuberculosis was high (97.5%, 39/40) but specificity was low (40.2%, 35/87). Conclusion Using the GeneXpert would increase the level of bacteriologically confirmed tuberculosis substantially among presumptive Tuberculosis. An Expert panel will greatly reduce over-diagnosis usually seen when a decision is made by a Single Physician.

Author(s):  
Tade Bagbi ◽  
Ningthoukhongjam Reema ◽  
S. Bhagyabati Devi ◽  
Thangjam Gautam Singh ◽  
Mohammad Jaleel ◽  
...  

Abstract Introduction Tuberculosis (TB) in people living with human immunodeficiency virus (PLHIV) is difficult to diagnose due to fewer organisms in sputum and extrapulmonary samples. Sputum culture takes 4 to 8 weeks for growth of the mycobacteria. Delayed treatment for TB in PLHIV leads to increased mortality. This study evaluated cartridge-based nucleic acid amplification test (CBNAAT) as a diagnostic tool for diagnosis of pulmonary TB (PTB) and extrapulmonary TB (EPTB) in PLHIV in the second most HIV prevalent state in India and for comparing its efficacy between Ziehl–Neelsen (ZN) staining sputum smear–positive and sputum smear–negative TB. Methods This cross-sectional study was conducted in RIMS, Imphal, with 167 PLHIV patients, age 15 years or older, having signs and symptoms of TB. Appropriate samples for sputum microscopy and CBNAAT were sent. Conclusion The overall sensitivity of sputum smear for acid-fast bacillus (AFB) was found to be 30.71% and that of CBNAAT was 38.57%. Sensitivity of CBNAAT for sputum smear–positive and sputum smear–negative TB was 100 and 11.3%, respectively. Sensitivity of ZN smear for AFB of EPTB sample was 48.1% and that of CBNAAT was 59.25%. In both PTB and EPTB, CBNAAT showed an increase in diagnosis of microbiologically confirmed PTB cases by 7.8 and 11.1%, respectively, over and above the cases diagnosed by ZN smear microscopy. Rifampicin resistance was detected in five patients. We conclude that CBNAAT is a rapid test with better sensitivity in diagnosis of PTB and EPTB in PLHIV, compared with ZN smear microscopy. It detects rifampicin resistance for multidrug-resistant TB and helps in early treatment intervention.


2019 ◽  
Vol 2 (1) ◽  
pp. 1-7
Author(s):  
Bibek Rajbhandari ◽  
Navin Kumar Chaudhary

Introduction: Tuberculosis remains of public health concern, particularly in highly endemic regions.1 It accounts globally for 3 million deaths annually. Pulmonary tuberculosis is primarily diagnosed by identification of Mycobacterium tuberculosis using sputum smear microscopy.2 Clinicians often depend on alternative diagnostic algorithms based on patient symptoms and chest X-ray findings, which have low sensitivity which may lead to either over or under diagnosis of pulmonary tuberculosis. The GeneXpert assay has been shown to have an accuracy comparable to that of culture.3 The sensitivity of a single GeneXpert result in smear-negative, culture-positive cases is 72.5%; the sensitivity increases with repeated testing.4 Xpert has been found to be a cost-effective method for smear-negative TB diagnosis in comparison to traditional methods in resource-limited settings. The aim of the study was to find the prevalence of Genexpert Positive in Sputum negative cases. Methods: This descriptive cross sectional study was done in Bir Hospital, Mahabouddha, Kathmandu for 1 year after taking ethical clearance. Data was collected and entry was done with point estimate at 95%. Sample size was calculated using the standard formula. Convenience Sampling technique was used, data analysis was done with SPSS Microsoft Excel Sheet. Results: Prevalence of Genexpert Positive in Sputum negative cases was part to be 27.27%. Conclusions: Present study showed GeneXpert could be used as a diagnostic tool for the diagnosis of tuberculosis by correlating the clinicoradiological features to this infectious disease. With judicious case detection and implementing appropriate measures, TB incidence, prevalence and morbidity can be minimized to a greater extent. Keywords: acid fast bacilli; tuberculosis; X-ray.


Author(s):  
R. Behzadmehr ◽  
E. Nejadkehkha

Despite many advances in the diagnosis, screening, and rapid treatment of tuberculosis, it is still a public health concern in the world. Due to the importance of this issue in diagnosis and reduction of transmission of infection and treatment of the disease especially where this study is conducted due to the high prevalence of tuberculosis, this study was done to determine The relationship between sputum smear positivity grade and chest X-ray findings in pulmonary tuberculosis patients in a hospital in southeast of Iran. This cross-sectional study was performed on all patients with pulmonary TB referencing the health centers in Zabol city, southeast of Iran from 1 January 2015 to 30 December 2020. Sputum smear and radiographic findings of the chest X-ray were evaluated. Data was collected using a form of information and finally analyzed by SPSS 22. Out of 101 patients examined in the present study, 71 were women and 30 were men. The mean age of the patients was 62.68 ± 13.61 years. The frequency of opacity in patients with grades 1, 2, and 3 was 71.4, 78.5, and 76.5%, respectively. Frequency of cavitation in patients with Grade 1, 2 and 3 was 11.5%, 28.5% and 52.9% respectively (P value 0.001). The frequency of reticulonodular presentations in patients with grade 1, 2, and 3 was 24.2, 7.1, and 0%, respectively.  In general, the results of this study showed that, with increasing grading of smears (1+, 2+, and 3+), the frequency of cavitation presentation increased significantly and the frequency of reticulonodular presentations decreased significantly. In general, the results of this study showed that, with increasing grading of smears (, the frequency of Cavitation presentation increased significantly and the frequency of reticulonodular presentations decreased significantly. The findings of the present study can help physicians better diagnose TB.


2020 ◽  
Author(s):  
Letebrhan Weldemhret

Abstract Background: Sputum smear microscopy remains the most cost-effective tool for tuberculosis diagnosis and treatment monitoring in resource constrained settings. Random blinded rechecking is a reliable tool to measure and improve smear microscopy. So, this study was intended to assess random blinded rechecking of AFB smear microscopy performance in selected private health facilities in Tigray region, Northern Ethiopia.Methods: A cross sectional study was conducted from April 1st 2017 to May 30, 2017. The data was collected using standard data collection form. Statistical analysis was done using SPSS version 25 and the reading agreement was done using kappa statistics.Results: Of the total 269 blinded rechecked smears, 4.8% was found discrepant findings. The major and minor errors were reported by 2.6% (7/269) and 2.2% (6/269) respectively. Likewise, the major error was reported by 50% (5/10) of health facilities with microscopic center. Overall, the sensitivity, specificity, positive predictive value, and negative predictive value of the blinded rechecking smears were 87.5%, 98%, 89.7% and 97.8%, respectively with substantial reading agreement, kappa value= 0.80.Conclusions: The overall performance of blinded rechecking was satisfactory with good smear reading agreement. But, the major error reported indicated unacceptable performance. To minimize the discrepancy, private health facilities with tuberculosis smear microscopic center should adhere to national tuberculosis guidelines.


2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Priyatam Khadka ◽  
Januka Thapaliya ◽  
Ramesh Bahadur Basnet ◽  
Gokarna Raj Ghimire ◽  
Jyoti Amatya ◽  
...  

Abstract Background In most developing countries, smear-negative pulmonary TB (SNPT) often gets missed from the diagnosis of consideration, though it accounts 30–65% of total PTB cases, due to deficient or inaccessible molecular diagnostic modalities. Methods The cross-sectional study enrolled 360 patients with clinical-radiological suspicion of SNPT in Tribhuvan University Teaching Hospital (TUTH). The patient selection was done as per the algorithm of Nepal’s National Tuberculosis Program (NTP) for Xpert MTB/RIF testing. Participants’ demographic and clinical information were collected using a pre-tested questionnaire. The specimens were collected, processed directly for Xpert MTB/RIF test according to the manufacturer’s protocol. The same samples were stained using the Ziehl-Neelsen technique then observed microscopically. Both findings were interpreted; rifampicin-resistant, if obtained, on Xpert testing was confirmed with a Line Probe Assay. Result Of 360 smear-negative sputum samples analyzed, 85(23.61%) found positive while 3(0.8%) of them were rifampicin resistance. The infection was higher in males, i.e. 60(25.3%) compared to female 25(20.3%). The age group, > 45(nearly 33%) with median age 42 ± 21.5, were prone to the infection. During the study period, 4.6% (515/11048) sputum samples were reported as smear-positive in TUTH. Consequently, with Xpert MTB/RIF assay, the additional case 16.5% (n = 85/515) from smear-negative presumptive TB cases were detected. Among the most occurring clinical presentations, cough and chest pain were positively associated with SNPT. While upper lobe infiltrates (36.4%) and pleural effusion (40.4%) were the most peculiar radiological impression noted in PTB patient. 94 multi-drug resistant(MDR) suspected cases were enrolled; of total suspects, 29(30.8%) samples were rifampicin sensitive, 1(1.06%) indeterminate, 3(3.19%) rifampicin-resistant while remaining of them were negative. 2(2.2%) MDR cases were recovered from the patient with a previous history of ATT, of total 89 previously treated cases enrolled However, a single rifampicin-resistant from the new suspects. Conclusion With an application of the assay, the additional cases, missed with smear microscopy, could be sought and exact incidence of the diseases could be revealed.


Author(s):  
Oladoyinbo O. Samuel ◽  
Pierre J.T. De Villiers

Background: In 2009 Lesotho had an estimated TB prevalence of 696 cases/100 000 population − the 4th highest in the world. This epidemic was characterised by high rates of death, treatment failure and unknown treatment outcomes. These adverse outcomes were attributable to a high rate of TB and/or HIV co-infection and weaknesses in the implementation of Lesotho’s National Tuberculosis Programme (NTP). This study was conducted in St Joseph’s Hospital, Roma (SJHR) to assess the implementation of the NTP.Method: Records of 993 patients entered into the SJHR TB register between 2007 and 2008 were reviewed. Patients’ treatment details were extracted from the register, validated and analysed by STATA 10.0.Results: Of 993 patients registered: 88% were new patients, 37% were diagnosed on sputum smear microscopy alone, 35% were diagnosed on sputum smear microscopy with chest X-ray, whilst 25% were diagnosed on chest X-ray alone. In addition: 33% were sputum smear positive, 45% were sputum smear negative, and 22% had extra-pulmonary TB. As to treatment outcome: 26% were cured, 51% completed treatment, and 51% converted from sputum smear positive to sputum smear negative over six months, whilst 16% died. Regarding HIV, 77% of patients were tested for HIV and 59% had TB and/or HIV co-infection. Of ten NTP targets only the defaulter and treatment failure rate targets were met.Conclusion: Whilst only two out of ten NTP targets were met at SJHR in 2007–2008, improvements in TB case management were noted in 2008 which were probably due to the positive effects of audit on staff performance.


2020 ◽  
Author(s):  
Yared Merid ◽  
Elena Hailu ◽  
Getnet Habtamu ◽  
Melaku Tilahun ◽  
Markos Abebe ◽  
...  

Abstract Background Understanding the epidemiology of tuberculosis (TB) is limited by lack of genotyping data. We sought to characterize the drug susceptibility testing (DST) patterns and genetic diversity of M. tuberculosis (Mtb) isolates in Southern Ethiopia. Methodology A cross-sectional study was conducted among newly diagnosed sputum smear positive patients with TB visiting nine health facilities in southern Ethiopia from June 2015 to May 2016. Three consecutive sputum samples (spot-morning-spot) per patient were examined using acid-fast bacilli (AFB) smear microscopy with all smear positive specimens having AFB cultures performed. Mtb isolates had DST performed using indirect proportion method and were genotyped with RD9 deletion typing and spoligotyping. Spoligotyping International Types (SIT) and sub-lineages (clades) were assigned according to the SITVITWEB data base. Results Among 250 newly diagnosed patients with TB, 154 (52%) were male and 143 (57%) from rural areas. The prevalence of HIV co-infection was 4%. Of the 250 AFB positive sputum samples, 230 (92%) were culture positive. All 230 isolates were M. tuberculosis strains belonging to three lineages: Euro-American, 187 (81%); East-African-Indian, 31 (14%); and Lineage 7 (Ethiopian lineage), 8 (4%). The 230 isolates could be categorized into 65 different spoligotype patterns, of which 84% fell into 29 clusters. The dominant spoligotypes were SIT149 (21%), SIT53 (19%) and new strains (16%). Mtb strains were clustered by districts. DST revealed that 14% of Mtb isolates were resistant to > 1 first line anti-TB drugs including 11% to isoniazid. SIT 149 was the most prevalent genotype among drug resistant isolates (20%). Conclusion The study revealed several clusters including lineage 7 strains circulating in southern Ethiopia. SIT 149 (T3-ETH) was the most dominant circulating strain in the study area including among drug-resistant cases.


PLoS ONE ◽  
2020 ◽  
Vol 15 (10) ◽  
pp. e0239342
Author(s):  
Letebrhan Weldemhret ◽  
Ataklti Hailu ◽  
Goyitom Gebremedhn ◽  
Hadish Bekuretsion ◽  
Gebreselassie Alemseged ◽  
...  

2005 ◽  
Vol 35 (4) ◽  
pp. 215-217 ◽  
Author(s):  
Andargachew Mulu ◽  
Afework Kassu

A cross-sectional study was conducted in Northwestern Ethiopia involving 18 health-care institutes in August 2003 to assess the physical conditions and current laboratory practice, pertaining to handling sputum specimens in the health-care laboratories carrying out sputum smear microscopy. A structured and pre-tested questionnaire was used to collect information. The laboratories had an area of less than 25 m2. None of them had separate rooms or safety cabinets for sputum smear preparation. Only three laboratories used facemasks. QJ;Decontamination of sputum specimens prior to disposal was reported in only two. Incineration as a means of sputum specimen disposal was used in only six laboratories. The physical conditions of the laboratories were found below the standard set by the International Union Against Tuberculoses and Lung Diseases. A large number of sputum specimens continue to be handled, despite the poor conditions and procedures in all the healthcare laboratories. Laboratory safety standards need to be improved, to minimize the risk of infection. In addition, there is an urgent need for education, training and supervision of the staff involved in sputum microscopy.


2020 ◽  
Vol 8 (1) ◽  
pp. 19-22
Author(s):  
Subodh Sagar Dhakal ◽  
Ashmita Neupane ◽  
Shatdal Chaudhary ◽  
Navin Mishra ◽  
Damber Bdr Karki

INTRODUCTION: Sputum smear examination for acid fast bacilli (AFB) by Ziehl-Neelsen stain (ZN stain) is the initial approach to the diagnosis of pulmonary tuberculosis (PTB). But 50% of the cases are reported to be sputum smear negative. This study was aimed to investigate the diagnostic yield of fibreoptic bronchoscopy (FOB) guided bronchoalveolar lavage (BAL) in patients suspected to have tuberculosis. The sample was tested for Mycobacterium tuberculosis using the XpertMTB/RIF assay, which is a new test that detects Mycobacterium tuberculosis complex and resistance to rifampin in less than two hours. MATERIAL AND METHODS: This is a prospective cross sectional study carried out on 58 sputum smear negative patients who were clinically suspected to have pulmonary tuberculosis from April 2017 to January 2019. All patients are subjected to FOB, BAL and BAL specimens were stained for AFB and also sent for Xpert (MTB)/RIF. RESULTS: Among 58 patients enrolled for the study 26 patients were positive for acid fast bacilli (AFB) through BAL stain and Xpert (MTB)/RIF combined. CONCLUSION: FOB guided BAL is a reliable, alternative and rapid method for diagnosing smear negative pulmonary tuberculosis with minimal complications.


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