scholarly journals DIAGNOSTIC ACCURACY OF XPERTMTB/RIF ASSAY IN DETECTION OF PULMONARY TUBERCULOSIS AND RIFAMPICIN RESISTANCE IN COMPARISON WITH CONVENTIONAL METHODS.

2019 ◽  
pp. 1-3
Author(s):  
B.V. Ramana* ◽  
A. Srikar ◽  
P. Prakash ◽  
Abhijit Chaudhury

Introduction: Tuberculosis is one of the oldest diseases with high morbidity and mortality. India accounts for one- fourth of the global TB burden (2.7million cases). Material and methods: A total 1056 patients were included in this study. All patients were requested to give two sputum samples, spot sputum sample (at the time of visit) and early morning sputum for mycobacterial testing. All spot samples tested with smear microscopy and Xpert MTB/Rif assay. Rifampicin resistant samples compared with conventional method. Results: Out of 1056 sputum samples GeneXpert MTB Rif assay detected positive 204 (19.3%), not detected 827 (78.31%). There is significant difference founded for positivity in spot samples and early morning sputum samples (P =0.0026). Rifampicins resistant were 8 (3.9%) andshown 100% sensitivity, specificity with Conventional method. Conclusion: For diagnosing tuberculosis and detecting Rifampicin resistance GeneXpert MTB/RIF has been especially recommended.

2019 ◽  
pp. 1-3
Author(s):  
B.V. Ramana* ◽  
A. Srikar ◽  
P. Prakash ◽  
Abhijit Chaudhury

Introduction: Tuberculosis is one of the oldest diseases with high morbidity and mortality. India accounts for one- fourth of the global TB burden (2.7million cases). Material and methods: A total 1056 patients were included in this study. All patients were requested to give two sputum samples, spot sputum sample (at the time of visit) and early morning sputum for mycobacterial testing. All spot samples tested with smear microscopy and Xpert MTB/Rif assay. Rifampicin resistant samples compared with conventional method. Results: Out of 1056 sputum samples GeneXpert MTB Rif assay detected positive 204 (19.3%), not detected 827 (78.31%). There is significant difference founded for positivity in spot samples and early morning sputum samples (P =0.0026). Rifampicins resistant were 8 (3.9%) andshown 100% sensitivity, specificity with Conventional method. Conclusion: For diagnosing tuberculosis and detecting Rifampicin resistance GeneXpert MTB/RIF has been especially recommended.


2017 ◽  
Vol 13 (1) ◽  
pp. 16-22
Author(s):  
Ashok Thapa ◽  
P Gurung ◽  
G R Ghimire

Introduction: Tuberculosis (TB) is one of the most deadly and common major infectious diseases in developing countries. Rapid and accurate diagnosis of tuberculosis is indispensable to adequately manage the disease and control its transmission. The objective of this study was to evaluate Gene Xpert MTB/RIF Assay for detection of M. tuberculosis in sputum of patients suspected of pulmonary tuberculosis and its comparison with traditional conventional methods.Methodology: A total of 138 patients sputum samples were collected and processed. Gene Xpert MTB/ RIF Assay, culture method and smear microscopy were performed under standard guideline inside biosafety cabinet class II. Data were reported, structured and analyzed using SPSS version 16.00. Study was carried out from June to November 2014.Results: Assay detected M. tuberculosis in 37 (26.81%) samples out of total 138. Of these 37, 10 and 3 were resistance and indeterminate to rifampicin respectively. Culture, Ziehl-Neelsen staining and Auramine staining were positive in 43 (31.16%), 18 (13.04%) and 24 (17.39%) samples respectively. Sensitivity, specificity, Positive predictive value and Negative predictive value of Assay were 76.74%, 95.79%, 89.19% and 90.09% respectively with reference to gold standard culture method.Conclusions: Assay was found rapid in direct detec tion of Mycobacterium tuberculosis in sputum sample and was also found more sensitive than both Ziehl-Neelsen staining and Auramine staining and especially showed good promise in diagnosis of smear negative specimens.SAARC J TUBER LUNG DIS HIV/AIDS, 2016; XIII(1), page: 16-22


2015 ◽  
Vol 2015 ◽  
pp. 1-6 ◽  
Author(s):  
Konjit Getachew ◽  
Tamrat Abebe ◽  
Abebaw Kebede ◽  
Adane Mihret ◽  
Getachew Melkamu

Background. Despite its lower sensitivity, smear microscopy remains the main diagnostic method for pulmonary tuberculosis (PTB) in resource-limited countries as TB culturing methods like LJ (Lowenstein-Jensen) are expensive to use as a routine base. This study aimed to evaluate the performance of LED-FM for the diagnosis of PTB in HIV positive individuals.Methods. Cross-sectional study was conducted in Zewditu Memorial Hospital and Teklehaimanot Health Center HIV/ART clinics in Addis Ababa, Ethiopia. Each sample was stained with ZN and Auramine O staining and examined with bright-field microscope and LED-FM microscope, respectively. LJ culture was used as a reference.Results. Out of 178 study participants, twenty-four (13.5%) patients were confirmed as positive for MTB with LJ culture. The yield of ZN microscopy and LED-FM in direct and concentrated sample was 3.9%, 8.4%, 6.2%, and 8.4%, respectively. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of direct ZN microscopy were 29.2%, 100%, 100%, and 90.1%, respectively, and of LED-FM microscopy in direct sputum sample were 62.5%, 100%, 100%, and 94.5%, respectively.Conclusion. LED-FM has better sensitivity for the diagnosis of PTB in HIV positive individuals as compared to conventional ZN microscopy. LED-FM can be used as an alternative to conventional ZN microscopy.


1970 ◽  
Vol 8 (2) ◽  
pp. 28-30
Author(s):  
J Kishan ◽  
P Kaur ◽  
A Mahajan ◽  
M Monika ◽  
K Navneet ◽  
...  

Introduction: Under the Revised National Tuberculosis Control Programme of India, three sputum samples are examined and 2 samples positivity criteria are used for labeling the patient as sputum positive pulmonary tuberculosis. Recent studies advocate use of two samples (one spot & one morning) for diagnosis of Tuberculosis. The objective was to compare three versus two sputum smears and to study the relevance of third sputum sample for microscopy in the current practice under Revised National Tuberculosis and Control Programme. Methodology: A study of the laboratory register of the designated microscopic centre for the calendar year 2008 was undertaken. In all 9028 suspects were examined. An analysis of contribution of various sputum samples, S1 (fi rst spot sample), M (early morning) & S2 (second spot) towards diagnosis of Pulmonary Tuberculosis was undertaken. Results: Sputum smear examination results of all the patients examined during 2008 were analyzed. Twelve hundred and eighty eight patients (99.3%) were labeled as smear positive tuberculosis when three sputum samples positivity criteria was considered. By applying two samples and any smear positivity criteria 1296 (99.9%) patients were labeled as sputum smear positive. Among 1296 smears, S1 was positive in 1088 (83.8%) and M in 1293 (99.6%) patients. Early morning sample positivity yield was found higher. Conclusion: Considering 2 samples for examination with at least one morning specimen and one sample positivity criteria, the work load on laboratory can be reduced by 1/3rd without affecting case detection rate. DOI: http://dx.doi.org/10.3126/saarctb.v8i2.5898 SAARCTB 2011; 8(2): 28-30


2020 ◽  
Vol 9 (3) ◽  
pp. 190-194
Author(s):  
Naureen Saeed ◽  
Fatima-tuz-zuhra ◽  
Nadeem Ikram ◽  
Farhana Shaukat ◽  
Fareeha Sardar

Background: Pakistan faces an immense burden of pulmonary tuberculosis (TB) due to large number of cases and limited resources. Despite the recent advancement in the diagnostic techniques for pulmonary TB, smear microscopy is still a useful technique for the diagnosis of this disease. This study was conducted in order to compare the diagnostic value of Auramine stain with the conventional Ziehl-Neelsen (ZN) stain on the sputum smear for the diagnosis of pulmonary TB, keeping GeneXpert MTB/RIF as the gold standard. Method: This cross-sectional study was conducted on 356 suspected patients of pulmonary TB referred to the Pathology laboratory from TB ward and OPD of District Head Quarter (DHQ) teaching hospital Rawalpindi, Pakistan. Sputum specimen were collected and two smears were prepared from each sputum sample on which Auramine phenol and Ziehl-Neelsen staining were carried out as per WHO recommendations. All these samples were further tested using Gene Xpert MTB/RIF technique. The sensitivity, specificity, Positive predictive value (PPV) and Negative predictive values (NPV) of ZN and Auramine stain were calculated and compared with GeneXpert MTB/RIF technique. Results: Out of the total 356 samples, 64(18%) were positive and 291(82%) were negative by GeneXpert which was taken as the gold standard. On comparison with GeneXpert, percentage of true positive was greater in case of Auramine than ZN stained samples (16.29% versus 12.92%), while the percentage of false positive was same for both staining techniques (0.28%). There were lesser false negative cases observed in samples stained by Auramine as compared to the ones stained by ZN (1.68% versus 5.05%). The sensitivity, specificity, positive predictive value and negative predictive values were 97.87%, 94.17%, 71.88 and 99.66%, respectively for the ZN staining and 98.31%, 97.98%, 90.63% and 99.66% respectively, for the Auramine phenol staining. Conclusion: Smear microscopy using Auramine phenol stain is a useful technique for the diagnosis of pulmonary TB. The Auramine phenol staining with fluorescent microscopy is found to be superior to ZN staining because of higher sensitivity and specificity. Keywords: Auramine phenol, Fluorescence microscopy, GeneXpert, Mycobacterium tuberculosis, Ziehl-Neelsen


2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S284-S285
Author(s):  
Bhavna Seth ◽  
John Bernardo ◽  
Carol Sulis

Abstract Background Patients suspected to have pulmonary tuberculosis (PTB) undergo serial sputum analysis under airborne infection isolation (AII). The US FDA approved the Cepheid GeneXpert-MTB-Rif® to support removing patients from AII. The FDA requires that “either one or two” separate sputum specimens be examined. To clarify this statement, the National Tuberculosis Controllers’ Association and the Association of Public Health Laboratories published guidelines that recommend that two sputum specimens be used and recommend that each institution examine their own data to determine whether one specimen is sufficient. Most patients in low prevalence settings do not have PTB yet are tested several times; an optimal testing strategy will reduce unnecessary isolation and related expenses. We sought to determine the diagnostic accuracy of a single vs. two sputum samples for Xpert MTB/RIF in discharging suspected PTB patients from AII. Methods Retrospective review of patients admitted between September 2016 to January 2018 was undertaken to identify sensitivity, specificity, positive and negative predictive values, for MTB gene Xpert in comparison to Mycobacterial culture as the gold standard. We further analyzed whether a larger number of such tests improved diagnostic yield for PTB. Results One hundred seventy-one patients, 17.5% of whom were HIV+, mostly of non-US origins (64%), provided 312 samples for Xpert MTB/RIF, of which 26 were Xpert-positive. These 26 samples came from 15 patients, 14 of whom were diagnosed using the first sample tested with Xpert MTB/RIF. Sensitivity and specificity of the first sample tested with Xpert MTB/RIF were more than those for the first two samples considered together or for all tested samples. Of these 15 positive cases, 13 were confirmed on sputum culture; 10 were positive from the first, one from the second, and two from the third sputum samples cultured. Conclusion Patients suspected to have PTB at our facility can be rapidly and accurately discharged from AII after testing a single sputum sample for MTB/RIF Xpert. Disclosures All authors: No reported disclosures.


2016 ◽  
Vol 54 (6) ◽  
pp. 1520-1527 ◽  
Author(s):  
Yap Boum ◽  
Soyeon Kim ◽  
Patrick Orikiriza ◽  
Carlos Acuña-Villaorduña ◽  
Solange Vinhas ◽  
...  

Sputum acid-fast bacilli (AFB) smear microscopy has suboptimal sensitivity but remains the most commonly used laboratory test to diagnose pulmonary tuberculosis (TB). We prospectively evaluated the small membrane filtration (SMF) method that concentrates AFB in a smaller area to facilitate detection to improve the diagnostic performance of microscopy. We enrolled adults with suspicion of pulmonary TB from health facilities in southwestern Uganda. Clinical history, physical examination, and 3 sputum samples were obtained for direct fluorescent AFB smear, SMF, Xpert MTB/RIF, and MGIT culture media. Sensitivity and specificity were estimated for SMF, AFB smear, and Xpert MTB/RIF, using MGIT as the reference standard. The analysis was stratified according to HIV status. From September 2012 to April 2014, 737 participants were included in the HIV-infected stratum (146 [20.5%] were culture positive) and 313 were in the HIV-uninfected stratum (85 [28%] were culture positive). In HIV-infected patients, the sensitivity of a single SMF was 67.4% (95% confidence interval [CI], 59.9% to 74.1%); for AFB, 68.0% (95% CI, 60.6% to 74.6%); and for Xpert MTB/RIF, 91.0% (95% CI, 85.0% to 94.8%). In HIV-uninfected patients, the corresponding sensitivities were 72.5% (95% CI, 62.1% to 80.9%), 80.3% (95% CI, 70.8% to 87.2%), and 93.5% (95% CI, 85.7% to 97.2%). The specificity for all 3 tests in both HIV groups was ≥96%. In this setting, the SMF method did not improve the diagnostic accuracy of sputum AFB. The Xpert MTB/RIF assay performed well in both HIV-infected and -uninfected groups.


Author(s):  
Banishree Pati ◽  
Rupa Vani K. ◽  
Gowri A. L. ◽  
Debendra Kumar Tripathy

Background: Abnormal vaginal bleeding may be caused by an extensive spectrum of disorders, both gynecologic and non-gynecologic. Diagnostic accuracy of abnormal uterine bleeding is important for the management.  Trans vaginal sonography (TVS) is one of the commonest investigation used for the diagnosis, but the diagnosis is not always accurate for all clinical conditions. Saline instillation sonography (SIS) has been shown to improve the diagnosis. Authors aimed to compare the TVS and SIS diagnosis with the final histopathological diagnosis.Methods: Seventy-five patients with the complained of abnormal uterine bleeding attending outpatient department of a tertiary care institute were enrolled for the study. Trans vaginal sonography (TVS) and saline instillation sonography (SIS) was done on outpatient basis. The diagnosis was compared with final histopathological diagnosis, in term of diagnostic accuracy, sensitivity, specificity, positive predictive value and negative predictive value.Results: Seventy-five patients who were enrolled for the study. Sixty-four patients underwent surgery and final histopathological diagnosis was established. Four patients SIS was not possible, data was analysed for sixty patients.Conclusions: In SIS abnormal uterus diagnosis confidence was significantly improved (p value 0.001) when compared to TVS. The diagnosis of submucous myoma significantly improved (p=0.015) by SIS when compared to TVS. There was no significant difference between TVS and SIS diagnosis of Myoma remote from the endometrium (p=0.522), Adenomyosis (p=1), Focal endometrial abnormality (p=0.654) and Diffuse endometrial abnormality (p=1). The SIS sensitivity, specificity, PPV and NPV were either improved or same, when compare to TVS for all the diagnosis except for the diagnosis of focal endometrial abnormality.


2018 ◽  
Vol 2018 ◽  
pp. 1-4 ◽  
Author(s):  
M. N. Wogu ◽  
F. O. Nduka

The World Health Organization’s policy on laboratory test of all suspected malaria cases before treatment has not yielded significant effects in several rural areas of Sub-Saharan Africa due to inadequate diagnostic infrastructure, leading to high morbidity and mortality rates. A cross-sectional randomized study was conducted to evaluate the validity of clinical malaria diagnosis through comparison with microscopy and rapid diagnostic test kits (RDTs) using 1000 consenting outpatients of a tertiary hospital in Nigeria. Physicians conducted clinical diagnosis, and blood samples were collected through venous procedure and analyzed for malaria parasites using Giemsa microscopy and RDT kits. Microscopy was considered the diagnostic “gold standard” and all data obtained were statistically analyzed using Chi-square test with aPvalue <0.05 considered significant. Malaria prevalence values of 20.1%, 43.1%, and 29.7% were obtained for clinical diagnosis, microscopy, and RDTs, respectively (P<0.05). Values of 47.2%, 95.9%, and 77.8% were obtained for sensitivity, specificity, and diagnostic accuracy, respectively, in clinical diagnosis, while RDTs had sensitivity, specificity, and diagnostic accuracy values of 73.7%, 97.3%, and 88.3%, respectively, when compared to microscopy (P<0.05). Clinical diagnosed malaria cases should be confirmed with a parasite-based laboratory diagnosis and more qualitative research is needed to explore why clinicians still use clinical diagnosis despite reported cases of its ineffectiveness.


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