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Girmay Medhin - One of the best experts on this subject based on the ideXlab platform.
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Sputum Smear positive pulmonary tuberculosis diagnostic dropout rate in public health facilities addis ababa ethiopia
Pulmonary Medicine, 2019Co-Authors: Daniel Melese Desalegn, Kumera Terfa Kitila, Boja Dufera Taddese, Tinsae Kidanemariam Hailu, Tariku Takle Dinku, Kassahun Demisse Asferie, Hanna Mekonnen Balcha, Chalachew Sisay Gebeyehu, Girmay MedhinAbstract:Background. Prolonged laboratory diagnostic process of tuberculosis can lead to failure to complete the diagnosis and increase dropout rate of Smear positive pulmonary tuberculosis (PTB) cases. This implies such dropout patients without completing diagnosis are critical as infected individuals remain untreated in the community, providing more opportunities for transmission of the disease and adversely affecting the epidemic. The aim of this research is to determine the level of Smear positive PTB diagnosis dropout rate of spot-morning-spot Sputum microscopy diagnosis method in public health facilities, in Addis Ababa, Ethiopia. Methods. Retrospective review of patient documents in 13 public health facilities’ TB laboratory in Addis Ababa was conducted from October 2011 to March 2016. Data was computerized using Epi-info software and analysed using SPSS version 20.0 software. Descriptive numerical summaries were used to present the findings. Association between the dropout rate and demographic variables was assessed by Chi-square (X2). Bivariate model using Odds Ratio (OR) with a 95% Confidence Interval (CI) was calculated. P-Value less than 0.05 was taken as statistically significant. Results. Of 41,884 presumptive TB patients registered during the 53 months for laboratory investigation, 5.9% were positive for the first spot Sputum Smear microscopy. Among these positive cases, 142 (5.8%) and 298 (12.1%) did not come back to the laboratory to submitted early morning and second spot Sputum specimens, respectively. The diagnostic dropout for morning Sputum specimen in hospitals was 5.6% (58/1039) and in health centres was 5.9% (84/1424). However, higher proportion of dropout for second spot Sputum specimen in hospitals was 16.4% (170/1039), compared to the health centres, 8.9% (128/1424). Diagnostic dropout of Sputum Smear microscopy had no significant association with sociodemographic variable (P value >0.05), while it had significant association with facility type (P value <0.05). Conclusion. In this study Smear positive pulmonary tuberculosis diagnostic dropout rate was high compared to WHO reported for the new strategy shift implying the importance of shifting to same-day approach. Hence, shifting from conventional to same day is crucial to minimize the TB diagnostic dropout rate in the study area and other similar settings. Further research is needed/recommended in the local setting to compare the yield and dropout rates between same-day and conventional Sputum Smear microscopy approach.
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Sputum Smear Positive Pulmonary Tuberculosis Diagnostic Dropout Rate in Public Health Facilities, Addis Ababa, Ethiopia
Hindawi Limited, 2019Co-Authors: Daniel Melese Desalegn, Kumera Terfa Kitila, Boja Dufera Taddese, Tinsae Kidanemariam Hailu, Tariku Takle Dinku, Kassahun Demisse Asferie, Hanna Mekonnen Balcha, Chalachew Sisay Gebeyehu, Girmay MedhinAbstract:Background. Prolonged laboratory diagnostic process of tuberculosis can lead to failure to complete the diagnosis and increase dropout rate of Smear positive pulmonary tuberculosis (PTB) cases. This implies such dropout patients without completing diagnosis are critical as infected individuals remain untreated in the community, providing more opportunities for transmission of the disease and adversely affecting the epidemic. The aim of this research is to determine the level of Smear positive PTB diagnosis dropout rate of spot-morning-spot Sputum microscopy diagnosis method in public health facilities, in Addis Ababa, Ethiopia. Methods. Retrospective review of patient documents in 13 public health facilities’ TB laboratory in Addis Ababa was conducted from October 2011 to March 2016. Data was computerized using Epi-info software and analysed using SPSS version 20.0 software. Descriptive numerical summaries were used to present the findings. Association between the dropout rate and demographic variables was assessed by Chi-square (X2). Bivariate model using Odds Ratio (OR) with a 95% Confidence Interval (CI) was calculated. P-Value less than 0.05 was taken as statistically significant. Results. Of 41,884 presumptive TB patients registered during the 53 months for laboratory investigation, 5.9% were positive for the first spot Sputum Smear microscopy. Among these positive cases, 142 (5.8%) and 298 (12.1%) did not come back to the laboratory to submitted early morning and second spot Sputum specimens, respectively. The diagnostic dropout for morning Sputum specimen in hospitals was 5.6% (58/1039) and in health centres was 5.9% (84/1424). However, higher proportion of dropout for second spot Sputum specimen in hospitals was 16.4% (170/1039), compared to the health centres, 8.9% (128/1424). Diagnostic dropout of Sputum Smear microscopy had no significant association with sociodemographic variable (P value >0.05), while it had significant association with facility type (P value
Stephen D Lawn - One of the best experts on this subject based on the ideXlab platform.
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diagnostic accuracy of a low cost urine antigen point of care screening assay for hiv associated pulmonary tuberculosis before antiretroviral therapy a descriptive study
Lancet Infectious Diseases, 2012Co-Authors: Stephen D Lawn, Andrew D Kerkhoff, Monica Vogt, Robin WoodAbstract:Summary Background The diagnostic accuracy of Sputum Smear microscopy and routine chest radiology for HIV-associated tuberculosis is poor, and culture-based diagnosis is slow, expensive, and is unavailable in most resource-limited settings. We assessed the diagnostic accuracy of a urine antigen test Determine TB-LAM Ag (Determine TB-LAM; Alere, Waltham, MA, USA) for screening for HIV-associated pulmonary tuberculosis before antiretroviral therapy (ART). Methods In this descriptive study, consecutive adults referred to a community-based ART clinic in Gugulethu township, South Africa, were all screened for tuberculosis by obtaining Sputum samples for fluorescence microscopy, automated liquid culture (gold-standard test), and Xpert MTB/RIF assays (Cepheid, Sunnyvale, CA, USA) and urine samples for the Clearview TB-ELISA (TB-ELISA; Alere, Waltham, MA, USA) and Determine TB-LAM test. Patients with Mycobacterium tuberculosis cultured from one or more Sputum samples were defined as cases of tuberculosis. The diagnostic accuracy of Determine TB-LAM used alone or combined with Sputum Smear microscopy was compared with that of Sputum culture and the Xpert MTB/RIF assay for all patients and subgroups of patients stratified by CD4 cell count. Findings Patients were recruited between March 12, 2010, and April 20, 2011. Of 602 patients enrolled, 542 were able to provide one or more Sputum samples, and 94 had culture-positive tuberculosis (prevalence 17·4%, 95% CI 14·2–20·8). Complete results from all tests were available for 516 patients (median CD4 count, 169·5 cells per μL; IQR 100–233), including 85 culture-positive tuberculosis, 24 of whom (28·2%, 95% CI 19·0–39·0) had Sputum Smear-positive disease. Determine TB-LAM test strips provided results within 30 min. Agreement was very high between two independent readers of the test strips (κ=0·97) and between the test strips and TB-ELISA (κ=0·84). Determine TB-LAM had highest sensitivity at low CD4 cell counts: 66·7% (95% CI 41·0–86·7) at Interpretation Determine TB-LAM is a simple, low-cost, alternative to existing diagnostic assays for tuberculosis screening in HIV-infected patients with very low CD4 cell counts and provides important incremental yield when combined with Sputum Smear microscopy. Funding Wellcome Trust.
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diagnostic accuracy of a low cost urine antigen point of care screening assay for hiv associated pulmonary tuberculosis before antiretroviral therapy a descriptive study
Lancet Infectious Diseases, 2012Co-Authors: Stephen D Lawn, Andrew D Kerkhoff, Monica Vogt, Robin WoodAbstract:Summary Background The diagnostic accuracy of Sputum Smear microscopy and routine chest radiology for HIV-associated tuberculosis is poor, and culture-based diagnosis is slow, expensive, and is unavailable in most resource-limited settings. We assessed the diagnostic accuracy of a urine antigen test Determine TB-LAM Ag (Determine TB-LAM; Alere, Waltham, MA, USA) for screening for HIV-associated pulmonary tuberculosis before antiretroviral therapy (ART). Methods In this descriptive study, consecutive adults referred to a community-based ART clinic in Gugulethu township, South Africa, were all screened for tuberculosis by obtaining Sputum samples for fluorescence microscopy, automated liquid culture (gold-standard test), and Xpert MTB/RIF assays (Cepheid, Sunnyvale, CA, USA) and urine samples for the Clearview TB-ELISA (TB-ELISA; Alere, Waltham, MA, USA) and Determine TB-LAM test. Patients with Mycobacterium tuberculosis cultured from one or more Sputum samples were defined as cases of tuberculosis. The diagnostic accuracy of Determine TB-LAM used alone or combined with Sputum Smear microscopy was compared with that of Sputum culture and the Xpert MTB/RIF assay for all patients and subgroups of patients stratified by CD4 cell count. Findings Patients were recruited between March 12, 2010, and April 20, 2011. Of 602 patients enrolled, 542 were able to provide one or more Sputum samples, and 94 had culture-positive tuberculosis (prevalence 17·4%, 95% CI 14·2–20·8). Complete results from all tests were available for 516 patients (median CD4 count, 169·5 cells per μL; IQR 100–233), including 85 culture-positive tuberculosis, 24 of whom (28·2%, 95% CI 19·0–39·0) had Sputum Smear-positive disease. Determine TB-LAM test strips provided results within 30 min. Agreement was very high between two independent readers of the test strips (κ=0·97) and between the test strips and TB-ELISA (κ=0·84). Determine TB-LAM had highest sensitivity at low CD4 cell counts: 66·7% (95% CI 41·0–86·7) at Interpretation Determine TB-LAM is a simple, low-cost, alternative to existing diagnostic assays for tuberculosis screening in HIV-infected patients with very low CD4 cell counts and provides important incremental yield when combined with Sputum Smear microscopy. Funding Wellcome Trust.
Karen R Steingart - One of the best experts on this subject based on the ideXlab platform.
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diagnostic accuracy of same day microscopy versus standard microscopy for pulmonary tuberculosis a systematic review and meta analysis
Lancet Infectious Diseases, 2013Co-Authors: Lucian J Davis, Philip C Hopewell, Adithya Cattamanchi, Luis E Cuevas, Karen R SteingartAbstract:Summary Background Sputum Smear microscopy is the most widely available diagnostic test for pulmonary tuberculosis in countries with a high burden of the disease. Improving its accuracy is crucial to achievement of case-detection targets established by the Millennium Development Goals. Unfortunately, many patients are unable to submit all of the specimens needed for examination or to return for treatment because standard Sputum collection and reporting requires several clinic visits. To inform policy recommendations by a WHO-convened Expert Group, we aimed to assess the accuracy of Sputum Smear examination with strategies for obtaining Sputum on 1 day compared with strategies for obtaining Sputum over 2 days. Methods We did a systematic review and meta-analysis of research articles comparing the accuracy of front-loaded or same-day microscopy and standard Sputum Smear microscopy for diagnosis of culture-confirmed pulmonary tuberculosis. We searched Medline, Embase, Biosis, and Web of Science for articles published between Jan 1, 2005, and Feb 14, 2012. Two investigators identified eligible articles and extracted data for individual study sites. We generated pooled summary estimates (95% CIs) for sensitivity and specificity by use of random-effects meta-analysis when four or more studies were available. Findings We identified eight relevant studies from five articles enrolling 7771 patients with suspected tuberculosis in low-income countries. Compared with the standard approach of examination of two Smears with Ziehl-Neelsen light microscopy over 2 days, examination of two Smears taken on the same day had much the same sensitivity (64% [95% CI 60 to 69] for standard microscopy vs 63% [58 to 68] for same-day microscopy) and specificity (98% [97 to 99] vs 98% [97 to 99]). We noted similar results for studies employing light-emitting diode fluorescence microscopy and for studies examining three Smears, whether they were compared with two-Smear strategies or with one another. Interpretation Same-day Sputum Smear microscopy is as accurate as standard Smear microscopy. Data from tuberculosis programmes are needed to document the changes required in the health system to successfully implement the strategy and understand its effects. Funding WHO and US National Institutes of Health.
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serological testing versus other strategies for diagnosis of active tuberculosis in india a cost effectiveness analysis
PLOS Medicine, 2011Co-Authors: David W Dowdy, Karen R Steingart, Madhukar PaiAbstract:Background: Undiagnosed and misdiagnosed tuberculosis (TB) drives the epidemic in India. Serological (antibody detection) TB tests are not recommended by any agency, but widely used in many countries, including the Indian private sector. The cost and impact of using serology compared with other diagnostic techniques is unknown. Methods and Findings: Taking a patient cohort conservatively equal to the annual number of serological tests done in India (1.5 million adults suspected of having active TB), we used decision analysis to estimate costs and effectiveness of Sputum Smear microscopy (US$3.62 for two Smears), microscopy plus automated liquid culture (mycobacterium growth indicator tube [MGIT], US$20/test), and serological testing (anda-tb ELISA, US$20/test). Data on test accuracy and costs were obtained from published literature. We adopted the perspective of the Indian TB control sector and an analysis frame of 1 year. Our primary outcome was the incremental cost per disability-adjusted life year (DALY) averted. We performed one-way sensitivity analysis on all model parameters, with multiway sensitivity analysis on variables to which the model was most sensitive. If used instead of Sputum microscopy, serology generated an estimated 14,000 more TB diagnoses, but also 121,000 more false-positive diagnoses, 102,000 fewer DALYs averted, and 32,000 more secondary TB cases than microscopy, at approximately four times the incremental cost (US$47.5 million versus US$11.9 million). When added to high-quality Sputum Smears, MGIT culture was estimated to avert 130,000 incremental DALYs at an incremental cost of US$213 per DALY averted. Serology was dominated by (i.e., more costly and less effective than) MGIT culture and remained less economically favorable than Sputum Smear or TB culture in one-way and multiway sensitivity analyses. Conclusions: In India, Sputum Smear microscopy remains the most cost-effective diagnostic test available for active TB; efforts to increase access to quality-assured microscopy should take priority. In areas where high-quality microscopy exists and resources are sufficient, MGIT culture is more cost-effective than serology as an additional diagnostic test for TB. These data informed a recently published World Health Organization policy statement against serological tests.
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Sputum monitoring during tuberculosis treatment for predicting outcome systematic review and meta analysis
Lancet Infectious Diseases, 2010Co-Authors: David J Horne, Philip C Hopewell, Payam Nahid, S Royce, Lisa Gooze, Masahiro Narita, Karen R SteingartAbstract:Summary WHO has previously recommended Sputum-Smear examination at the end of the second month of treatment in patients with recently diagnosed pulmonary tuberculosis, and, if positive, extension of the intensive therapy phase. We did a systematic review and meta-analysis to assess the accuracy of a positive Sputum Smear or culture during treatment for predicting failure or relapse in pulmonary tuberculosis. We searched PubMed, Embase, and the Cochrane Library for studies published in English through December, 2009. We included randomised controlled trials, cohort, and case-control studies of previously untreated pulmonary tuberculosis patients who had received a standardised regimen with rifampicin in the initial phase. Accuracy results were summarised in forest plots and pooled by use of a hierarchical regression approach. 15 papers (28 studies) met the inclusion criteria. The pooled sensitivities for both 2-month Smear (24% [95% CI 12–42%], six studies) and culture (40% [95% CI 25–56%], four studies) to predict relapse were low. Corresponding specificities (85% [95% CI 72–90%] and 85% [95% CI 77–91%]) were higher, but modest. For failure, 2-month Smear (seven studies) had low sensitivity (57% [95% CI 41–73%]) and higher, although modest, specificity (81% [95% CI 72–87%]). Both Sputum-Smear microscopy and mycobacterial culture during tuberculosis treatment have low sensitivity and modest specificity for predicting failure and relapse. Although we pooled a diverse group of patients, the individual studies had similar performance characteristics. Better predictive markers are needed.
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performance of purified antigens for serodiagnosis of pulmonary tuberculosis a meta analysis
Clinical and Vaccine Immunology, 2009Co-Authors: Karen R Steingart, Philip C Hopewell, Nandini Dendukuri, Megan Henry, Ian Schiller, Payam Nahid, Andrew Ramsay, Madhukar Pai, Suman LaalAbstract:Serological antibody detection tests for tuberculosis may offer the potential to improve diagnosis. Recent meta-analyses have shown that commercially available tests have variable accuracies and a limited clinical role. We reviewed the immunodiagnostic potential of antigens evaluated in research laboratories (in-house) for the serodiagnosis of pulmonary tuberculosis and conducted a meta-analysis to evaluate the performance of comparable antigens. Selection criteria included the participation of at least 25 pulmonary tuberculosis patients and the use of purified antigens. Studies evaluating 38 kDa, MPT51, malate synthase, culture filtrate protein 10, TbF6, antigen 85B, α-crystallin, 2,3-diacyltrehalose, 2,3,6-triacyltrehalose, 2,3,6,6′-tetraacyltrehalose 2′-sulfate, cord factor, and TbF6 plus DPEP (multiple antigen) were included in the meta-analysis. The results demonstrated that (i) in Sputum Smear-positive patients, sensitivities significantly ≥50% were provided for recombinant malate synthase (73%; 95% confidence interval [CI], 58 to 85) and TbF6 plus DPEP (75%; 95% CI, 50 to 91); (ii) protein antigens achieved high specificities; (iii) among the lipid antigens, cord factor had the best overall performance (sensitivity, 69% [95% CI, 28 to 94]; specificity, 91% [95% CI, 78 to 97]); (iv) compared with the sensitivities achieved with single antigens (median sensitivity, 53%; range, 2% to 100%), multiple antigens yielded higher sensitivities (median sensitivity, 76%; range, 16% to 96%); (v) in human immunodeficiency virus (HIV)-infected patients who are Sputum Smear positive, antibodies to several single and multiple antigens were detected; and (vi) data on seroreactivity to antigens in Sputum Smear-negative or pediatric patients were insufficient. Potential candidate antigens for an antibody detection test for pulmonary tuberculosis in HIV-infected and -uninfected patients have been identified, although no antigen achieves sufficient sensitivity to replace Sputum Smear microscopy. Combinations of select antigens provide higher sensitivities than single antigens. The use of a case-control design with healthy controls for the majority of studies was a limitation of the review. Efforts are needed to improve the methodological quality of tuberculosis diagnostic studies.
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optimizing Sputum Smear microscopy for the diagnosis of pulmonary tuberculosis
Expert Review of Anti-infective Therapy, 2007Co-Authors: Karen R Steingart, Andrew Ramsay, Madhukar PaiAbstract:The global burden of disability and death due to tuberculosis (TB) is immense. In 2005 alone, an estimated 8.8 million people developed TB and almost 2 million died, including 195,000 HIV-infected ...
Daniel Melese Desalegn - One of the best experts on this subject based on the ideXlab platform.
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Sputum Smear positive pulmonary tuberculosis diagnostic dropout rate in public health facilities addis ababa ethiopia
Pulmonary Medicine, 2019Co-Authors: Daniel Melese Desalegn, Kumera Terfa Kitila, Boja Dufera Taddese, Tinsae Kidanemariam Hailu, Tariku Takle Dinku, Kassahun Demisse Asferie, Hanna Mekonnen Balcha, Chalachew Sisay Gebeyehu, Girmay MedhinAbstract:Background. Prolonged laboratory diagnostic process of tuberculosis can lead to failure to complete the diagnosis and increase dropout rate of Smear positive pulmonary tuberculosis (PTB) cases. This implies such dropout patients without completing diagnosis are critical as infected individuals remain untreated in the community, providing more opportunities for transmission of the disease and adversely affecting the epidemic. The aim of this research is to determine the level of Smear positive PTB diagnosis dropout rate of spot-morning-spot Sputum microscopy diagnosis method in public health facilities, in Addis Ababa, Ethiopia. Methods. Retrospective review of patient documents in 13 public health facilities’ TB laboratory in Addis Ababa was conducted from October 2011 to March 2016. Data was computerized using Epi-info software and analysed using SPSS version 20.0 software. Descriptive numerical summaries were used to present the findings. Association between the dropout rate and demographic variables was assessed by Chi-square (X2). Bivariate model using Odds Ratio (OR) with a 95% Confidence Interval (CI) was calculated. P-Value less than 0.05 was taken as statistically significant. Results. Of 41,884 presumptive TB patients registered during the 53 months for laboratory investigation, 5.9% were positive for the first spot Sputum Smear microscopy. Among these positive cases, 142 (5.8%) and 298 (12.1%) did not come back to the laboratory to submitted early morning and second spot Sputum specimens, respectively. The diagnostic dropout for morning Sputum specimen in hospitals was 5.6% (58/1039) and in health centres was 5.9% (84/1424). However, higher proportion of dropout for second spot Sputum specimen in hospitals was 16.4% (170/1039), compared to the health centres, 8.9% (128/1424). Diagnostic dropout of Sputum Smear microscopy had no significant association with sociodemographic variable (P value >0.05), while it had significant association with facility type (P value <0.05). Conclusion. In this study Smear positive pulmonary tuberculosis diagnostic dropout rate was high compared to WHO reported for the new strategy shift implying the importance of shifting to same-day approach. Hence, shifting from conventional to same day is crucial to minimize the TB diagnostic dropout rate in the study area and other similar settings. Further research is needed/recommended in the local setting to compare the yield and dropout rates between same-day and conventional Sputum Smear microscopy approach.
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Sputum Smear Positive Pulmonary Tuberculosis Diagnostic Dropout Rate in Public Health Facilities, Addis Ababa, Ethiopia
Hindawi Limited, 2019Co-Authors: Daniel Melese Desalegn, Kumera Terfa Kitila, Boja Dufera Taddese, Tinsae Kidanemariam Hailu, Tariku Takle Dinku, Kassahun Demisse Asferie, Hanna Mekonnen Balcha, Chalachew Sisay Gebeyehu, Girmay MedhinAbstract:Background. Prolonged laboratory diagnostic process of tuberculosis can lead to failure to complete the diagnosis and increase dropout rate of Smear positive pulmonary tuberculosis (PTB) cases. This implies such dropout patients without completing diagnosis are critical as infected individuals remain untreated in the community, providing more opportunities for transmission of the disease and adversely affecting the epidemic. The aim of this research is to determine the level of Smear positive PTB diagnosis dropout rate of spot-morning-spot Sputum microscopy diagnosis method in public health facilities, in Addis Ababa, Ethiopia. Methods. Retrospective review of patient documents in 13 public health facilities’ TB laboratory in Addis Ababa was conducted from October 2011 to March 2016. Data was computerized using Epi-info software and analysed using SPSS version 20.0 software. Descriptive numerical summaries were used to present the findings. Association between the dropout rate and demographic variables was assessed by Chi-square (X2). Bivariate model using Odds Ratio (OR) with a 95% Confidence Interval (CI) was calculated. P-Value less than 0.05 was taken as statistically significant. Results. Of 41,884 presumptive TB patients registered during the 53 months for laboratory investigation, 5.9% were positive for the first spot Sputum Smear microscopy. Among these positive cases, 142 (5.8%) and 298 (12.1%) did not come back to the laboratory to submitted early morning and second spot Sputum specimens, respectively. The diagnostic dropout for morning Sputum specimen in hospitals was 5.6% (58/1039) and in health centres was 5.9% (84/1424). However, higher proportion of dropout for second spot Sputum specimen in hospitals was 16.4% (170/1039), compared to the health centres, 8.9% (128/1424). Diagnostic dropout of Sputum Smear microscopy had no significant association with sociodemographic variable (P value >0.05), while it had significant association with facility type (P value
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diagnostic yield of serial Sputum Smear microscopy examination at different institutional settings
Journal of Tropical Diseases & Public Health, 2018Co-Authors: Daniel Melese DesalegnAbstract:Introduction: Number of samples and time of Sputum collection has a great impact on the positivity yield of Sputum Smear microscopy examination. However, the impact is not yet extensively studied in Ethiopia. Therefore, the aim of this study was to assess the serials Sputum sample collection impacts on the diagnostic yield of Smear microscopy examination in Ethiopia at variation at different institutional settings. Methods: Institution based retrospective cohort study was conducted from October 2011 to March 2016. Two thousand four hundred sixty-three Sputum Smear microscopy positive result were reviewed from TB patient records. The collected data were computerized using Epi-info software and analyzed using SPSS version 20 software. Numerical summaries were used to describe the positivity yield of spot, morning and spot (SMS) Sputum Smear microscopy examination. Results: Of 2463 Sputum Smear-positive TB cases, 2384 (96.8%), 2458 (99.8%) and 2394 (97.2%) were detected by the first spot, morning and second spot Sputum Smear microscopy diagnosis, respectively. On the other hand, morning Sputum Smear results had the incremental yield of 74 (3.0%) and 64 (2.6%) from first spot sample and second spot sample, respectively. The results of 1892 (76.8%) TB cases were in agreement (detected) by three consecutive Sputum specimen (SMS). Conclusion: The three consecutive Sputum Smear microscopy examination had 3% incremental yield compare to spot-spot (SS). The hospitals were participating in International External Quality Assurance Schemes (IEQAS) had better incremental (increased) yield in both SMS and SS approach compared to the health centers. Hence, strong TB quality assurances systems should be implemented in respective health facilities before practicing two spots (SS) Sputum Smear microscopy diagnostic approach as routine to TB laboratory diagnostic method.
Robin Wood - One of the best experts on this subject based on the ideXlab platform.
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diagnostic accuracy of a low cost urine antigen point of care screening assay for hiv associated pulmonary tuberculosis before antiretroviral therapy a descriptive study
Lancet Infectious Diseases, 2012Co-Authors: Stephen D Lawn, Andrew D Kerkhoff, Monica Vogt, Robin WoodAbstract:Summary Background The diagnostic accuracy of Sputum Smear microscopy and routine chest radiology for HIV-associated tuberculosis is poor, and culture-based diagnosis is slow, expensive, and is unavailable in most resource-limited settings. We assessed the diagnostic accuracy of a urine antigen test Determine TB-LAM Ag (Determine TB-LAM; Alere, Waltham, MA, USA) for screening for HIV-associated pulmonary tuberculosis before antiretroviral therapy (ART). Methods In this descriptive study, consecutive adults referred to a community-based ART clinic in Gugulethu township, South Africa, were all screened for tuberculosis by obtaining Sputum samples for fluorescence microscopy, automated liquid culture (gold-standard test), and Xpert MTB/RIF assays (Cepheid, Sunnyvale, CA, USA) and urine samples for the Clearview TB-ELISA (TB-ELISA; Alere, Waltham, MA, USA) and Determine TB-LAM test. Patients with Mycobacterium tuberculosis cultured from one or more Sputum samples were defined as cases of tuberculosis. The diagnostic accuracy of Determine TB-LAM used alone or combined with Sputum Smear microscopy was compared with that of Sputum culture and the Xpert MTB/RIF assay for all patients and subgroups of patients stratified by CD4 cell count. Findings Patients were recruited between March 12, 2010, and April 20, 2011. Of 602 patients enrolled, 542 were able to provide one or more Sputum samples, and 94 had culture-positive tuberculosis (prevalence 17·4%, 95% CI 14·2–20·8). Complete results from all tests were available for 516 patients (median CD4 count, 169·5 cells per μL; IQR 100–233), including 85 culture-positive tuberculosis, 24 of whom (28·2%, 95% CI 19·0–39·0) had Sputum Smear-positive disease. Determine TB-LAM test strips provided results within 30 min. Agreement was very high between two independent readers of the test strips (κ=0·97) and between the test strips and TB-ELISA (κ=0·84). Determine TB-LAM had highest sensitivity at low CD4 cell counts: 66·7% (95% CI 41·0–86·7) at Interpretation Determine TB-LAM is a simple, low-cost, alternative to existing diagnostic assays for tuberculosis screening in HIV-infected patients with very low CD4 cell counts and provides important incremental yield when combined with Sputum Smear microscopy. Funding Wellcome Trust.
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diagnostic accuracy of a low cost urine antigen point of care screening assay for hiv associated pulmonary tuberculosis before antiretroviral therapy a descriptive study
Lancet Infectious Diseases, 2012Co-Authors: Stephen D Lawn, Andrew D Kerkhoff, Monica Vogt, Robin WoodAbstract:Summary Background The diagnostic accuracy of Sputum Smear microscopy and routine chest radiology for HIV-associated tuberculosis is poor, and culture-based diagnosis is slow, expensive, and is unavailable in most resource-limited settings. We assessed the diagnostic accuracy of a urine antigen test Determine TB-LAM Ag (Determine TB-LAM; Alere, Waltham, MA, USA) for screening for HIV-associated pulmonary tuberculosis before antiretroviral therapy (ART). Methods In this descriptive study, consecutive adults referred to a community-based ART clinic in Gugulethu township, South Africa, were all screened for tuberculosis by obtaining Sputum samples for fluorescence microscopy, automated liquid culture (gold-standard test), and Xpert MTB/RIF assays (Cepheid, Sunnyvale, CA, USA) and urine samples for the Clearview TB-ELISA (TB-ELISA; Alere, Waltham, MA, USA) and Determine TB-LAM test. Patients with Mycobacterium tuberculosis cultured from one or more Sputum samples were defined as cases of tuberculosis. The diagnostic accuracy of Determine TB-LAM used alone or combined with Sputum Smear microscopy was compared with that of Sputum culture and the Xpert MTB/RIF assay for all patients and subgroups of patients stratified by CD4 cell count. Findings Patients were recruited between March 12, 2010, and April 20, 2011. Of 602 patients enrolled, 542 were able to provide one or more Sputum samples, and 94 had culture-positive tuberculosis (prevalence 17·4%, 95% CI 14·2–20·8). Complete results from all tests were available for 516 patients (median CD4 count, 169·5 cells per μL; IQR 100–233), including 85 culture-positive tuberculosis, 24 of whom (28·2%, 95% CI 19·0–39·0) had Sputum Smear-positive disease. Determine TB-LAM test strips provided results within 30 min. Agreement was very high between two independent readers of the test strips (κ=0·97) and between the test strips and TB-ELISA (κ=0·84). Determine TB-LAM had highest sensitivity at low CD4 cell counts: 66·7% (95% CI 41·0–86·7) at Interpretation Determine TB-LAM is a simple, low-cost, alternative to existing diagnostic assays for tuberculosis screening in HIV-infected patients with very low CD4 cell counts and provides important incremental yield when combined with Sputum Smear microscopy. Funding Wellcome Trust.