Quality indicators in a mycobacteriology laboratory supporting clinical trials for pulmonary tuberculosis

Selvakumar, N; Silambuchelvi, K.; Sekar, M Gomathi; Sunder, Ashok; Anbarasu, S.; Rekha, V. Banu; C, George Priya Doss; Kumar, Vanaja

doi:10.1016/j.ijmyco.2012.09.004

Cited by 5 publications

(3 citation statements)

References 7 publications

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“…The high (91%) culture positive rate in AFB smear positive sputum obtained in this study may be due to the fact that samples were transported in cold chain and processed within the acceptable time limit in a high quality laboratory. Our culture positive rate is higher than the 85% rate reported by Selvakumar et al, (28) in India and close to the 100% rate reported by Simeon et al, (29).…”

Section: Discussionsupporting

confidence: 71%

Phenotypic characterization of mycobacteria isolates from tuberculosis patients in Kaduna State, Nigeria

Ahmadu¹,

Olonitola²,

Suleiman³

et al. 2019

Af J Clin Exp Micro

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Background: Tuberculosis (TB) remains one of the leading public health challenges in Nigeria and the burden is still high. There is hence a need for continuous characterization of mycobacteria to obtain current data that will aid the ongoing TB prevention and control programme. The aim of this study was to phenotypically characterize mycobacteria isolates recovered from clinical specimens of patients with tuberculosis in Kaduna State, Nigeria. Methods: Two thousand, two hundred and twelve (2212) sputum samples were collected from patients clinically suspected to have TB in three different zones of Kaduna State, Nigeria, between May 2017 and October, 2018. Samples were processed by decontaminating with NaOH-Citrate N-acetyl-L-Cystein method for Ziehl Neelsen (ZN) AFB microscopy and culture on Lowenstein Jensen (LJ) slants which were incubated at 37 ᵒ C for 8 weeks. Positive LJ cultures were further analyzed with a rapid TB antigen assay (SD-Bioline) to differentiate Mycobacterium tuberculosis complex (MTBC) from Non Tuberculous Mycobacteria (NTM). Results: Out of the 2212 patients with suspected TB, 300 (13.6%) were positive for AFB by microscopy with Zone A (Kaduna North) having the highest AFB positive cases of 169 (15.2%). Of the 300 AFB positive samples, 272 (91.0%) were culture positive on LJ medium, 18 (6.0%) were culture negative and 10 (3.0%) were culture contaminated. Result of the distribution of mycobacteria among infected patients within the study area revealed that 219 (80.5%) were infected with MTBC, 42 (15.4%) with NTM and 11 (4.0%) with both MTBC and NTM. Conclusion: A relatively high number of TB in the study area was caused by NTM. There is need for advanced diagnostic tools that can differentiate MTBC and NTM strains among TB patients in all TB Reference Laboratories in Nigeria.

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Section: Discussionsupporting

confidence: 71%

Phenotypic characterization of mycobacteria isolates from tuberculosis patients in Kaduna State, Nigeria

Ahmadu¹,

Olonitola²,

Suleiman³

et al. 2019

Af J Clin Exp Micro

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“…For TB culture test, the quality indicators have been comprehensively reported in different mycobacteriology laboratories [8–10]; however, quality indicators for Xpert MTB/RIF assessment was made in Ethiopia and thus was not yet reported. We implemented the quality indicators recommended for Xpert MTB/RIF at the National TB Reference Laboratory (NTRL) of Ethiopia.…”

Section: Introductionmentioning

confidence: 99%

Monitoring quality indicators for the Xpert MTB/RIF molecular assay in Ethiopia

et al. 2019

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IntroductionIn Ethiopia, >300 GeneXpert instruments have been deployed for tuberculosis (TB) testing using the Xpert MTB/RIF cartridge. Implementing quality indicators is necessary for monitoring and evaluating the quality of Xpert MTB/RIF diagnostic services.ObjectiveTo assess the use of quality indicators for the Xpert MTB/RIF molecular assay in Ethiopia and to compare the findings with the predefined targets described in the literature.MethodsClinical specimens collected from patients with suspected TB were subjected to Xpert MTB/RIF testing at the National TB Reference Laboratory (NTRL) between January and December 2018. Data were collected from GeneXpert software and Laboratory Information System (LIS) databases. Quality indicators were calculated and analyzed. Bivariate and multivariate analyses were performed using SPSS software version 20 (SPSS Inc., Chicago, Illinois, USA).ResultsOf the 2515 specimens tested, 2274 (90.4%) had successful test results; 18.2% were positive for Mycobacterium tuberculosis (MTB). Among MTB positives (n = 413), 4.8% and 1.0% were rifampicin (RIF)-resistant and RIF-indeterminate cases, respectively. Unsuccessful results were 241 (9.6%); 8.9% of the total number of tests were errors, 0.04% had invalid results and 0.6% ‘no result’. The most frequent error was probe check failure (error 5007). Instrument module A4, B2, B3, C3, and D3 (p<0.05) and tester experience (p<0.05) had a statistically significant association with errors in multivariate analysis. Additional 42 MTB cases (9.2% of the total cases) were detected among unsuccessful results by follow-up tests. Sixty-four percent of the initial test results were released within the turnaround time (TAT) ≤24 hours.ConclusionMost of the quality indicators for the Xpert MTB/RIF molecular assay were maintained within the targets. However, the error rate and TAT were out of the targets. Defective modules and lacking experience were the factors affecting successful test outcomes.

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“…Standard performance indicators for TB culture laboratories [ 17 , 18 ] were also calculated and interpreted on a weekly, monthly, and quarterly basis for continuous quality improvement projects. Here, results from January 2010 to December 2012 are presented.…”

Section: Resultsmentioning

confidence: 99%

Feasibility of establishing a biosafety level 3 tuberculosis culture laboratory of acceptable quality standards in a resource-limited setting: an experience from Uganda

Ssengooba

Gelderbloem

Mboowa

et al. 2015

Health Res Policy Sys

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BackgroundDespite the recent innovations in tuberculosis (TB) and multi-drug resistant TB (MDR-TB) diagnosis, culture remains vital for difficult-to-diagnose patients, baseline and end-point determination for novel vaccines and drug trials. Herein, we share our experience of establishing a BSL-3 culture facility in Uganda as well as 3-years performance indicators and post-TB vaccine trials (pioneer) and funding experience of sustaining such a facility.MethodsBetween September 2008 and April 2009, the laboratory was set-up with financial support from external partners. After an initial procedure validation phase in parallel with the National TB Reference Laboratory (NTRL) and legal approvals, the laboratory registered for external quality assessment (EQA) from the NTRL, WHO, National Health Laboratories Services (NHLS), and the College of American Pathologists (CAP). The laboratory also instituted a functional quality management system (QMS). Pioneer funding ended in 2012 and the laboratory remained in self-sustainability mode.ResultsThe laboratory achieved internationally acceptable standards in both structural and biosafety requirements. Of the 14 patient samples analyzed in the procedural validation phase, agreement for all tests with NTRL was 90% (P <0.01). It started full operations in October 2009 performing smear microscopy, culture, identification, and drug susceptibility testing (DST). The annual culture workload was 7,636, 10,242, and 2,712 inoculations for the years 2010, 2011, and 2012, respectively. Other performance indicators of TB culture laboratories were also monitored. Scores from EQA panels included smear microscopy >80% in all years from NTRL, CAP, and NHLS, and culture was 100% for CAP panels and above regional average scores for all years with NHLS. Quarterly DST scores from WHO-EQA ranged from 78% to 100% in 2010, 80% to 100% in 2011, and 90 to 100% in 2012.ConclusionsFrom our experience, it is feasible to set-up a BSL-3 TB culture laboratory with acceptable quality performance standards in resource-limited countries. With the demonstrated quality of work, the laboratory attracted more research groups and post-pioneer funding, which helped to ensure sustainability. The high skilled experts in this research laboratory also continue to provide an excellent resource for the needed national discussion of the laboratory and quality management systems.Electronic supplementary materialThe online version of this article (doi:10.1186/1478-4505-13-4) contains supplementary material, which is available to authorized users.

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Quality indicators in a mycobacteriology laboratory supporting clinical trials for pulmonary tuberculosis

Abstract: Values of quality indicators in mycobacteriology laboratories supporting exclusively clinical trials of PTB have to be defined and used for meaningful monitoring of laboratories.

Cited by 5 publications

References 7 publications

Phenotypic characterization of mycobacteria isolates from tuberculosis patients in Kaduna State, Nigeria

Phenotypic characterization of mycobacteria isolates from tuberculosis patients in Kaduna State, Nigeria

Monitoring quality indicators for the Xpert MTB/RIF molecular assay in Ethiopia

Feasibility of establishing a biosafety level 3 tuberculosis culture laboratory of acceptable quality standards in a resource-limited setting: an experience from Uganda

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