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MIC-based tuberculosis drug susceptibility testing using Sensititre MYCOTB: a diagnostic accuracy meta-analysis.

Accurate drug susceptibility testing (DST) is crucial for designing effective regimens for multidrug-resistant (MDR) and pre-extensively drug-resistant tuberculosis (pre-XDR TB). Sensititre MYCOTB enables simultaneous determination of minimum inhibitory concentrations (MICs) for multiple drugs, but its diagnostic performance varies across studies. This meta-analysis evaluated the diagnostic performance of Sensititre MYCOTB for key MDR and pre-XDR TB drugs. The protocol was registered in PROSPERO (CRD420251230599). PubMed, Cochrane, Google Scholar, Scopus, ONOS, Web of Science, ScienceDirect, and registries were systematically searched for studies published between 2010 and 2025. Studies comparing the Sensititre MYCOTB with reference DST for Mycobacterium tuberculosis complex (MTBC) were included. Bias assessment and pooled diagnostic accuracy estimates were generated. Fourteen studies, including 1,728 isolates, were analyzed. Rifampicin and isoniazid demonstrated high sensitivity (0.976 [95% CI: 0.94-0.99] and 0.977 [95% CI: 0.95-0.99]) and specificity (0.958 [95% CI: 0.84-0.98] and 0.957 [95% CI: 0.83-0.99], respectively) with low heterogeneity. Amikacin, kanamycin, and ofloxacin demonstrate good diagnostic accuracy, with high specificity (>0.98 [95% CI]). Moderate diagnostic accuracy was observed for ethambutol, streptomycin, ethionamide, and rifabutin. Cycloserine, moxifloxacin, and para-aminosalicylic acid showed inconsistent performance despite excellent specificity (>0.97 [95% CI]). Sensitivity analysis partially improved pooled sensitivity for moxifloxacin 0.801 (95% CI: 0.585-0.924) and para-aminosalicylic acid 0.76 (95% CI: 0.518-0.894), whereas cycloserine remained at 0.436 (95% CI: 0.190-0.725), although heterogeneity persisted. Sensititre MYCOTB DST demonstrates high diagnostic accuracy for MDR-TB and pre-XDR-TB drugs, while caution is required with cycloserine, moxifloxacin, and para-aminosalicylic acid. These findings support the integration of MIC-based testing into clinical decision-making.

Microbial Sensitivity Tests↗

Dexamethasone suppression test: a review of contemporary confusion.

Reasons for the current controversy and confusion about the dexamethasone suppression test (DST) are reviewed, and basic axioms regarding use and interpretation of the test are reiterated. Problems with reliability and validity of current diagnostic systems limit their use as "gold standards" for evaluating the DST; accurate evaluation must await follow-up and treatment response studies. Interpretation of DST results in specific patients requires common sense, consideration of the clinical context, and attention to technical factors. While its ultimate significance is not yet known, the DST, like other laboratory tests, may help to resolve uncertainty in clinical diagnosis. Perhaps most important, it may help to refine current paradigms for psychiatric nosology and diagnosis.

Acute Disease↗

[External quality assessment of drug susceptibility testing for Mycobacterium tuberculosis].

OBJECTIVE: The Committee for Mycobacterial Examinations has planned and implemented the third external quality assessment of drug susceptibility testing for Mycobacterium tuberculosis to the hospital and private laboratories. METHOD: The Committee delivered 20 M. tuberculosis strains, exactly pairs of 10 strains, which were evaluated and standardized for the drug resistance pattern in the WHO/ IUATLD supra-national laboratory network (SRLN). The agreement of the majority of SRLN laboratories was considered as the gold standard of susceptibility result for each strain tested. Each laboratory performed the drug susceptibility testing (DST) with its own routine method. The sensitivity to detect drug resistance, the specificity for susceptible strain, the efficiency of overall agreement, the reproducibility for each pair, and kappa coefficient were calculated to evaluate their performance. DST was performed for isoniazid (INH), rifampicin (RFP), streptomycin (SM) and ethambutol (EB). RESULTS: A total of 48 results has been collected. The overall sensitivity, specificity, efficiency, reproducibility and kappa coefficient for each anti-tuberculosis drug tested were as follows respectively; 100%, 99.0% (62.5-100), 99.6% (85.0-100), 99.6% (90-100) and 0.991 for INH; 97.7% (83.3-100), 100%, 98.6% (90-100), 99.0% (90-100) and 0.972 for RFP; 87.5% (66.7-100), 99.0% (87.5-100), 92.1% (80-100), 97.5% (70-100) and 0.84 for SM; 99.5% (75.0-100), 97.9% (75.0-100), 98.5% (85.0-100), 97.9% (70-100) and 0.97 for EB. Regarding private laboratories, all indicators showed 100% for INH but 2 hospital laboratories showed less than 90% in sensitivity. As for RFP, one private laboratory (4.3%) and 3 hospital laboratories showed less than 90% in sensitivity. The major difference between private and hospital laboratories was seen in EB. One hospital laboratory (4.0%) showed less than 90% in sensitivity and three (12.0%) showed less than 90% in specificity, compared to none in private laboratories. Additionally, six hospital laboratories (24.0%) showed less than 90% in reproducibility. As for quality improvement, two private laboratories that showed poor performance in 2003 have improved their quality up to 100% in 2004. DISCUSSION: The overall efficiency by private and hospital laboratories satisfied WHO criteria. However, it diverged in each category of laboratories and hospital laboratories tended to show poor performance compared to the private ones. The reason for the difference was not clear, but the routine workload, allocated time and cost for the panel testing might contribute to it. The sensitivity of SM was relatively low compared to the other drugs as it was observed in 2003. It was mainly due to two strains to which the participating laboratories showed poor agreement to the gold standard. The difference of critical drug concentration for SM in Löwenstein-Jensen and in 1% Ogawa medium might contribute to the discrepancies. As for quality improvement, two private laboratories with poor performance in 2003 have shown marked improvement after on-site evaluation. The results indicated the usefulness of external quality assessment for the maintenance and improvement of the quality of the test.

Laboratories, Hospital↗

Surveillance of anti-tuberculosis drug resistance: results of the 1998/1999 proficiency testing in Italy. SMIRA (Italian Multicentre Study on Antituberculosis Drug Resistance) Study Group.

OBJECTIVE: To determine the accuracy of drug-susceptibility testing (DST) for isoniazid, rifampicin, ethambutol and streptomycin in a provisional network of 22 regional laboratories in Italy. METHODS: Methods, definitions and reference Mycobacterium tuberculosis strains were derived from the WHO/IUATLD Global Project on Anti-tuberculosis Drug Resistance Surveillance. The laboratories were selected based on technical skills required by the project, the number of DST performed annually and geographic localisation. The results (sensitive/resistant strain) were compared with the gold standard (global project results). Sensitivity (ability to detect true resistance), specificity (ability to detect true susceptibility), positive predictive values for resistance and susceptibility, efficiency and reproducibility were calculated in two rounds. RESULTS: Eighteen of 22 laboratories completed the first round of proficiency testing for the four drugs. Sensitivity was 76.6%, specificity 97.2%, predictive value of a resistant test 89.8% and of a susceptible test 86.8%, efficiency 87.8% and reproducibility 92.8%. A second round was performed by all those laboratories that did not achieve > or = 90% agreement with the results of the Global Project. Overall, after the second round, all the parameters except specificity improved, exceeding 90%. CONCLUSIONS: A network of 15 regional laboratories that fulfil the quality criteria for determining the susceptibility of M. tuberculosis to the four primary antituberculosis drugs was established in Italy.

Antitubercular Agents↗

Representative drug susceptibility patterns for guiding design of retreatment regimens for MDR-TB.

BACKGROUND: There is no gold standard on how national tuberculosis programs should design retreatment regimens. Often drug susceptibility testing (DST) is not available for all patients, and representative DST patterns in patient populations are used to guide therapy. OBJECTIVES: To examine DST patterns in different patient populations based on previous treatment and to estimate the number of effective anti-tuberculosis agents in several retreatment regimens. METHODS: We reviewed DST results from patients treated with individualized regimens in Peru between January 1998 and July 2004. We stratified patients into four groups based on previous treatment exposure from Group 1 who had failed only one regimen to Group 4 who had failed three regimens. We compared resistance frequencies across the four groups. In Groups 1 and 3, the number of likely effective agents under six possible retreatment regimen scenarios was estimated. RESULTS: Resistance to second-line drugs was significantly higher in groups with more previous courses of treatment. A few retreatment regimens could be identified that would allow at least 80% of patients to receive at least four likely effective drugs. CONCLUSION: Because it is associated with resistance frequencies, previous treatment exposure can serve to guide the design of non-individualized MDR-TB regimens.

Adult↗

Evaluation of mycobacteria growth indicator tube for direct and indirect drug susceptibility testing of Mycobacterium tuberculosis from respiratory specimens in a Siberian prison hospital.

The manual Mycobacteria Growth Indicator Tube (MGIT) method was evaluated for performing direct and indirect drug susceptibility testing (DST) of Mycobacterium tuberculosis for isoniazid and rifampin on 101 strongly smear-positive sputum specimens in a Siberian prison hospital. Using the indirect method of proportion (MOP) as the "gold standard," the accuracies of isoniazid and rifampin susceptibility testing by the direct MGIT system were 97.0 and 94.1%, respectively. The accuracy of the indirect MGIT system was 98.0% for both drugs. The turnaround times from specimen processing to reporting of the DST results ranged between 4 and 23 (mean, 9.2) days by the direct MGIT method, 9 and 30 (mean, 15.3) days by the indirect MGIT method, and 26 and 101 (mean, 59.6) days by the indirect MOP. MGIT appears to be a reliable, rapid, and convenient method for performing direct and indirect DSTs in low-resource settings, but further studies are required to refine the direct DST protocol. Cost is the only factor prohibiting widespread implementation of MGIT.

Antitubercular Agents↗

[Normality tables in the Spanish population for psychometric tests used in the diagnosis of minimal hepatic encephalopathy].

BACKGROUND AND OBJECTIVE: Minimal hepatic encephalopathy (MHE) induces an impairment in the quality of life and has been found as the first stage in hepatic encephalopathy syndrome. Psychometric Hepatic Encephalopathy Score (PHES) is a psychometric test battery widely utilized in the diagnosis of MHE which requires correction by age and education. POPULATION AND METHOD: Eight-hundred and eighty four healthy people were included. Trailmaking test-A (TMT-A), TMT-B, digit symbol test (DST), serial dotting (SDT) and line drawing test (LDT) were performed. Age, education, gender, alcohol consumption and hospitalization were recorded. T-student and Pearson correlation were utilized in univariate analyses. A multiple linear regression was performed to detect independent variables associated with psychometric test score. Using the equation from the multiple linear regression, normality tables were built. RESULTS: Age and education were associated with all 5 tests. An alcohol consumption higher than 10 g per day was associated with a lower score in DST and SDT. A gender influence was seen in TMT-A and TMT-B. Moreover, some differences were found in SDT, TMT-B and LDT according to hospital procedence. In multivariate analyses using multiple linear regression, age and education were independently associated with all five tests. CONCLUSIONS: Normality tables of the PHES allow investigating MHE in cirrhotics avoiding local control groups. Taking in mind normality tables, PHES could become a gold standard test to analyze further diagnostic methods and to evaluate drugs efficacy in MHE. Normality tables are freely available at http://www.redEH.org.

Adult↗

API TB Consensus Guidelines 2006: Management of pulmonary tuberculosis, extra-pulmonary tuberculosis and tuberculosis in special situations.

INTRODUCTION: The World Health Organization (WHO) has declared Tuberculosis (TB) a global emergency in 1993. Prevalence of TB and Human Immunodeficiency Virus (HIV) co-infection worldwide is 0.18% and about 8% TB cases have HIV infection. Effective chemotherapy has been available for treatment of TB for over 50 years now. In World Health Organization (WHO)-International Union Against Tuberculosis and Lung Disease (IUATLD) Working Group Global Anti-Tuberculosis Drug Resistance Surveillance (1994-1997), the incidence of MDR TB in Delhi was found to be 14%, of which primary multi-drug resistance was only 1.4%, indicating that most of MDR TB is acquired as a result of poor chemotherapy. DIAGNOSIS OF TB: Since TB is an infectious disease caused by Mycobacterium (M) tuberculosis the diagnosis of TB should (as far as possible) be by demonstration of M. tuberculosis on culture or acid-fast bacilli (AFB) on smear examination. The World Health Organization (WHO) has strongly recommended sputum smear examination as the preferred screening test and suggests examination of 3 deeply coughed out sputum samples - spot sample on day 1, overnight sample and a spot sample in the morning on day 2. Recently it has been shown that sputum smear positivity is greater than 90% where greater than 5 ml of sputum is used for smear diagnosis of pulmonary TB. Culture of M. tuberculosis is the gold standard for diagnosis of TB. Culture of mycobacteria is a much more sensitive test than smear examination and has been estimated to detect 10-100 viable mycobacteria per ml of sample and in case of active disease they are found to be 81% sensitive and 98.5% specific. Culture methods are also required for further drug sensitivity testing in cases of suspected drug resistant cases. Isoniazid and rifampicin resistance can be reliably measured; resistance to pyrazinamide, ethambutol, and streptomycin is more difficult due to limitations of technique. The therapeutic index for a given drug is low for certain second-line drugs such as ethionamide, cycloserine, viomycin and para amino salicylic acid (PAS) and it leads to misinterpretation of results due to failure to distinguish between sensitive and resistant strains. Misdiagnosis of MDR-TB due to laboratory related errors has been reported recently. MANAGEMENT OF TB: Chemotherapy of TB consists of prevention of infection, also called primary chemoprophylaxis, when isoniazid 5 mg/kg is given to prevent infection in newborn infants of infectious mothers till mother is sputum smear positive (2-3months). Treatment of latent tuberculosis, also called secondary chemoprophylaxis, when isoniazid 5 mg/kg is given for 6 months to prevent disease in infected persons (asymptomatic MT positive individuals) and treatment of disease with Short Course Chemotherapy (SCC), as per WHO categories. Essential anti-tuberculosis (ATT) drugs Isoniazid (H), Rifampicin (R), Ethambutol (E), Pyrazinamide (Z) and Streptomycin (S) are the essential first line anti-tuberculosis drugs. Anti TB regimen consists of two phases: an initial intensive phase (IIP) and a continuation phase (CP). Best effective SCC for treatment of TB, for adults and children, for pregnant and lactating females, for cases associated with diabetes mellitus and HIV infection, for cases with pre-existing liver diseases (but normal liver functions) and mild renal failure is 2EHRZ, 4HR given daily or thrice weekly. Higher dose SCC intermittent therapy given in thrice weekly (2E3H3R3Z3, 4H3R3) has now been advocated by WHO and implemented by the Revised National TB Control Programme. DOTS, directly observed therapy short course, where the patient takes the drugs under the direct observation (DO) of a health worker to ensure regularity of consumption of drugs. Fixed dose combinations (FDCs) drugs consisting of two or three antituberculosis medications, provide a realistic and welcome alternative to DO that minimizes the opportunity for a patient to selectively take only a single medication. MANAGEMENT OF TB IN SPECIAL SITUATIONS: Pregnancy: All drugs, that is, rifampicin, isoniazid, ethambutol, and pyrazinamide can be used during pregnancy. Streptomycin is not given due to ototoxicity to the fetus. Prophylactic pyridoxine in the dose of 10mg/day is recommended along with ATT. Diabetes mellitus: The drug regimen is same as in nondiabetic. Strict control of blood glucose is mandatory. Also, doses of oral hypoglycemic agents may have to be increased due to interaction with Rifampicin. Prophylactic pyridoxine is indicated. Renal failure: Dosages may have to be adjusted according to the creatinine clearance especially for streptomycin, ethambutol and isoniazid. In acute renal failure, ethambutol should be given 8 hours before hemodialysis. In post renal transplant patients: Rifampicin-containing regimens are avoided as rifampicin causes increased clearance of cyclosporin. Pre-existing liver disease: In stable disease with normal liver enzymes, all anti-tuberculous drugs may be used but frequent monitoring of liver function tests is required. Treatment in unconscious patient (patients unable to swallow): If patients are fed by Ryle's tube or gastrostomy tube, usual doses and drugs may be powdered and administered avoiding feeds 2-3 hours before and after the dose. In cases where enterostomy has been performed or parenteral nutrition is being used, intramuscular streptomycin and isoniazid and intravenous quinolones may be used and switch to oral therapy once oral feed resume. Treatment of TB with HIV co-infection: In early stages the presentations of TB in TB-HIV co-infection is the same as HIV negative but in late stages extra-pulmonary and dissemination are common. The usual short course chemotherapy is indicated in HIV positive patients. The response is usually good but relapse is frequent. After initiating ATT or anti-retroviral therapy (ART) worsening of preexisting lesions or appearance of new lesions is seen, "paradoxical response" or "immune reconstitution phenomenon". Multidrug resistant TB can occur due to poor compliance to ATT due to behavioural pattern, increased incidence of side effects and malabsorption of drugs due to associated diarrhea. ART for HIV, containing protease inhibitors (PI) and non-nucleoside reverse transcriptase inhibitors (NNRTI) cannot be used along with R, as R induces metabolism of PI and reduces the efficacy. The various options are i) to postpone anti-retroviral therapy ii) to use no PI or NNRTI containing anti-retroviral combinations iii) to use certain PI/ and/or NNRTIs with modification in doses iv) Efavirenz (EFZ) or Saquinavir with Ritonavir, without the need to adjust the doses v) to use non R regimens e.g. 2SHEZ+10HE MANAGEMENT OF MDR TB: As far as possible treatment of MDR TB should be referred to specialized units with facilities for quality controlled DST and experienced in handling such cases. If such referrals are not possible, one must remember that while initiating or revising therapy for MDR-TB, drugs selection must rely on prior treatment history, results of susceptibility testing and an evaluation of the patient's adherence.

Algorithms↗