ArticleJournal of clinical microbiology2014
Rapid detection of isoniazid resistance in Mycobacterium tuberculosis isolates by use of real-time-PCR-based melting curve analysis.
Article in Journal of clinical microbiology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 1 of them a synthesis that pooled it.
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Who cites it
27 citing papers in PubMed, 1 synthesis or guideline pooled it, 48 citations in OpenAlex.
- Systematic Review of Mutations Associated with Isoniazid Resistance Points to Continuing Evolution and Subsequent Evasion of Molecular Detection, and Potential for Emergence of Multidrug Resistance in Clinical Strains of Mycobacterium tuberculosis.Antimicrobial agents and chemotherapy · 2021Pooled it
- An evaluation of Innowave MTB/RIF/INH assay versus Xpert MTB/RIF for rapid identification ofMicrobiology spectrum · 2026Article
- Epidemiologic and clinical characteristics ofFrontiers in cellular and infection microbiology · 2026Article
- A novel one-tube nested fluorescence melting curve analysis for rapid detection of drug-resistant Mycobacterium tuberculosis.BMC microbiology · 2025Article
- Application of engineered CRISPR/Cas12a variants with altered protospacer adjacent motif specificities for the detection of isoniazid resistance mutations inMicrobiology spectrum · 2025Article
- Improved detection of isoniazid-heteroresistantMicrobiology spectrum · 2025Article
- Innowave MTB/RIF/INH facilitates timely and accurate diagnosis of multiple-drug resistant tuberculosis as a near POCT technique: a multicenter prospective on-site performance evaluation study.Annals of clinical microbiology and antimicrobials · 2025Article
- TheAntimicrobial agents and chemotherapy · 2025Article
- Risk factors for poor outcomes in patients with drug-resistant tuberculosis: a 6-year multicenter prospective study in Zhejiang, China.BMC infectious diseases · 2025Article
- Post-liver transplantation bacterial infection: current status, prevention and treatment.Frontiers in cellular and infection microbiology · 2025Review
- L-DNA-Based Melt Analysis Enables Within-Sample Validation of PCR Products.Analytical chemistry · 2024Article
- Evaluation of MeltPro Assay in Identification of Second-Line Injectable Drug Resistance in Multidrug-Resistant Tuberculosis Isolates.Infection and drug resistance · 2024Article
- Identification ofInfection and drug resistance · 2024Review
- Performance of the MeltPro TB assay as initial test for diagnosis of pulmonary tuberculosis with drug-resistance detection.Molecular medicine (Cambridge, Mass.) · 2023Article
- Quantification of Isoniazid-Heteroresistant Mycobacterium tuberculosis Using Droplet Digital PCR.Journal of clinical microbiology · 2023Article
- Highly Sensitive Detection of Isoniazid Heteroresistance inInfection and drug resistance · 2022Article
- Fluoroquinolone heteroresistance, antimicrobial tolerance, and lethality enhancement.Frontiers in cellular and infection microbiology · 2022Review
- A Recombinase Polymerase Amplification-Coupled Cas12a Mutant-Based Module for Efficient Detection of Streptomycin-Resistant Mutations inFrontiers in microbiology · 2021Article
- Rapid Detection of Ethambutol-ResistantInfection and drug resistance · 2020Article
- Diagnostic accuracy evaluation of the conventional and molecular tests for Spinal Tuberculosis in a cohort, head-to-head study.Emerging microbes & infections · 2018Article
Corrections and comments
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Authors and funding
10 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The MeltPro TB/INH assay, recently approved by the Chinese Food and Drug Administration, is a closed-tube, dual-color, melting curve analysis-based, real-time PCR test specially designed to detect 30 isoniazid (INH) resistance mutations in katG position 315 (katG 315), the inhA promoter (positions -17 to -8), inhA position 94, and the ahpC promoter (positions -44 to -30 and -15 to 3) of Mycobacterium tuberculosis. Here we evaluated both the analytical performance and clinical performance of this assay. Analytical studies with corresponding panels demonstrated that the accuracy for detection of different mutation types (10 wild-type samples and 12 mutant type samples), the limit of detection (2×10(3) to 2×10(4) bacilli/ml), reproducibility (standard deviation [SD], <0.4°C), and the lowest heteroresistance level (40%) all met the parameters preset by the kit. The assay could be run on five types of real-time PCR machines, with the shortest running time (105 min) obtained with the LightCycler 480 II. Clinical studies enrolled 1,096 clinical isolates collected from three geographically different tuberculosis centers, including 437 INH-resistant isolates and 659 INH-susceptible isolates characterized by traditional drug susceptibility testing on Löwenstein-Jensen solid medium. The clinical sensitivity and specificity of the MeltPro TB/INH assay were 90.8% and 96.4%, respectively. DNA sequencing analysis showed that, except for the 5 mutants outside the detection range of the MeltPro assay, a concordance rate between the two methods of 99.1% (457/461) was obtained. Among the 26 mutation types detected, katG S315T (AGC→ACC), inhA -15C→T, katG S315N (AGC→AAC), and ahpC promoter -10C→T accounted for more than 90%. Overall, the MeltPro TB/INH assay represents a reliable and rapid tool for the detection of INH resistance in clinical isolates.
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