Research and Development Tracker for Chinese Manufactured TB In‑vitro Diagnostics

Introduction

In recent years, China has made rapid advancement in biomedical technology R&D. Many of these innovations have revolutionized TB in‑vitro diagnostics (IVD). A number of innovative TB diagnostic and screening products that are novel in mechanism and accurate in performance have been successfully developed by Chinese IVD manufacturers. Evidence from domestic clinical evaluation and operational studies carried out under programmatic conditions have demonstrated that these novel TB IVDs are either on par or close to the thresholds outlined by the latest WHO Target Product Profiles (WHO TPPs). Some of these IVD products have demonstrated their versatility in processing sample types other than sputum, most notably the tongue swabs.

In order to systematically introduce Chinese developed TB IVD technologies and products to the world. The Innovation Alliance on Tuberculosis Diagnosis and Treatment has been working closely with many of the leading IVD companies and startups in China on evidence generation (both diagnostic performance and their health economics), advocacy for WHO IVD PQ and tracking on the progress of their R&D as well as regulatory status. As of August 2026, IATB brings 10 TB IVD products' latest specs and status in a format compatible with the WHO TPPs to the tracker with updates taking place every six months.

Product Name	Diagnostic Performance	Regulatory Status	WHO TB IVD Categories	Target Population and Usage	Operational Characteristics
Coyote FlashDetect™ LyocartE MTB Assay	Analytical Sensitivity (LOD): 10 CFU/mL Clinical Sensitivity: Sputum 98.95%; Tongue Swab 89.20% Clinical Specificity: Sputum 98.69%; Tongue Swab 86.97% Multiplexing: Targets IS6110 and IS1081 genes; internal control	CE‑IVD marked Manufactured under ISO 13485 quality systems and GMP standards	NPOC	Individuals suspected of pulmonary tuberculosis Intended users: Laboratory professionals and trained healthcare workers	Sample types: Sputum or Tongue Swabs Sample prep: Liquefaction (~1 min) for sputum; direct swab transfer for swabs Time to result: <30 minutes (sonication: 2 min) Throughput: Nano 1–16; Ultra 1–32 (Ultra with built‑in sonicator) Setting: Near‑POC, clinics, and community screening Power: Supports external mobile power supply options Operating environment: 10–40°C; 50–80% humidity Reagent transport: Room temperature Shelf life: 12 months at 2–28°C
Coyote FlashDetect™ LyocartE MTB&RIF Assay	Analytical Sensitivity (LOD): 10 CFU/mL Clinical Sensitivity/Specificity: Under development Multiplexing: Targets IS6110, IS1081, and the 81bp RRDR of the rpoB gene; sample processing control; internal control	CE‑IVD marked Manufactured under ISO 13485 quality systems and GMP standards	NPOC	Individuals suspected of TB or at high risk for MDR‑TB or RR‑TB Intended users: Medical professionals or trained operators proficient in molecular testing	Sample types: Sputum Sample prep: Liquefaction (~1 min) Time to result: 60 minutes (sonication: 2 min) Throughput: Nano 1–16; Ultra 1–32 (Ultra with built‑in sonicator) Setting: Frontline healthcare and district hospitals Power: Supports external mobile power supply options Operating environment: 10–40°C; 50–80% humidity Reagent transport: Room temperature Shelf life: 12 months at 2–28°C
Coyote FlashDetect™ LyocartE MTB/RIF&INH Assay	Analytical Sensitivity (LOD): MTB 10 CFU/mL; RIF & INH 300 CFU/mL Clinical Sensitivity/Specificity: Under development Multiplexing: Targets MTBC, RIF (rpoB), and INH (katG, inhA, ahpC); sample processing control; internal control	CE‑IVD marked Manufactured under ISO 13485 quality systems and GMP standards	NPOC	Individuals with suspected or confirmed pulmonary TB, or those at high risk for MDR‑TB Intended users: Laboratory professionals, healthcare workers, or trained medical staff proficient in molecular testing	Sample types: Sputum Sample prep: Liquefaction (~1 min) Time to result: 60 minutes Throughput: High‑throughput matrix with 1 to 32 scalable modules Setting: Near‑POC Power: Supports external mobile power supply options Operating environment: 10–40°C; 50–80% humidity Reagent transport: Room temperature Shelf life: 12 months at 2–28°C
Autobio TB‑IGRA CLIA Microparticles	Sensitivity: 97.84% Specificity: 98.25% Method: Fully automated chemiluminescent microparticle immunoassay (CLIA Microparticles) Antigens: ESAT‑6 and CFP‑10 specific antigens Detection: Qualitative detection of Mycobacterium tuberculosis specific T cell immune response Detects both latent TB infection (LTBI) and active TB infection Unaffected by BCG vaccine interference	CE marked Manufactured by Autobio Diagnostics Co., Ltd. ISO9001 and EN ISO13485 certified manufacturer	Immunodiagnostic test (IGRA) for TB infection detection	Individuals suspected of TB infection (latent or active tuberculosis) For screening of LTBI and active TB Intended users: Laboratory professionals and trained healthcare workers Platform: AutoLumo Series automated CLIA analyzers	Sample type: Fresh peripheral venous anticoagulant whole blood Sample collection: Negative pressure tube design for easier sample collection/ Sterile blood collection tubes (lithium heparin or sodium heparin) Sample prep: Whole sample pre‑treatment in the same tube; direct loading into analyzer Sample management: Test on arrival; no need to wait for batch accumulation Sample Release Reagent: Included for sample processing Sample storage before incubation: ≤24 hours (optimal) Incubation: 37°C, 16–24 hours (recommended 18h), vertical Centrifugation: 1800–3000g, 10 minutes Detection time: First result in 34 minutes Total process time (28 samples): ~22 hours (including incubation) Throughput: S900 Series ‑ 60 samples/h; A1800 Series ‑ 60 samples/h; A2000Plus Series – 40 samples/h; (Continuous Sample Loading) A6000 Series – 150 samples/h (fully loaded)(Continuous Sample Loading) Automation: Fully automated on AutoLumo Series analyzers Global footprint: >10 million patients tested across >25 countries
Shengting Medical TBseq®	Sensitivity: 90.9% on various sample types (Yu et al.). Specificity: 93.0% on various sample types (Yu et al.).	CE‑IVD. NMPA in progress. ISO9001 and EN ISO13485 certified manufacturer	Next gen‑sequencing for drug resistance to MTB	Target population: Clinically suspected of having pulmonary tuberculosis or at increased risk of TB. Intended users: Trained users working in laboratory.	Multiplexing: Identifies 168 species of mycobacteria. Sample types: BALF, sputum, tissue, Pus, CSF, pleural effusion, ascites. Manual prep of samples: 100 minutes. Time to result: Less than 12 hours. Throughput per test: 96 sample max per run. POC or near POC: POC. Power requirement: Compatible analyzer. Operation environment: 20–26 ℃, RH 30%–70%. Reagent kits transport: ‑20℃ (cold chain required). Shelf life: 12 months.
Shengting Medical Lungseq®	Sensitivity: 95% (internal laboratory validation). Specificity: 99% (internal laboratory validation).	N/A	Next gen‑sequencing for drug resistance to MTB	Intended purpose: Detection of 637 bacterial species, 345 fungal species, 24 atypical pathogens, 174 mycobacterial species; analyzes DNA methylation, lung cancer‑associated gene mutations, and human‑derived copy number variations (CNVs). Target population: Individuals with imaging findings suggestive of lung cavities, requiring differentiation between malignant and infectious lung cavities, complex etiology, or low‑biomass microbial infections. Intended users: Trained users working in laboratory.	Multiplexing: Detects 637 bacterial species, 345 fungal species, 24 atypical pathogens, 174 mycobacterial species, DNA methylation, lung cancer mutations, CNVs. Sample types: BALF, lung tissue, pleural/ascitic fluid. Manual prep of samples: 100 minutes. Time to result: Less than 12 hours. Throughput per test: 96 sample max per run. POC or near POC: POC. Power requirement: Compatible analyzer. Operation environment: 20–26 ℃, RH 30%–70%. Reagent kits transport: ‑20℃ (cold chain required). Shelf life: 12 months.
Rocgene iFIND TBR Assay	LOD: MTB 13.34 CFU/mL; RIF-R 109.79 CFU/mL Clinical performance (vs WHO-recommended molecular assays): • Sensitivity: MTB 98.55% (613/622); RIF 95.58% (108/113) • Specificity: MTB 92.76% (282/304); RIF 97.37% (370/380) Method: Nested real-time fluorescence PCR with molecular beacon melting-curve analysis Targets: IS6110, IS1081; rpoB RRDR (81-bp)	CE‑IVD marked; NMPA (China) approved Manufacturing quality system: ISO 9001 and ISO 13485	NPOC, LC‑aNAATs for initial MTB/RIF detection	Persons evaluated for suspected pulmonary or extrapulmonary TB, including pediatric presentations Intended users: Trained laboratory professionals or trained healthcare workers in laboratory or near-point-of-care settings	Sample types: Sputum (sputum sediment, BALF, pleural fluid, ascites, pus, CSF, gastric aspirate, urine, stool, tissue, bacterial isolates also validated)  Sample prep: Liquefaction(~15 min) Time to result: ≤120min from sample loading  Throughput:  iFIND S2 / S4 / S8 with 2 / 4 / 8 fully independent modules Setting:laboratory or near-point-of-care settings Power supply: AC 100–240 V (±10%), 50/60 Hz Shelf life: 12months at 2–28 °C
Rocgene iFIND IFQ Assay	LOD: INH 20.79 CFU/mL; FQ 9.34 CFU/mL Clinical performance (vs phenotypic DST): • Sensitivity: INH-R 94.17% (194/206); FQ 93.15% (136/146) • Specificity: INH 98.02% (595/607); FQ 98.20% (655/667) Method: Nested real-time fluorescence PCR with molecular beacon melting-curve analysis Targets: katG, inha; gyrA	CE‑IVD marked; NMPA (China) approved Manufacturing quality system: ISO 9001 and ISO 13485	NPOC, LC‑aNAATs for INH and FQ resistance testing (MTBC‑positive specimens)	Patients with MTBC-positive specimens or isolates requiring INH and FQ resistance assessment, including RR/MDR-TB cases prior to regimen selection Intended users: Trained laboratory professionals or trained healthcare workers in laboratory or near-point-of-care settings	Sample types: Sputum (sputum sediment, BALF, pleural fluid, ascites, pus, CSF, gastric aspirate, urine, stool, tissue, bacterial isolates also validated)  Sample prep: Liquefaction(~15 min) Time to result: ≤150min from sample loading  Throughput:  iFIND S2 / S4 / S8 with 2 / 4 / 8 fully independent modules Setting:laboratory or near-point-of-care settings Power supply: AC 100–240 V (±10%), 50/60 Hz Shelf life: 12months at 2–28 °C
Hugo Biotech's TB‑EASY Kit	Sensitivity: Tongue swab： • Compared to sputum Xpert MTB/RIF: 89.6% • Compared to microbiological reference standard: 87.4% Sputum (under evaluation) Specificity: Tongue swab: • Compared to sputum Xpert MTB/RIF: 96.2% • Compared to microbiological reference standard: 98.0% Sputum (under evaluation)	NMPA and CE, only for tongue swabs. Manufacturing facility in line with ISO 13485 and ISO 14971	MC‑aNAATs for initial diagnosis of MTBC	Intended use case: The TB‑EASY Kit is primarily designed for the detection of tuberculosis (TB) in both tongue swabs and sputum specimens, enabling rapid and accurate tuberculosis diagnosis. The product is open‑platform so it can cover all application scenarios especially primary medical institutions. It can detect 48 samples within 4 hours and be adapted to automation. In this case TB‑EASY can be used in screening or diagnosis. Target population: • Adults and adolescents (over 10 years) in need of evaluation for TB • Populations and groups at risk of TB Intended user: professional users, laboratory technicians, or healthcare workers with training in conducting moderately complex lab tests in laboratory settings.	Sample types: tongue swabs, Sputum. Manual prep of samples: 1. Place the sampling tube into the dry bath for incubation 2. Take the sample for beads beating 3. Place the tube into the EASYLab for DNA extraction and PCR mix preparation 4. After the process is completed, seal the PCR plate manually. 5. Put the plate on the PCR machine for qPCR detection. TAT: < 4 hours. Throughput per test: 48 samples Multiplexing: compatible on open PCR platforms, such as Quantistudio 5/7, ABI7500, SLAN‑95S, etc. Power requirement: continuous electrical power. Operation environment: 2 ℃ to 40 ℃ with up to 50% humidity. Reagent kits transport:2 ℃ to 40 ℃ ; No cold chain required. Shelf life: 12 months at 2 ℃ to 40 ℃ with up to 85% humidity.
Hugo Biotech's TB‑Pro Assay	Sensitivity: Compared with WGS results >95% Specificity: Compared with WGS results >98%	Research use only. Manufacturing facility in line with ISO 13485 and ISO 14971	Next gen‑sequencing for drug resistance to MTB	Intended use case: The TB Pro Assay addresses these critical gaps by combining multiplex PCR targeted amplification with next‑generation sequencing (NGS) technology. Designed for use with a wide range of clinical samples, including sputum, bronchoalveolar lavage fluid (BALF), blood, and cerebrospinal fluid (CSF), etc., TB Pro delivers accurate species‑level identification and relative quantification of MTB and NTM, alongside the detection of mutations in TB drug‑resistant genes. This comprehensive approach supports precise anti‑infection therapy, positioning TB Pro as an indispensable tool for diagnosing TB, particularly drug‑resistant TB. By providing rapid, reliable, and actionable insights, TB Pro empowers clinicians to optimize treatment strategies, improve patient outcomes, and combat the growing threat of drug‑resistant tuberculosis.	Sample types: sputum, bronchoalveolar lavage fluid (BALF), blood, and cerebrospinal fluid (CSF), culture isolates etc. TAT: ≤24hrs Reagent transport and storage: cold chain required, ‑15℃ ~ ‑25℃ Shelf life: 12 months