Novel automated AIMLAM for diagnosis of Mycobacterium tuberculosis

Abstract

Aim: A rapid and precise diagnostic method is crucial for timely intervention and management of tuberculosis. The present study compared the diagnostic accuracy of a novel lipoarabinomannan (LAM) antigen test, AIMLAM, for tuberculosis in urine samples. Methodology: The study subjected 106 TB suspects to smear microscopy, MGIT, GeneXpert and AIMLAM. Results: Among 106, smear microscopy identified 36 as positive (33%) (sensitivity; 70.93%, 95% CI (60.14–80.22%), while MGIT showed 38 positive (36.8%). GeneXpert detected 59 positives (sensitivity; 96.83, 95% CI (89.00–99.61%)). AIMLAM declared 61 as positive (57.5%) (sensitivity; 100.00, 95% CI (94.13–100.00%) and 45 as negative (42.5%). Conclusion: Overall, AIMLAM demonstrated better diagnostic accuracy than GeneXpert Assay, smear microscopy and MGIT liquid culture in urine samples.

Plain language summary

This study describes a new way to detect tuberculosis, called AIMLAM. Unlike traditional methods that use sputum or blood, AIMLAM tests urine samples and bodily fluids. It is automated and uses easily accessible samples to identify a tuberculosis infection, so may be a convenient and noninvasive option for healthcare providers. The test shows promising results in terms of accuracy and sensitivity.

Summary points

• AIMLAM is an automated diagnostic system working on the principles of LAM detection in urine and other body fluid samples.

• The LAM in M. tuberculosis-specific cell wall is a key lipopolysaccharide excreted in the urine of TB patients.

• AIMLAM works through high-affinity monoclonal antibodies and chemiluminescent, detect LAM in urine and other body fluids, significantly enhances sensitivity and detection efficiency while maintaining high specificity.

• Monoclonal antibodies specific to LAM are conjugated to chemiluminescence for TB diagnosis.

• For TB diagnosis, four diagnostic approaches have been compared: GeneXpert Assay, MGIT culture, M. tuberculosis smear, and AIMLAM.

• 106 TB suspect samples were analyzed in six age groups with a male to female ratio of 1.86:1.

• Age group 5 had the maximum number of TB suspects (n = 28), followed by G4 (n = 27) and G2 (n = 18).

• Smear microscopy detected 36 (33%) positive, MGIT culture 38 (36.8%) positive, GeneXpert Assay 59 positive (Sensitivity; 96.83%), AIMLAM 61 positive (Sensitivity; 100.0%).

• AIMLAM's positivity is higher in males (40.6%) than females (17%).

• AIMLAM diagnostic test offers better diagnostic accuracy for M. tuberculosis in urine samples.

• It utilizes chemiluminescence detection, providing improved positivity rates and sensitivity.

• The technology is noninvasive, using urine and body fluid samples, making it advantageous and convenient for healthcare providers and patients.

• Especially beneficial for rapid TB detection across all age groups compared with other methods requiring sputum or blood samples.

• AIMLAM is time efficientt for reducing TB transmission time in the population.

Keywords: :

• AIMLAM
• lipoarabinomannan
• Mycobacterium tuberculosis
• TB

Author contributions

Conceptualization, writing original manuscript, resources: L Ruixia and L Jiankang, Reviewing, editing and visualization: S Hongmei, Data curation and methodology: W Han and Z Chang.

Financial disclosure

This study was supported by the Financial Support of Henan Tuberculosis Clinical Research Center. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Competing interests disclosure

The authors have no competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Writing disclosure

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

Ethical approval for the current study was obtained from the Henan Chest Hospital ethical board (No. (2023 (07-02)).

Acknowledgments

The authors are thankful for the technical support of the Zhongjing Research and Industrialization Institute of Chinese Medicine in Nanyang, China.