Tuberculosis Diagnostic Methods: Clinical Applicability, Implementation Challenges, and Integrated Testing Strategies

Area of Science:

• Microbiology
• Infectious Diseases
• Public Health

Background:

• Tuberculosis (TB) is a leading infectious cause of death globally, worsened by HIV and drug resistance.
• Existing diagnostic methods for TB vary in applicability and impact across different healthcare settings.
• There's a need for practical, implementation-focused reviews of TB diagnostics.

Purpose of the Study:

• To provide a comprehensive overview of laboratory diagnostic methods for active and latent TB.
• To emphasize clinical applicability, implementation challenges, and integration within diagnostic strategies.
• To adopt an implementation-oriented perspective, considering real-world constraints and regional disparities.

Main Methods:

• Review of conventional methods (smear microscopy, culture) and modern technologies (NAATs, LAMP, LPAs, NGS, lateral flow assays).
• Critical examination of diagnostic methods based on real-world constraints, regional disparities, and evidence gaps.
• Integration of WHO guidance with contextual and operational considerations.

Main Results:

• Strengths and limitations of various TB diagnostic methods are highlighted in different contexts.
• Implementation challenges including infrastructure, biosafety, workforce, and sustainability are discussed.
• Under-addressed areas like latent TB and co-pathogen investigation are considered.

Conclusions:

• Rational test selection and integrated diagnostic workflows are crucial for strengthening TB strategies.
• Tailoring diagnostic approaches to local health system capacity and patient populations is essential for effectiveness and equity.
• This review supports informed decision-making for TB diagnostic implementation worldwide.