Diagnosis of tuberculosis in an Indian population by an indirect ELISA protocol based on detection of Antigen 85 complex: a prospective cohort study
2007

Diagnosing Tuberculosis with an Indirect ELISA Test

Sample size: 197 publication Evidence: high

Author Information

Author(s): Kashyap Rajpal S, Rajan Anju N, Ramteke Sonali S, Agrawal Vijay S, Kelkar Sanjivani S, Purohit Hemant J, Taori Girdhar M, Daginawala Hatim F

Primary Institution: Central India Institute of Medical Sciences, Nagpur

Hypothesis

Can the Ag 85 complex in serum be reliably detected in tuberculosis patients using an indirect ELISA method?

Conclusion

The indirect ELISA method for detecting Ag 85 complex in TB patient sera provides a reliable diagnosis with high sensitivity and specificity.

Supporting Evidence

  • The indirect ELISA method showed 82% sensitivity and 86% specificity for TB diagnosis.
  • Ag 85 complex was detected in 96% of confirmed TB cases and 79% of clinically diagnosed cases.
  • Only 14% positivity was found in the non-tuberculosis group.

Takeaway

This study shows that a simple blood test can help doctors find out if someone has tuberculosis by looking for a specific protein in their blood.

Methodology

Indirect ELISA was used to detect Ag 85 complex in serum samples from TB patients and controls.

Limitations

The study may not account for false positives from other mycobacterial diseases.

Participant Demographics

128 active TB patients (81 male, 47 female; age 13–63 years) and 69 non-TB controls.

Statistical Information

P-Value

p<0.001

Confidence Interval

95% CI [67 to 93%] for sensitivity; 95% CI [57 to 98%] for specificity

Statistical Significance

p<0.001

Digital Object Identifier (DOI)

10.1186/1471-2334-7-74

Want to read the original?

Access the complete publication on the publisher's website

View Original Publication