Diagnostic Accuracy of the INSHI Consensus Case De?nition for theDiagnosis of Paradoxical Tuberculosis-IRIS.

Background: The diagnosis of paradoxical tuberculosis--associated immune reconstitution inflammatory syndrome (TB-IRIS) relies on characteristic clinical features synthesized as the International Network for the Study of HIV-associated IRIS (INSHI) case definition. There is no confirmatory laboratory test. Setting: Site B HIV-TB clinic in Khayelitsha, Cape Town, South Africa. Methods: Using data of participants with HIV-associated tubercu- losis starting antiretroviral treatment from a prospective trial evaluating prednisone for TB-IRIS prevention, we applied latent class analysis to model a gold standard for TB-IRIS. The model- predicted probability of TB-IRIS for each participant was used to assess the performance of the INSHI case definition and compare its diagnostic accuracy with several adapted case definitions. Results: Data for this analysis were complete for 217 participants; 41% developed TB-IRIS. Our latent class model included the following parameters: respiratory symptoms; night sweats; INSHI major criteria 1, 2, and 4; maximum C-reactive protein .90 mg/L; maximum heart rate .120/min; maximum temperature .37.7°C; and preantiretroviral therapy CD4 count,50 cells/mL. The model estimated a TB-IRIS incidence of 43% and had optimal goodness of fit(χ² = 337, P = 1.0). The INSHI case definition displayed a sensitivity of 0.77 and a specificity of 0.86. Replacing all the minor INSHI criteria with objectives measures (C-reactive protein eleva- tion, fever, and/or tachycardia) resulted in a definition with better diagnostic accuracy, with a sensitivity of 0.89 and a specificity of 0.88. Conclusion: The INSHI case definition identifies TB-IRIS with reasonable accuracy. Amending the case definition by replacing INSHI minor criteria with objective variables improved sensitivity without loss of specificity. [ABSTRACT FROM AUTHOR]