Diagnostic Accuracy of the INSHI Consensus Case Definition for the Diagnosis of Paradoxical Tuberculosis-IRIS.

Abstract

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 tuberculosis 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/µL. 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 elevation, 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.

• Authors: Cari Stek, Jozefien Buyze, Joris Menten, Charlotte Schutz, Friedrich Thienemann, Lisette Blumenthal, Gary Maartens, Tom Boyles, Robert J Wilkinson, Graeme Meintjes, Lutgarde Lynen
• Journal: Journal of acquired immune deficiency syndromes (1999) (J Acquir Immune Defic Syndr) Vol. 86 Issue 5 Pg. 587-592 (04 15 2021) ISSN: 1944-7884 [Electronic] United States
• PMID: 33394813 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc.

Chemical References

• Anti-HIV Agents

Topics

• Adult
• Anti-HIV Agents (therapeutic use)
• Consensus
• Female
• HIV Infections (drug therapy, prevention & control)
• Humans
• Immune Reconstitution Inflammatory Syndrome
• Male
• Prospective Studies
• South Africa
• Tuberculosis (diagnosis, drug therapy)