Ju Young Lee1, Sun-Mi Kim1, Su-Jin Park1, Sang-Oh Lee1, Sang-Ho Choi1, Yang Soo Kim1, Jun Hee Woo1, Sung-Han Kim2. 1. Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. 2. Department of Infectious Diseases, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. Electronic address: kimsunghanmd@hotmail.com.
Abstract
OBJECTIVES: A recently developed RD-1 gene-based assay for diagnosing tuberculous peritonitis (TBP) has given promising results. We therefore created a clinical algorithm for differentiating TBP from other diagnoses using peripheral blood and peritoneal fluid mononuclear cells (PBMC/PF-MC) along with conventional tests. METHODS: All adult patients with suspected TBP in whom enzyme-linked immunosorbent spot (ELISPOT) assays were performed both on PBMC and PF-MC were prospectively enrolled over a 6-year period. Confirmed TBP with positive cultures or Mycobacterium tuberculosis PCR, probable TBP with PF changes consistent with TBP, caseating granuloma, and a successful response to anti-TB therapy, as well as possible TBP without exclusion of TBP, were each defined. RESULTS: A total of 74 patients were enrolled. Of these, 45 (61%) (19 confirmed, 16 probable, and 10 possible) were classified as TBP. The other 29 (39%) patients were classified as not TB. The sensitivity and specificity, respectively, of the tested methods for diagnosing TBP were as follows: PBMC ELISPOT (≥6 spots), 84% and 59%; PF-MC ELISPOT (≥6 spots), 87% and 86%; PF-MC/PBMC ratio (≥3), 69% and 97%; and PF-ADA level (≥21 U/L), 82% and 79%. The areas under the ROC curves were as follows: PF-MC ELISPOT, 0.90; PF-MC/PBMC ratio, 0.82; PBMC ELISPOT, 0.80; and PF-ADA, 0.80, respectively. When a 2-step algorithm ('PBMC ELISPOT ≥6 spots or PF-ADA ≥21 U/L' as a rule-out test and 'PF-MC/PBMC ratio ≥3' as a rule-in test) was applied, 67% (30/45) of the patients with TBP were accurately classified without undergoing invasive procedures. CONCLUSIONS: A 2-step algorithm using the PBMC/PF-MC ELISPOT assays and PF-ADA appears to be a promising rapid and non-invasive approach for diagnosing TBP.
OBJECTIVES: A recently developed RD-1 gene-based assay for diagnosing tuberculous peritonitis (TBP) has given promising results. We therefore created a clinical algorithm for differentiating TBP from other diagnoses using peripheral blood and peritoneal fluid mononuclear cells (PBMC/PF-MC) along with conventional tests. METHODS: All adult patients with suspected TBP in whom enzyme-linked immunosorbent spot (ELISPOT) assays were performed both on PBMC and PF-MC were prospectively enrolled over a 6-year period. Confirmed TBP with positive cultures or Mycobacterium tuberculosis PCR, probable TBP with PF changes consistent with TBP, caseating granuloma, and a successful response to anti-TB therapy, as well as possible TBP without exclusion of TBP, were each defined. RESULTS: A total of 74 patients were enrolled. Of these, 45 (61%) (19 confirmed, 16 probable, and 10 possible) were classified as TBP. The other 29 (39%) patients were classified as not TB. The sensitivity and specificity, respectively, of the tested methods for diagnosing TBP were as follows: PBMC ELISPOT (≥6 spots), 84% and 59%; PF-MC ELISPOT (≥6 spots), 87% and 86%; PF-MC/PBMC ratio (≥3), 69% and 97%; and PF-ADA level (≥21 U/L), 82% and 79%. The areas under the ROC curves were as follows: PF-MC ELISPOT, 0.90; PF-MC/PBMC ratio, 0.82; PBMC ELISPOT, 0.80; and PF-ADA, 0.80, respectively. When a 2-step algorithm ('PBMC ELISPOT ≥6 spots or PF-ADA ≥21 U/L' as a rule-out test and 'PF-MC/PBMC ratio ≥3' as a rule-in test) was applied, 67% (30/45) of the patients with TBP were accurately classified without undergoing invasive procedures. CONCLUSIONS: A 2-step algorithm using the PBMC/PF-MC ELISPOT assays and PF-ADA appears to be a promising rapid and non-invasive approach for diagnosing TBP.
Authors: Ruixi Zhou; Xia Qiu; Junjie Ying; Yan Yue; Tiechao Ruan; Luting Yu; Qian Liu; Xuemei Sun; Shaopu Wang; Yi Qu; Xihong Li; Dezhi Mu Journal: Front Public Health Date: 2022-09-21