Development and validation of the HEALTH scoring system = A novel and non-invasive laboratory panel to differentiate intestinal tuberculosis from other gastrointestinal diseases [version 1; peer review: awaiting peer review]

Backgrounds Tuberculosis (TB) remains a significant health issue in Indonesia, ranking second globally in TB incidence in 2021. Diagnosing intestinal tuberculosis (ITB) is challenging due to its symptoms, which mimic other diseases, limited laboratory tests, and the need for invasive procedures like colonoscopy. This study aimed to develop a non-invasive laboratory panel for ITB using various biomarkers. Methods A cross-sectional study from November 2020 to December 2022 was carried out at Dr. Cipto Mangunkusumo National Central General Hospital. Laboratory parameters from 143 subjects were identified by Chi-square test and multiple regression analysis. The scoring system was developed based on the identified independent diagnostic parameters scored by regression coefficient β value and standard errors, with the cut-off value determined by the ROC curve. The sensitivity and specificity of the scoring system were determined using the ROC curve. Results Among 143 subjects, 22 were diagnosed with ITB and 121 Non-ITB (prevalence of 15.38%). This study was dominated by females (65.03%), with a ratio of 1.86: 1. The median age in this study was 41 years. The scoring system to differentiate ITB and Non-ITB consisted of 6 diagnostic parameters (referred to as the HEALTH scoring system) as follows: stool HBD-2 (1 and 0 points), ESR (1 and 0 points), blood ADA activity (1 and 0 points), Lymphocyte (0 and 1 point), stool TB PCR (2 and 0 points), and NLR (1 and 0 points). Subjects with scores ≥ 4 could be diagnosed as ITB. The sensitivity and specificity of the HEALTH scoring system were 68.18% and 95.04%, respectively. Conclusion This study developed and validated a laboratory panel called the HEALTH scoring system based on clinical biomarkers of stool HBD-2 level, ESR, blood ADA activity, lymphocytes, stool TB PCR, and NLR, which could be used to differentiate ITB from other gastrointestinal diseases.