Diagnostic Accuracy of Serum Procalcitonin (PCT) as an Early Biomarker of Neonatal Sepsis using Blood Culture as Gold Standard.

OBJECTIVE: To ascertain the diagnostic accuracy of serum PCT as an early biomarker of neonatal sepsis using blood culture as gold standard, so that the condition could be diagnosed and managed early to prevent and reduce morbidity and mortality in neonates.  Study Design: Cross-sectional study. PLACE AND DURATION OF STUDY: Dr. Ziauddin University Hospital, Karachi, from March 2019 to December 2019. METHODOLOGY: A total of 171 neonates, 1-29 days of age, presented with clinical diagnosis of neonatal sepsis, were included in this study. Patients' data regarding age, gender, birth weight, prematurity and premature rupture of membranes (PROM) were collected. Blood cultures were performed in Microbiology Department; and Serum PCT was analyzed on Electrochemiluminescence Immunnoassay Analyzer (Cobas e601). Diagnostic accuracy, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of PCT were calculated with contingency tables using blood culture findings as gold standard. RESULTS: Out of 171 clinically diagnosed cases of neonatal sepsis, 86 (50.3%) were confirmed as having neonatal sepsis (blood culture positive). There was a significant difference in serum PCT levels in both the groups. The sensitivity of PCT was 97.7%; specificity 70.6%; PPV 77.1; NPV 96.8%; likelihood ratio of a positive test (LR+ve) 3.32; likelihood ratio of a negative test (LR -ve) 0.03, and cumulative diagnostic accuracy of PCT 84.2%. CONCLUSION: PCT is a very useful biomarker for the early diagnosis of neonatal sepsis, showing 84.2% diagnostic accuracy. Thus PCT can help in making early clinical decisions regarding management of patients. Key Words: Diagnostic accuracy, PCT, Neonatal sepsis.

Diagnostic Accuracy of Risk of Ovarian Malignancy Algorithm (ROMA) in Post-Menopausal Patients with Ovarian Mass.

OBJECTIVE: To determine the diagnostic accuracy of ROMA in postmenopausal women with history of ovarian mass. STUDY DESIGN: Observational study. PLACE AND DURATION OF STUDY: Dr. Ziauddin University Hospital, Karachi, from May 2014 to June 2015. METHODOLOGY: Two hundred and sixty postmenopausal women of 40-65 years of age with ovarian masses, planned for surgery, were included in the study. Their samples were obtained preoperatively and analysed on Abbot Architect i1000 SR immunoassay analyser for quantitative estimation of tumor markers, i.e. HE4 and CA125. By combination of these two tumor markers, ROMA scores were calculated and studied after histopathological verification of masses. RESULTS: Total number of patients were 260, out of which 122 (46.9%) were diagnosed as having ovarian cancer, while 138 (53.0%) were diagnosed as benign condition. Median ROMA score levels in patients with malignant masses were 95.58 (IQR=44.4) as compared to 20.6 (IQR=14) in benign masses. ROMA had sensitivity 92.6% (CI=86.47-96.04), specificity 78.3% (CI=70.09-83.82), positive predictive value 79% (CI=70.87-84.29), negative predictive value 92.3% (CI=86.02-95.9) and positive likelihood ratio 4.26, while negative likelihood ratio 0.1. Diagnostic accuracy of ROMA was 85%, based on ROC curve analysis. ROMA had the highest sensitivity in detecting ovarian carcinoma. CONCLUSION: ROMA is a very useful diagnostic tool for the preoperative stratification of patients with ovarian masses showing 85% diagnostic accuracy. However, there is need of more studies with homogenous laboratory procedures for HE4 and CA125 assays as well as patients, selection criteria, so we can draw firm conclusion about utility of ROMA in clinical setups.