SERIAL CRP EVALUATION FOR THE DIAGNOSIS OF NEONATAL SEPSIS: A PROSPECTIVE OBSERVATIONAL STUDY.

Aim: to evaluate the role of serial CRP evaluation in the diagnosis of neonatal sepsis. Materials and Methods: The present prospective observational study was conducted in the Department of Pediatrics, Darbhanga Medical College and Hospital, Bihar for the period of 1 year. A total of 97 neonates suspected of sepsis having birth-weight >1,500 g constituted the study population. CRP was measured from the serum by quantitative turbidimetric immunoassay. The CRP 1 level was measured at the time of clinical presentation; CRP 2 and CRP 3 were measured at 24 and 48 hours respectively. Results: In the present study out of total 97 subjects, there were 59 (60.8%) males and 38 (39.2%) females. CRP was found positive in 60 cases. In the present study, lethargy (100%), decreased activity (100%), poor feeding (94.7%), poor cry (94.7%), tachypnea (89.5%), hypotonia (47.4%), hypothermia (31.6%), convulsion (26.5%), prolonged CFT (21.1%) and fever (10.5%) were the various symptoms observed. Conclusion: Serial CRP measurements are useful in the diagnosis of neonatal sepsis. CRP 3 level may virtually rule out or rule in the diagnosis of neonatal sepsis, and has very good correlation with blood culture. Keywords: CRP, Sepsis, Neonates

Latex Agglutination Turbidimetric Immunoassay Versus Enzyme-Linked Immunosorbent Assay for Helicobacter pylori: An Observational Study.

Background: Helicobacter pylori antibody levels in the blood are currently measured using an enzyme-linked immunosorbent assay (ELISA). In April 2016, FUJIFILM Wako Pure Chemical Corporation launched the “L-type Wako Helicobacter pylori antibody J” test, which is based on the latex agglutination turbidimetric immunoassay. In this study, we investigated the usefulness of the Wako test. Methods: We measured H. pylori antibody levels using both ELISA and Wako tests in 180 patients who underwent esophagogastroduodenoscopy at our hospital between September 2017 and February 2019. Ninety patients had H. pylori infections. We calculated the diagnostic accuracy, sensitivity, and specificity of each test and the concordance rate between the two tests. If the lower limits of 90% confidence intervals (CI) for each diagnostic validity exceeded the 85% threshold, the usefulness of the diagnostic test was confirmed. Results: Diagnostic accuracy, sensitivity, and specificity were 94.4% (90% CI; 90.8–97.0%), 94.4% (90% CI; 88.7–97.8%), and 94.4% (90% CI; 88.7–97.8%), respectively, using the Wako test, and 94.4% (90% CI; 90.8–97.0%), 88.9% (90% CI; 81.9–93.8%), and 100% (90% CI; 96.0–100%), respectively, using ELISA. The concordance rate between the two tests was high (κ = 0.8444). Conclusions: We confirmed the usefulness of the Wako test, especially when screening for H. pylori infection, due to its high sensitivity.Trial registration: We retrospectively registered the data of this study.

AB1236 KL-6 AS A BIOMARKER FOR SJÖGREN SYNDROME-ASSOCIATED INTERSTITIAL LUNG DISEASE: METHODOLOGY MATTERS

Background:Krebs von den Lungen-6 (KL-6) was recently found to be a serum biomarker for various disease associated interstitial lung disease (ILD) including primary Sjögren syndrome (pSS).1KL-6 is a high-molecular-weight glycoprotein in the Mucin 1 protein group and is majorly expressed by regenerating type II pneumocytes; hence, serum KL-6 levels may reflect the severity of pulmonary damage with regeneration.2Human KL-6 also promotes the proliferation and survival of pulmonary fibroblasts and the differentiation of myofibroblasts, which enhance fibrosis.3, 4Objectives:To evaluate the agreement between the latex particle-enhanced turbidimetric immunoassay with enzyme-linked immunosorbent assay (ELISA) and association with clinical phenotypes.Methods:This retrospective case-control study included 39 patients with pSS, of whom 21 (53.85%) patients developed ILD at the end of follow-up. The serum KL-6 level was compared between latex particle-enhanced turbidimetric immunoassay (Nanopia) and ELISA (MBS2601395; MyBioSource, CA, USA). Electronic medical records were reviewed, including clinical information, images, pulmonary function test, and laboratory results on inclusion, and a chest physician reviewed the results of pulmonary radiography.Results:The two serum KL-6 immunoassays revealed a moderate correlation with a Pearson product-moment correlation coefficient of 0.427. Serum KL-6 levels, measured using ELISA, were 1920.10 ± 1974.26 U/mL and 894.11 ± 788.53 U/mL in the ILD and non-ILD groups, respectively (p = 0.001). The latex particle-enhanced turbidimetric immunoassay for serum KL-6 was 459.62 ± 331.41 U/mL and 265.33 ± 105.37 U/mL in the ILD and non-ILD group, respectively (p = 0.074). The predictive values of serum KL-6 in the area under the receiver-operating characteristic curve were 0.810 and 0.669 in ELISA and latex particle-enhanced turbidimetric immunoassay, respectively.Conclusion:Serum KL-6 is a predicting biomarker in pSS patients who may develop ILD. However, the methodology of immunoassay may influence the efficacy of the prediction and clinical association.References:[1]Chiu Y-H, Lu C-C, Liu F-C, et al. FRI0228 KL-6 AS A BIOMARKER OF DEVELOPING INTERSTITIAL LUNG DISEASE IN PATIENTS WITH SJÖGREN SYNDROME.Ann Rheum Dis. 2019; 78: 793.[2]Yousefi M, Dehghani S, Nosrati R, et al. Aptasensors as a new sensing technology developed for the detection of MUC1 mucin: A review.Biosensors & bioelectronics. 2019; 130: 1-19.[3]Xu L, Yan DR, Zhu SL, et al. KL-6 regulated the expression of HGF, collagen and myofibroblast differentiation.Eur Rev Med Pharmacol Sci. 2013; 17: 3073-7.[4]Ohshimo S, Yokoyama A, Hattori N, Ishikawa N, Hirasawa Y and Kohno N. KL-6, a human MUC1 mucin, promotes proliferation and survival of lung fibroblasts.Biochem Biophys Res Commun. 2005; 338: 1845-52.Acknowledgments:This work was supported by National Defense Medical Center and Tri-Service General Hospital (TSGH-D-109183). The authors thank Kuo’s Yuan In Enterprise co., LTD for supporting Nanopia KL-6 Kit.Disclosure of Interests:None declared

Evaluation of a novel latex enhanced turbidimetric immunoassay for detecting autoantibody against extractable nuclear antigens

Detection of autoantibody against extractable nuclear antigens (ENAs) plays a critical role in the diagnosis and management of autoimmune diseases.In this study, we assessed the performance of LETIA in detecting anti-ENAs. Total 606 serum samples from the Second Hospital of Shanxi Medical University were collected. Anti-SSA, anti-SSB, anti-Sm, anti-U1-snRNP, and anti-Sm/RNP were parallelly detected by LETIA and line immunoblot (LIA). Besides, this study assessed LETIA for its repeatability in detecting anti-ENAs autoantibodies, and consistency with LIA. A receiver operating characteristic (ROC) curves was drawn to assess the accuracy of LETIA. The LETIA and LIA showed high coincidence rate in detecting anti-SSA, anti-SSB, anti-Sm, anti-U1-snRNP, and anti-Sm/RNP autoantibodies, with the results being 87.22%, 96.61%, 97.03%, 88.28%, and 92.06%, respectively. Almost perfect consistency (kappa > 0.8) were found in the detection of anti-SSB and anti-Sm by LETIA and LIA. While in the detection of anti-SSA, anti-U1-snRNP, and anti-Sm/RNP, moderate consistency (0.6 ⩽ kappa ⩽ 0.8) were shown. The AUCs of anti-SSA, anti-SSB, anti-Sm, anti-U1-snRNP, and anti-Sm/RNP detected by LETIA were 0.972 (95% confidence interval (CI): 0.941–1.000, p < 0.001), 0.986 (95% CI: 0.967–1.000, p < 0.001), 0.912 (95% CI: 0.763–1.000, p < 0.001), 0.829 (95% CI: 0.731–0.928, p < 0.001), and 0.828 (95% CI: 0.715–0.941, p < 0.001), respectively. LETIA and LIA showed considerable consistency in detecting anti-ENAs. Moreover, with the pronounced advantages of automatic and rapid detection, and high universality, LETIA can meet the requirements for quantitative detection of anti-ENAs.