In current clinical practice, Serum Creatinine (SCr) is a commonly used marker for the diagnosis of acute kidney injury (AKI). Unfortunately, due to a delayed increase in SCr, it is unable to accurately estimate the timing of the injury. The purpose of this study was to assess the ability of plasma neutrophil gelatinase-associated lipocalin (pNGAL) to predict AKI in critically ill adult patients . The study was conducted at the Section of Chemical Pathology, Department of Pathology& Laboratory Medicine in collaboration with Department of Anesthesiology, at Aga Khan University Hospital in Karachi, Pakistan. Subjects in the age groups of18 to 60, that were admitted into the intensive care unit (ICU) with suspected sepsis were enrolled in this study.AKI was labeled by using Risk-Injury-Failure-loss-End Stage (RIFLE) criteria. Forty-eight patients, mean age being 46.5 ± 16.3, were recruited over a nine-month period. Multiple blood samples were collected from each patient at 12 h, 24 h, and 48 h. A total of 52.1% ( n = 24) of ICU patients suspected of sepsis had developed AKI. Baseline characteristics of subjects with AKI were compared to those without AKI. Statistically significant difference was noted in gender ( p -value< 0.05) and pNGAL ( p -value< 0.001). However, no significant differences were seen with respect to age, in patients with and without AKI. The area under the curve (AUC) at12hr was 0.82 (95% CI 0.68–0.96) with a sensitivity of 70.8% and specificity of 90.9%.While AUCs at 24 h was 0.86(95% CI 0.74–0.97) with a sensitivity of 78.5% and specificity of 88.8%. Furthermore, there was a positive correlation between pNGAL and the length of ICU stay ( r = 0.98). Non-survivors or expired patients had higher median pNGAL170 (202–117) ng/ml as compared to survivors 123(170–91) ng/ml . In conclusion, pNGAL is an early predictor of AKI in a heterogeneous adult ICU population. Plasma NGAL allows the diagnosis of AKI 48 h prior to a clinical diagnosis based on RIFLE criteria. Early identification of high-risk AKI in patients may allow earlier initiation of therapies and improve patient outcome.
Background: Covid-19 spread through blood transfusion has not yet been reported. Despite the prevailing pandemic, there are no recommendations available as yet for testing SARS-CoV-2 antibodies as part of blood screening. Objective: To determine the seroprevalence of SAR-CoV-2 antibodies, its clinical significance and to identify if total antibodies(IgA, IgM, IgG) should be tested or just the specific IgG antibodies only. Method: Consecutive blood donors donated were screened for standard serological panel of HbsAg, Anti-HCV, Anti-HIV and Syphilis using Cobas-411 analyser and Malaria. All seronegative donors were then screened for COVID serology using the same instrument. These results were compared with the blood donors' seroprevalence checked in a cohort in the first week of June 2020. Pre-COVID-19 period (October 2019) blood donors' archived samples were also compared. Donors who were positive on ECLIA were then tested for specific antibodies (IgM or IgG) by ELISA. Results: A total of 380 healthy blood donors were included. All were males with the mean age being 30.6 ± 6.3 years. Ten pre-pandemic samples did not show COVID-19 antibodies, whereas out of 70 samples in the 3rd week of June, only 15 (21.4 %) were positive. However, in July out of the 300 blood donors, 113 (37.7 %) were found to be reactive. To reconfirm our findings, these 113 donors were then tested on ELISA for presence of IgG specifically. Out of these 128 samples, 81 were IgG positive, 23 were borderline positive and 24 were negative. Conclusion: Almost 40 % of blood donors are now seroconverted for COVID-19. This is a reflection of widespread seroprevalence in the adult male population.
Background: Many laboratories are reporting a numerical cutoff index value (COI) value for most anti-SARS-CoV-2 qualitative tests. These numerical values in patients’ report ultimately created great confusion in the public and physicians, therefore this study was designed to evaluate the correlation of electrochemiluminescence (ECLIA) based numerical COI values with quantitative ELISA of anti-SARS-CoV-2 antibody.Design and Methods: Two hundred and twenty-eight (228) recovered COVID-19 patients were included; their serum samples were analyzed by quantitative ELISA and ECLIA for anti-SARS-COV-2 antibodies.Results: One hundred and seventy-three (75.8%) patients tested positive by ECLIA and ELISA assay and thirty-seven (6.2%) were tested negative by both methods. A weak positive correlation (r=0.37) was found between numerical COI value of ECLIA with ELISA concentration, which was statistically significant with p<0.001. All values were dispersed on scatter plot and there was no significant linear relationship between ECLIA and ELISA assay.Conclusions: As both testing techniques are base upon the same immunological phenomena of detecting antibodies against nucleocapsid protein. We suggest that COI values are not meant to describe the immunity level of the individuals thus the physicians should not consider it as a quantitative value for antibody levels in COVID-19 patients.
The clinical and epidemiological use of SARS-CoV-2 antibody assays is under debate with urgent need to validate and verify the performance of SARS-CoV-2 serologic assays. We aim to assess the clinical and analytical performance of three commercial serological assays of SARS-CoV-2, comparing three anti-SARS-CoV-2-IgG ELISA and identifying the seroconversion and seroprevalence in our population. A cross sectional study conducted from April 2020 to July 2020 at National Institute of Blood disease and Bone Marrow Transplantation Karachi, Pakistan with sample size of 404, enrolled consecutively. Participants were categorized into four groups namely convalescent plasmadonors (CPDs n=239), health care professionals (HCPs n=44), healthy blood donors (HBDs n=70) and from community (n=51). We evaluated the performance of Elecsys anti-SARS-CoV-2 electrochemiluminescence (ECLIA) assay on Cobas-e411 by Roche, three qualitative anti-SARS-CoV-2-IgG enzyme linked imunosorbant assay (ELISA) by (Generic assays, Euroimmun & Omega diagnostics) ,one quantitative ELISA assay by AESKU Diagnostics and two immune chromatography(ICT) kits namely InstaTestTM by CORTEZ and TEST IT by TURKLAB. From total 404 subjects, 322 (83.5%) were males. Mean age was 36.79 plus minus 11.95 years. Among 239 in CPDs group, 202(84.5%) showed positive antibodies by ECLIA. The qualitative anti-SARS-CoV-2 IgG ELISA was positive in 174 (72.8%) and quantitative IgG in 180(75.3%) with mean titer of 56.7 plus minus 39.7 U/ml. Sensitivity and specificity of ECLIA were 97.44& 99%, ELISA by Generic assays were 67.85% and 89.9%; Euroimmun had 90.38% and 94.9%; Omega Diagnostics 96.4% and 95% and the AESKULISA 93.75% and 100% respectively. Seroconversion was found to be 53.8% and 77.77% within 7 -8 days and 12 to 14 days post onset of symptoms respectively. ICT had more specificity but less sensitivity. Seroprevalence was found to be 84.5%, 40.9% and 21.4% in CPDs, HCPs and HBDs respectively. The Roche ECLIA, qualitative ELISA by Omega Diagnostics & Euroimmun showed higher sensitivity as well as higher specificity. Quantitative ELISA has higher specificity and relatively high sensitivity. Significant numbers of COVID patients do not have detectable antibodies by all assays.
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