Isolated distal deep vein thrombosis associated with adenomyosis: Case report and literature review.

While adenomyosis is commonly associated with a mild risk of thrombotic complications, the presence of additional thrombophilia factors can increase this risk, particularly in individuals with severe symptoms and elevated CA125 levels.

Performance evaluation of Hipee S2 point-of-care testing urine dipstick analyser: a cross-sectional study.

OBJECTIVE: With advances in mobile technology, smartphone-based point-of-care testing (POCT) urinalysis hold great potential for disease screening and health management for clinicians and individual users. The purpose of this study is to evaluate the analytical performance of Hipee S2 POCT urine dipstick analyser. DESIGN: A multicentre, hospital-based, cross-sectional study. SETTING: Analytical performance of the POCT analyser was conducted at a clinical laboratory, and method comparison was performed at three clinical laboratories in China. PARTICIPANTS: Urine samples were collected from 1603 outpatients and inpatients at three hospitals, and 5 health check-up population at one of the hospitals. OUTCOME MEASURES: All tests were performed by clinical laboratory technicians. Precision, drift, carry-over, interference and method comparison of Hipee S2 were evaluated. Diagnostic accuracy of semiquantitative albumin-to-creatinine ratio (ACR) for albuminuria was carried out using quantitative ACR as the standard. RESULTS: The precision for each parameter, assessed by control materials, was acceptable. No sample carry-over or drift was observed. Ascorbate solution with 1 g/L had an inhibitory effect for the haemoglobin test. Agreement for specific gravity (SG) varied between moderate to substantial (κ values 0.496-0.687), for pH was moderate (κ values 0.423-0.569) and for other parameters varied between substantial to excellent (κ values 0.669-0.991), on comparing the Hipee S2 with laboratory analysers. The semiquantitative microalbumin and creatinine were highly correlated with the quantitative results. The sensitivity of semiquantitative ACR to detect albuminuria was 87.2%-90.7%, specificity was 70.7%-78.4%, negative predictive value was 85.3%-87.9% and positive predictive value was 73.9%-83%. CONCLUSIONS: Hipee S2 POCT urine analyser showed acceptable analytical performance as a semiquantitative method. It serves as a convenient alternate device for clinicians and individual users for urinalysis and health management. In addition, the POCT semiquantitative ACR would be useful in screening for albuminuria.

Antiplatelet therapy for patients with COVID-19: Systematic review and meta-analysis of observational studies and randomized controlled trials.

Background: Hyperinflammation and coagulopathy are hallmarks of COVID-19 and synergistically contribute to illness progression. Antiplatelet agents have been proposed as candidate drugs for COVID-19 treatment on the basis of their antithrombotic and anti-inflammatory properties. A systematic review and meta-analysis that included early observational studies and recent randomized controlled trials (RCTs) was performed to summarize and compare evidence on this issue. Methods: PubMed, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched to identify studies published up to Nov 7, 2021, and the results of registered clinical trials were followed up to Mar 30, 2022. We included RCTs and observational studies assessing the effect of antiplatelet therapy in adult patients with COVID-19. Data on baseline patient characteristics, interventions, controls, and outcomes were extracted by two independent reviewers. The primary outcome was mortality. Data were pooled using a random-effects model. Results: Twenty-seven studies were included, of which 23 observational studies were pooled in a meta-analysis, and the remaining four RCTs (ACTIV-4B, RECOVERY, ACTIV-4a, and REMAP-CAP) were narratively synthesized. Based on 23 observational studies of 87,824 COVID-19 patients, antiplatelet treatment favors a lower risk of mortality [odds ratio (OR) 0.72, 95% confidence interval (CI) 0.61-0.85; I 2 = 87.0%, P < 0.01]. The narrative synthesis of RCTs showed conflicting evidence, which did not support adding antiplatelet therapy to the standard care, regardless of the baseline illness severity and concomitant anticoagulation intensity. Conclusion: While the rationale for using antiplatelet treatment in COVID-19 patients is compelling and was supported by the combined result of early observational studies, evidence from RCTs did not confirm this approach. Several factors that could explain this inconsistency were highlighted alongside perspectives on future research directions.

Accuracy and Reliability of Whole Blood Bilirubin Measurements Using a Roche Blood Gas Analyzer for Neonatal Hyperbilirubinemia Screening and Risk Stratification.

Background: Accurate bilirubin measurements are essential for appropriate management of neonatal hyperbilirubinemia. This study aimed to evaluate the accuracy and reliability of whole blood bilirubin measurements obtained using a Roche blood gas analyzer (Roche TBiL), with total serum bilirubin (TSB) measurements determined by the Ortho VITROS 4600 chemistry system (Ortho TSB) serving as a reference. Materials and Methods: Medical records of hospitalized neonates that underwent simultaneous Roche TBiL and Ortho TSB measurements were reviewed for eligibility selection and data collection. The correlations and differences between two sets of results were determined using Passing-Bablok regression analysis and a Bland-Altman plot, respectively. For eligible newborns, the risk of developing severe hyperbilirubinemia was assessed using the Bhutani nomogram. Weighted kappa analysis was used to evaluate the agreement between risk prediction by the two methods. Results: We obtained 618 paired Roche TBiL and Ortho TSB results from 309 neonates. Roche TBiL and Ortho TSB measurements showed a good correlation (r = 0.923; 95% CI: 0.905-0.938). Passing-Bablok regression analysis yielded the following equation: Roche TBiL = 0.794 × Ortho TSB + 1.255 mg/dL, with a slope of 0.794 (95% CI: 0.763-0.825) and intercept of 1.255 (95% CI: 1.042-1.417). The average difference between the two methods was 0.1 ± 1.448 mg/dL. A total of 207 neonates were eligible for evaluation of the agreement between the risk-grading methods. Although kappa analysis showed good agreement between the methods, with a weighted kappa of 0.681 (95% CI: 0.610-0.751) across all populations, the values for approximately half of the neonates at intermediate and high risk of hyperbilirubinemia (33/72) were underestimated by Roche TBiL. Conclusion: Our results indicate that Roche TBiL and Ortho TSB measurements in the neonatal population are not consistent. As a point-of-care and trace blood assay, Roche blood gas bilirubin measurements can facilitate primary screening of neonatal hyperbilirubinemia, but it seems to lack accuracy regarding risk stratification, particularly for high-risk newborn individuals.

Performance Evaluation of Four Commercial Point-of-Care Testing Urine Analyzers for Diagnosing Urinary Tract Infection.

BACKGROUND: Urinalysis is used as a screening tool in case of a clinical suspicion of urinary tract infection (UTI). The purpose of this study is to evaluate the analytical performance, agreement, and screening value of four commercial point-of-care testing (POCT) urine analyzers for UTI. METHODS: The following four POCT analyzers were evaluated: Clinitek Status+, BW-200, Hipee S2, and URS-14K. The agreement of the four analyzers with the laboratory standard was assessed. The diagnostic indicators of the screening tests performed using POCT analyzers for UTI were calculated against the bacterial culture as the gold standard. RESULTS: Overall agreement of the four analyzers was good. For nitrite and leukocytes, all the analyzers showed substantial or excellent agreement with the laboratory reference standard, whereas agreement for erythrocytes varied from moderate to excellent. With each POCT analyzer, combined detection of nitrite, leukocytes, and erythrocytes provided better diagnostic performance than individual detection. Combined detection had higher sensitivity and negative predictive value, while the specificity and positive predictive value were higher for single detection of nitrite. CONCLUSIONS: Present findings demonstrate that the overall performance of the four POCT urine analyzers was sufficient for routine use for screening UTI. A result positive for nitrite is helpful for early diagnosis of UTI, and a result negative for the combination of nitrite, leukocytes, and erythrocytes is helpful for early elimination of UTI.

Analytical performance validation and clinical application of blood gas analyzer on the detection of neonatal bilirubin.

BACKGROUND: It is not yet clear whether the trace blood gas analyzer can be used for biochemical detection of newborns. This study aimed to evaluate the reliability of the method for the detection of bilirubin in infants. METHODS: Based on the Clinical and Laboratory Standards Institute (CLSI) EP15-A2 document, the analytical performance of the blood gas analyzer method for bilirubin detection in neonates was validated. The resulting data of 363 simultaneous bilirubin detection with blood gas analyzer (optical method) and biochemical analyzer (enzymatic method) were reviewed. According to the CLSI EP9-A3 document, the relevance and consistency of the measurement results were evaluated by Pearson correlation analysis, Passing-Bablok regression, and Bland-Altman deviation analysis. RESULTS: The precision and accuracy of the Werfen GEM 4000 blood gas analyzer for the detection of different levels of bilirubin samples adhered to the manufacturer's statement and industry quality standards. The bilirubin detection values of the 2 methods showed a good correlation, and both of them were significantly correlated (P<0.001). Passing-Bablok regression results showed that the regression equation of the bilirubin detection value of the 2 methods is y = -21.00 + 1.17x, with the slope as 1.17 [95% confidence interval (CI): 1.15 to 1.19], and the intercept was -21.00 (95% CI: -23.62 to -18.71), the data of the 2 sets were not consistent in each concentration range. The Bland-Altman plot demonstrated that the bilirubin detection value of 16/363 cases (4.4%) for the 2 methods exceeded the 95% limits of agreement (95% LoA); of which the maximum bias was -30.34 (95% CI: -38.48 to -22.26) and there were 5/76 cases (6.6%) outside the 95% LoA in the >300 µmol/L group. CONCLUSIONS: The method for detecting neonatal total bilirubin by trace blood gas analyzer basically meets the clinical requirements and can be used for the preliminary screening of neonatal jaundice. However, for severe hyperbilirubinemia that requires close monitoring of dynamics, a precise enzymatic quantification is required.

Thrombocytopenia Is Associated with COVID-19 Severity and Outcome: An Updated Meta-Analysis of 5637 Patients with Multiple Outcomes.

The COVID-19 pandemic is persistent worldwide. A prior meta-analysis suggested the association of thrombocytopenia (TCP) with more severe COVID-19 illness and high mortality. Considering newly published studies, we updated the previous meta-analysis to confirm and explain the association of TCP with COVID-19 severity and multiple outcomes. Twenty-four studies with 5637 patients with COVID-19 were included in this study. The weighted incidence of TCP in COVID-19 was 12.4% (95% confidence interval [CI], 7.9%-17.7%). Data synthesis showed that the platelet number was lower in patients with either more severe illness or poor outcomes and even lower in nonsurvivors, with weighted mean differences of -24.56 × 109/L, -22.48 × 109/L, and -49.02 × 109/L, respectively. The meta-analysis of binary outcomes (with and without TCP) indicated the association between TCP and 3-fold enhanced risk of a composite outcome of intensive care unit admission, progression to acute respiratory distress syndrome, and mortality (odds ratio [OR], 3.49; 95% CI, 1.57-7.78). Subgroup analysis by endpoint events suggested TCP to be significantly associated with mortality (OR, 7.37; 95% CI, 2.08-26.14). Overall, the present comprehensive meta-analysis indicated that approximately 12% of hospitalized patients with COVID-19 have TCP, which also represents a sign of more severe illness and poor outcomes.

Performance Evaluation of Different Commercial Serological Kits for Diagnosis of Acute Hepatitis E Viral Infection.

Clinical diagnosis of hepatitis E viral (HEV) infection mainly relies on serological assays, and the current status of misdiagnoses regarding HEV infection is uncertain. In this study, patients with acute HEV infection were tested for anti-HEV IgM and IgG, a HEV antigen (Ag), and viral loads (HEV RNA). Serology was performed using four commercial HEV ELISA kits: Wantai, Kehua, Lizhu, and Genelabs IgM and IgG. The HEV RNA was detected using RT-PCR assays. The sensitivities of different kits for anti-HEV IgM ranged from 82.6% to 86%. Each kit for anti-HEV IgM was highly specific (97.8-100%). The sensitivities of all kits to detect anti-HEV IgG with (87.2-91.9%) had a substantial agreement, but the Kehua and Genelabs tests were more specific than the Wantai and Lizhu tests. The Wantai tests for the HEV Ag and HEV RNA were also important for acute HEV infections (Kappa = 0.787). Furthermore, a total of 6.98% of HEV infections were positive for HEV RNA but negative for both the HEV Ag and anti-HEV antibodies of IgM and IgG classes. Our findings demonstrate that the diagnosis of hepatitis E may be missed if only serological assays are used. Thus, a combination of serological and nucleic acid testing provides the optimal sensitivity and specificity to the diagnostic process.Clinical diagnosis of hepatitis E viral (HEV) infection mainly relies on serological assays, and the current status of misdiagnoses regarding HEV infection is uncertain. In this study, patients with acute HEV infection were tested for anti-HEV IgM and IgG, a HEV antigen (Ag), and viral loads (HEV RNA). Serology was performed using four commercial HEV ELISA kits: Wantai, Kehua, Lizhu, and Genelabs IgM and IgG. The HEV RNA was detected using RT-PCR assays. The sensitivities of different kits for anti-HEV IgM ranged from 82.6% to 86%. Each kit for anti-HEV IgM was highly specific (97.8­100%). The sensitivities of all kits to detect anti-HEV IgG with (87.2­91.9%) had a substantial agreement, but the Kehua and Genelabs tests were more specific than the Wantai and Lizhu tests. The Wantai tests for the HEV Ag and HEV RNA were also important for acute HEV infections (Kappa = 0.787). Furthermore, a total of 6.98% of HEV infections were positive for HEV RNA but negative for both the HEV Ag and anti-HEV antibodies of IgM and IgG classes. Our findings demonstrate that the diagnosis of hepatitis E may be missed if only serological assays are used. Thus, a combination of serological and nucleic acid testing provides the optimal sensitivity and specificity to the diagnostic process.