Trimester-specific reference intervals and profile of coagulation parameters for Chinese pregnant women with diverse demographics and obstetric history: a cross-sectional study.

BACKGROUND: Owing to the changes in childbirth policy in China, this work aimed to update the trimester-specific reference intervals (RIs) for Chinese pregnant women with diverse demographics and obstetric history. This study also investigated how advanced maternal age (AMA) (> 35 years old), gravity, and parity influence gestational coagulation parameters. METHODS: In this prospective cross-sectional study, five coagulation parameters were measured using assays provided by Roche diagnostics on Cobas t 711: prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT), fibrinogen (Fib), and D-dimer, and the trimester-specific 2.5th -97.5th and 95th (D-dimer only) percentiles RIs were established accordingly. Linear regressions were undertaken to analyze the association with demographic characteristics and obstetric history for each parameter. RESULTS: 893 eligible pregnant women in different trimesters and at AMA/non-AMA and 275 non-pregnant healthy women were enrolled. For the first, second, and third trimester, respectively, RIs were as follows: APTT (s): 24.8-35.7, 24.6-34.1, and 23.5-34.7; TT (s): 14.4-17.3, 14.1-16.7, and 14.2-17.5; PT (s): 8.30-10.20, 8.00-9.77, and 7.92-9.57; PT-INR: 0.86-1.06, 0.83-1.02, and 0.82-0.98; Fib (g/L): 2.76-4.97, 3.14-5.31, and 3.44-5.93; D-dimer (µg/ml): 0-0.969, 0-2.14, and 0-3.28. No statistically significant differences were observed in TT, D-dimer, and APTT between the AMA and non-AMA women, while PT and PT-INR were shorter and Fib was higher in the AMA group. The association of gravidity and parity with each coagulation parameter is statistically significant (p < 0.05). PT and PT-INR were shortened and D-dimer decreased as gravidity increased. Longer PT and PT-INR, shorter APPT, higher D-Dimer, and lower Fib were associated with increasing parity. CONCLUSIONS: This work updated the gestational coagulation profiles of Chinese pregnant women and established trimester-specific RIs accordingly. Establishing specific RIs based on AMA, parity, and gravidity might not be necessary.

Performance of the ABC-bleeding risk score for assessing major bleeding risk in Chinese patients with atrial fibrillation on oral anticoagulation therapy: A real-world study.

Objective: To evaluate performance of the ABC (Age, Biomarkers, Clinical history)-bleeding risk score in estimating major bleeding risk in Chinese patients with atrial fibrillation (AF) on oral anticoagulation (OAC) therapy in real-world practice. Methods: Data were collected from the Chinese Atrial Fibrillation Registry study (CAFR). Patients were stratified into low-, medium-, and high-risk groups based on ABC-bleeding risk score with 1-year major bleeding risk (<1%, 1-2%, and > 2%) and modified HAS-BLED score (≤1, 2, and > 2 points). Cox proportional-hazards (Cox-PH) models were used to determine the association of major bleeding incidence with bleeding scores. Harrell's C-index of the two scores were compared. Net reclassification improvement (NRI) and integrated discrimination improvement (IDI) at 1 year were employed to evaluate the reclassification capacity. The calibration curve was plotted to compare the predicted major bleeding risk using ABC-bleeding risk score with the observed annualized event rate. The decision analysis curves (DCA) were performed to show the clinical utilization of two scores in identifying major bleeding events. Results: The study included 2,892 AF patients on OAC therapy. After the follow-up of 3.0 years, 48 patients had major bleeding events; the incidence of a bleeding event in the low-, medium-, and high-risk groups according to ABC-bleeding risk score was 0.31% (reference group, HR = 1.00),0.51% (HR = 1.83, 95%CI: 0.91-3.69, P = 0.09), and 1.49% (HR = 4.92, 95%CI: 2.34-10.30, P < 0.001), respectively. Major bleeding incidence had an independent association with growth differentiation factor 15 (GDF-15) level (HR = 2.16, 95%CI: 1.27-3.68, P = 0.005) after adjusting components of the HAS-BLED score and cTnT-hs level. The ABC-bleeding score showed a Harrell's C-index of 0.67 (95%CI: 0.60-0.75) in estimating major bleeding risk, which was non-significant compared to the modified HAS-BLED score (0.67 vs. 0.63; P = 0.38). NRI and IDI also revealed comparable reclassification capacity of ABC-bleeding risk score compared with HAS-BLED score (14.6%, 95%CI: -10.2%, 39.4%, P = 0.25; 0.2%, 95%CI -0.1 to 0.9%, P = 0.64). Cross-tabulation of the two scores showed that the ABC-bleeding score outperformed the HAS-BLED score in identifying patients with a high risk of major bleeding. The calibration curve showed that the ABC-bleeding risk score overestimated the observed major bleeding risk. DCA did not show any difference in net benefit when using either of the scores. Conclusion: This study verified the value of the ABC-bleeding risk score in assessing major bleeding risk in Chinese patients with AF on OAC therapy in real-world practice. Despite the overestimation of major bleeding risk, ABC-bleeding score performed better in stratifying patients with a high risk than the modified HAS-BLED score. Combining the two scores could be a clinically practical strategy for precisely stratifying AF patients, especially those at a high risk of major bleeding, and further supporting the optimization of OAC treatment.

A study of performance evaluation of cobas e 801 infectious diseases panel.

BACKGROUND: Infectious diseases, such as HCV infection, HBV infection and syphilis, put a huge burden on public health. Accurate and fast testing is required for clinical usage. OBJECTIVES: This study aimed to evaluate the clinical performance of Elecsys® Anti-HCV II, Elecsys® HBsAg II and Elecsys® Syphilis using samples from routine diagnosis in China. METHODS: Specificity was tested in approximately 3000 unselected pseudonymized samples from routine clinical patients for each assay. Sensitivity of HCV and HBsAg assays was tested in 2 seroconversion panels, respectively. RESULTS: The 3 investigational assays on cobas e 801 were showed to have excellent sensitivity and specificity which is comparable to existing assays. CONCLUSION: They are suitable for routine clinical diagnostic use, including pre-operative assessment in China.

Performance evaluation of Elecsys HIV Duo on cobas e 801 using clinical samples in China.

The prevalence and incidence of human immunodeficiency viruses (HIV) infection are rapidly increasing, and novel HIV genotypes are emerging. This study evaluated the sensitivity and specificity of Elecsys HIV Duo assay in population with the epidemic of multiple genotypes of HIV-1 infection. Specificity of the Elecsys HIV Duo assay was determined using 3039 serum samples from patients receiving routine HIV-1 screening tests in China. Sensitivity was assessed with seroconversion panels. Additional 67 positive from newly diagnosed HIV-1 infected samples were also included to test assay performance on various HIV-1 genotypes. The assay performance was compared with that of the Elecsys HIV Combi PT assay. The genotypes of all HIV-1 positive samples were determined with phylogenetic analyses on the 1.1 kb Pro-RT region of pol gene for drug resistance tests. The Elecsys HIV Duo assay had a slightly higher specificity (99.93% vs 99.84%) and equivalent sensitivity to Elecsys HIV Combi PT assay. Seventy-two HIV-1 positive samples, including 12 antigens positive samples, were distinguished by Elecsys HIV Duo. Among them, 43 samples were circulating recombinant form (CRF)01_AE, followed by 13 of CRF07_BC, 10 of subtype B, 4 of URF_0107, 1 of URF_01B and 1 of CRF02_AG. The Elecsys HIV Duo assay showed good performance for the Chinese population with an epidemic of multiple HIV genotypes.

Tendency for age-specific mortality with hypertension in the European Union from 1980 to 2011.

Tendency for mortality in hypertension has not been well-characterized in European Union (EU). Mortality data from 1980 to 2011 in EU were used to calculate age-standardized mortality rate (ASMR, per 100,000), annual percentage change (APC) and average annual percentage change (AAPC). The Joinpoint Regression Program was used to compare the changes in tendency. Mortality rates in the most recent year studied vary between different countries, with the highest rates observed in Slovakia men and Estonia women. A downward trend in ASMR was demonstrated over all age groups. Robust decreases in ASMR were observed for both men (1991-1994, APC = -13.54) and women (1996-1999, APC = -14.80) aged 55-65 years. The tendency of systolic blood pressure (SBP) from 1980 to 2009 was consistent with ASMR, and the largest decrease was observed among Belgium men and France women. In conclusion, SBP associated ASMR decreased significantly on an annual basis from 1980 to 2009 while a slight increase was observed after 2009. Discrepancies in ASMR from one country to another in EU are significant during last three decades. With a better understanding of the tendency of the prevalence of hypertension and its mortality, efforts will be made to improve awareness and help strict control of hypertension.