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Objective:To compare the practical value of three statistical methods in establishing reference intervals by the indirect method.Methods:This is a methodological evaluation study. The data of coagulation parameters were obtained from laboratory information system, which were from pregnant women who had done prenatal examination in Peking University First Hospital from January 2017 to December 2019. The test results from 32 401 pregnant women were collected. Those healthy pregnant women were divided into three groups: early pregnancy group(n=11 151), middle pregnancy group(n=4 872) and late pregnancy group(n=16 378). Statistical analysis was performed for the result of PT, APTT, FIB, TT, D-D and FDP, and the necessity of stratification based on age in different periods of pregnancy was analyzed. Stratification based on age was necessary in three pregnancy groups for PT and APTT, in late pregnancy group for FIB and TT, and in early pregnancy group for D-D. The reference intervals of coagulation parameters were calculated by three statistical methods: non-parametric method, Hoffmann method and Q-Q plot method. Forty-two healthy pregnant women from October 2019 to January 2020 were enrolled as reference individuals for the validation of the reference intervals.The proportions of test results outside the reference intervals in the reference population calculated and compared.Results:The levels of the six coagulation assays vary significantly during the three periods of pregnancy, stratification based on age was necessary in three pregnancy groups for PT and APTT, in late pregnancy group for FIB and TT, and in early pregnancy group for D-D. If the number of test results was large, non-parametric and Hoffmann method provided more similar results, while the reference intervals calculated with Q-Q plot method was slightly wider than Hoffmann method. If the number of test results was small, reference intervals calculated with Hoffmann and Q-Q plot method were more reliable. For pregnant women during early pregnancy under the age of 35, the reference intervals of PT, APTT, FIB and TT calculated by this method were (10.44-13.11)s, (25.29-35.88)s, (2.61-4.64)g/L and (11.53-15.58)s.Conclusion:When establishing the reference interval, stratification according to pregnancy period and age was needed. Hoffmann method can be used as an alternative to the direct method.
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Objective To evaluate the diagnostic value of the Eating Assessment Tool (EAT-10) in screening dysphagia by using 2 and 3 as cut-off value with systematic review. Methods A retrieval on the diagnostic value of EAT-10 in dysphagia was done all through PubMed, Embase, the Cochrane Library, CBM, CNKI, WANFANG and VIP databases (from January 2008 to November 2016)."Quality As-sessment of Diagnostic Accuracy Studies" (QUADAS) was used to appraise included papers. Meta-Disc1.4 software was used to analyze heterogeneity and the combined effect of the data. Results Three papers were included and 394 subjects were included in the review. By using 2 and 3 as the cut-off value of EAT-10, the value of the weighted sensitivity was 0.84 [95%CI (0.79, 0.88)] and 0.77 [95%CI(0.71, 0.82)], the specificity was 0.64[95%CI (0.55, 0.72)] and 0.74 [95%CI(0.66, 0.81)],and the area under the receiver-operating-characteris-tic-curve (AUC-ROC) was 0.8621 and 0.8343, which illustrated the diagnostic accuracy of EAT-10 on dysphagia at the medium level. Conclusion The diagnostic ability of EAT-10 is good, but the sensitivity and specificity are different by using 2 and 3 as the cut-off value. The subjects should consider the specific clinical situation to determine the best cut-off value.
ABSTRACT
Objective To evaluate the diagnostic value of the Eating Assessment Tool (EAT-10) in screening dysphagia by using 2 and 3 as cut-off value with systematic review. Methods A retrieval on the diagnostic value of EAT-10 in dysphagia was done all through PubMed, Embase, the Cochrane Library, CBM, CNKI, WANFANG and VIP databases (from January 2008 to November 2016)."Quality As-sessment of Diagnostic Accuracy Studies" (QUADAS) was used to appraise included papers. Meta-Disc1.4 software was used to analyze heterogeneity and the combined effect of the data. Results Three papers were included and 394 subjects were included in the review. By using 2 and 3 as the cut-off value of EAT-10, the value of the weighted sensitivity was 0.84 [95%CI (0.79, 0.88)] and 0.77 [95%CI(0.71, 0.82)], the specificity was 0.64[95%CI (0.55, 0.72)] and 0.74 [95%CI(0.66, 0.81)],and the area under the receiver-operating-characteris-tic-curve (AUC-ROC) was 0.8621 and 0.8343, which illustrated the diagnostic accuracy of EAT-10 on dysphagia at the medium level. Conclusion The diagnostic ability of EAT-10 is good, but the sensitivity and specificity are different by using 2 and 3 as the cut-off value. The subjects should consider the specific clinical situation to determine the best cut-off value.
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Objective Women with gestational diabetes mellitus (GDM) are at risk to develop Type 2 diabetes mellitus ( DM2).The aim of this study is to compare the effect of three diagnostic criteria on the prevalence of GDM.Methods 2864 pregnant women receiving obstetric care at 24 to 28 weeks of gestation at Peking University First Hospital,underwent the 75 g oral glucose tolerance test for routine GDM screening.The pregnancies were evaluated bythe American Diabetes Association (ADA 2004) Cuideline,the new criteria which was proposed by the International Association of Diabetes and Pregnancy Study Groups (IADPSG 2010) based on the HAPO study,not by the criteria of American College of Obstetricians and Chinese Obstetrics and Gynecology (6th edition 2005).Venous plasma glucose was measured by the IDMS-traceable glucose oxidase method.Results The mean age of the women was 30 years.590 women were diagnosed with GDM using the IADPSG criteria.According to the IADPSG standard,GDM diagnostic rate reached 20.6％.The diagnostic rate of new criteria was increased by 307％ and 199％ compared with the Chinese Obstetrics and Gynaecology (6th edition) and the old ADA standard,respectively.If increasing the number of abnormal glucose values in the IADPS standard to 2 or more,the number of positive cases dropped to 227 people.The diagnostic rate of GDM plummeted to 7.93％,similar with that of the old ADA diagnostic criteria (6.8％).Conclusions The diagnosis rate of GDM was significantly higher using the IADPSG criteria,due to more stringent glucose abnormality recommended by the IADPSG.
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Objective To construct a prokaryotic expression system for human creatine kinase(CK) MM isozyme,purify the recombinant protein of CK expressed in Eschericheia coli(E.coli) and examine the stability of the recombinant protein for its application in CK measurement system as the quality control.Methods Total RNA of extracted from fetal cardiac muscle was reversetranscripted and cDNA encoding human CK was amplified which was inserted into pET-15b plasmid vector.The recombinant plasmid was transfered into E.coli BL21(DE3) and induced by isopropyl-?-D-thiogalactopyranoside(IPTG).Recombinant CK-MM was separated from bacterial proteins by affinity chromatography on a Ni2+-Sepharose column.The activity of the recombinant enzyme was observed in different matrixes.Results The enzymatic activity of the crude extracts of CK-MM was up to 280,000U/L.After one step affinity chromatography,the fusion protein showed a single band in SDS-PAGE gel.The purified protein was stable and the enzymatic activity remained unchanged for a month in the matrix containing bovine serum albumin,EDTA and 1,4-Dithiothreitol(DTT).Conclusion The recombinant CK-MM showed key properties of the native creatine kinase isozyme and may be used as control and calibrator for determination of serum CK-MM.