国产和进口HIV酶联免疫试剂盒精确性检测比较

目的通过检测东莞市中心血站购进的进口及国产HIV抗体酶联免疫试剂盒的精确性,以评价其质量及实用性。方法对所购进口、国产试剂盒每批次进行随机抽样,采用国家标准品的考核血清盘共47个样本进行检测,计算每批次的特异性、灵敏度、精密度等指标,计算其批间变异系数并进行比较分析。结果进口抗-HIV诊断试剂盒有3个批号的特异性为95％,7个为100％;国产抗-HIV诊断试剂盒,2个批号的特异性为95％,8个为100％;灵敏度全部为100％,两者比较没有统计学差异。采用10批次的进口和国产试剂盒平行检测47个血清盘标准样本,比较其吸光度值的变异系数,有统计学差异。结论第四代进口抗-HIV诊断试剂盒与国产比较,都符合国家有关规定,第四代进口试剂检测灵敏度和特异性并没有明显优势,但其总体稳定性优于国产试剂。     

Pregnancy-associated plasma protein A in non-cardiac conditions

ObjectivePAPP-A is a promising new marker in coronary heart disease. It is important to investigate its specificity in order to establish its clinical utility as a marker of coronary heart disease.Design and methodsPAPP-A was measured within 24 h following hospital admission in 1448 consecutive patients admitted with diagnoses other than acute coronary syndromes.ResultsPAPP-A was detectable (≥ 4.0 mIU/L) in 278 (19.2%) patients, among whom the mean level was 6.3 mIU/L (95% C.I., 6.1–6.5 mIU/L). The 95 and 99 percentiles for PAPP-A were 7.3 and 9.4 mIU/L, respectively. There was no difference in the mean PAPP-A of different diagnoses (p = 0.33). None of the specific diagnoses known to influence established coronary markers appeared to influence the level of circulating PAPP-A.ConclusionPAPP-A is low in patients without known coronary heart disease. PAPP-A levels seem to be a potentially highly specific marker for heart disease.     

Comparison of Diagnostic Methods for Asperger Syndrome

Several different diagnostic sets of criteria exist for Asperger syndrome (AS), but there is no agreement on a gold standard. The aim of this study was to compare four diagnostic sets of criteria for AS: the ICD-10, the DSM-IV, the Gillberg & Gillberg, and the Szatmari criteria. The series consists of 36 children who had been referred to two centers with a tentative diagnosis of AS. The best agreement was between the ICD-10 and the DSM-IV criteria (Kappa coefficient 0.48), and the lowest between the Gillberg & Gillberg and Szatmari criteria (Kappa coefficient -0.21). The poor agreement between these sets of diagnostic criteria compromises the comparability of studies on AS.     

The SCOFF-c: psychometric properties of the Catalan version in a Spanish adolescent sample

OBJECTIVE: Anxiety sensitivity (AS) is the fear of the physical symptoms of anxiety and related symptoms. Longitudinal studies support AS as a vulnerability factor for development of anxiety disorders. This study aimed to investigate AS as a vulnerability factor in the development of childhood posttraumatic stress disorder (PTSD) following traumatic experiences. METHODS: The study included 81 children 8-15 years of age who experienced the 1999 earthquake in Bolu, Turkey. The earthquake survivors were compared to a randomized group of age- and sex-matched controls 5 years after the earthquake. Both the subject and control groups were administered the Childhood Anxiety Sensitivity Index (CASI), State and Trait Anxiety Inventory for Children (STAI-C), and Child Depression Inventory (CDI), while the PTSD symptoms of the subjects were assessed using the Child Posttraumatic Stress Reaction Index (CPTS-RI). RESULTS: Subjects and controls did not differ significantly in CASI, STAI-C, or CDI scores. Multiple regression analysis showed that both trait anxiety and CASI scores predicted CPTS-RI scores of the subjects; the prediction by CASI scores was over and above the effect of trait anxiety. CONCLUSION: The results of this study support the hypothesis that AS may be a constitutional factor, which might increase the risk of PTSD following traumatic experiences.     

Clinical utility of the PCA3 urine assay in European men scheduled for repeat biopsy

Background

The Prostate CAncer gene 3 (PCA3) assay has shown promise as an aid in prostate cancer (pCA) diagnosis in identifying men with a high probability of a positive (repeat) biopsy.

Objective

This study evaluated the clinical utility of the PROGENSA PCA3 assay.

Design, setting, and participants

This European prospective, multicentre study enrolled men with one or two negative biopsies scheduled for repeat biopsy.

Measurements

After digital rectal examination (DRE), first-catch urine was collected to measure PCA3 mRNA concentration and to calculate the PCA3 score. The PCA3 score was compared to biopsy outcome. The diagnostic accuracy of the PCA3 assay was compared to percent of free prostate-specific antigen (%fPSA).

Results and limitations

In 463 men, the positive repeat biopsy rate was 28%. The higher the PCA3 score, the greater the probability of a positive repeat biopsy. The PCA3 score (cut-off of 35) had a greater diagnostic accuracy than %fPSA (cut-off of 25%). The PCA3 score was independent of the number of previous biopsies, age, prostate volume, and total prostate-specific antigen (PSA) level. Moreover, the PCA3 score was significantly higher in men with high-grade prostate intraepithelial neoplasia (HGPIN) versus those without HGPIN, clinical stage T2 versus T1, Gleason score ≥7 versus <7, and “significant” versus “indolent” (clinical stage T1c, PSA density [PSAD] <0.15 ng/ml, Gleason score in biopsy ≤6, and percent positive cores ≤33%) pCA.

Conclusions

The probability of a positive repeat biopsy increases with rising PCA3 scores. The PCA3 score was superior to %fPSA for predicting repeat prostate biopsy outcome and may be indicative of clinical stage and significance of pCa.     

Validity and reliability of the modified John Hopkins Fall Risk Assessment Tool for elderly patients in home health care

This prospective cohort study was conducted to evaluate the validity and reliability of the modified Johns Hopkins Fall Risk Assessment Tool (mJH-FRAT) among elderly patients receiving home health care visits. Out of 107 patients, 33 (30.8%) had one or more falls and seven (6.5%) experienced falls with injury. Receiver Operating Characteristics of the tool in predicting falls showed an Area Under Curve (AUC) of 0.66 (p = 0.011) with sensitivity and specificity of 72.5% and 52.2% at the cutoff score of 14. For predicting falls with injury, the AUC was 0.82 (p = 0.016) with sensitivity and specificity of 100% and 65.9% at the cutoff score of 17. Inter-rater reliability of the tool was 85.7% agreement with Cohen's kappa of 0.714 (p < 0.001). The mJH-FRAT is a simple and easy-to-use multi-factor fall risk assessment tool with promising sensitivity, specificity and inter-rater reliability for prospectively identifying patients at risk of falls with injury among community-dwelling elderly populations.     

Alanine aminotransferase is an inadequate surrogate marker for detecting lamivudine resistance

AIM: To investigate the accuracy of serum alanine aminotransferase (ALT) in diagnosing lamivudine resistance and factors that contributed to abnormal serum ALT.METHODS: This was a retrospective study of chronic hepatitis B patients on lamivudine therapy who were followed for 3-mo with liver function tests and hepatitis B virus (HBV) DNA measurement. Lamivudine resistance was defined as HBV DNA ≥ 1 log from nadir on at least 2 occasions, confirmed by genotyping. Serum ALT levels in patients with lamivudine r...     

Factors affecting QuickVue Influenza A + B rapid test performance in the community setting

Rapid diagnosis of influenza can facilitate timely clinical management. We evaluated the performance of the QuickVue Influenza A + B test (Quidel, San Diego, CA) in a community setting and investigated the factors affecting test sensitivity. We recruited 1008 subjects from 30 outpatient clinics in Hong Kong between February and September 2007. Each subject provided 2 pooled pairs of nose and throat swabs; 1 pair was tested by the QuickVue rapid test on site, and the other pair was sent to a laboratory for reference tests. Among 998 enrolled subjects with valid results, the rapid test had overall sensitivity of 0.68 and specificity of 0.96 compared with viral culture. Sensitivity for both influenza A and B was significantly higher for specimens with viral loads greater than 5 log₁₀ copies/mL. The QuickVue Influenza A + B test has similar sensitivity in point-of-care community settings to more controlled conditions.