关于新生儿疾病筛查血片不合格情况的分析和改进措施

目的分析随州市新生儿疾病筛查血片不合格的原因,制定改进措施,提高血片采集质量,确保新生儿疾病筛查的准确性。方法分析我市2017年-2019年新生儿疾病筛查血片质量不合格情况。结果 2017年-2019年我院共收集血片40 278例,其中不合格血片611例,血片不合格率1.5%,随县地区血片不合格占比明显高于曾都区。我院2017年血片不合格率占2.2%,2018年占1.4%,2019年占1.0%,呈逐年降低趋势。血片质量不合格原因主要由血斑太小、重复滴血、未完全渗透、未干、污染、渗血环、血片信息填写不全造成。结论重视血片采集质量,加强对采血人员的培训,是保证血片质量合格的关键。     

新疆南疆地区2015年度新生儿疾病筛查首次采集血片质量情况分析

目的分析新疆南疆5市37区县2015年度新生儿疾病筛查血片质量情况,探讨南疆地区2015年新生儿疾病筛查不合格血片的原因。方法根据《新生儿疾病筛查血片采集技术规范》对南疆地区2015年新生儿疾病筛查的血片质量进行分析,统计不合格血片数量并分析造成不合格的原因。结果新疆南疆地区2015年度筛查新生儿192 633例,筛查率为62.716%;首次采集血片不合格数5900例,不合格率为3.000%;首次补采血片2029例,平均首次补采率为34.39%;共有六类不合格血片构成,最主要原因是血片污染。结论血片采集是新生儿疾病筛查的重要环节,血片质量是否合格将直接影响新生儿疾病筛查检测结果的准确性,提高血片质量对南疆地区新生儿疾病筛查有重要的意义。     

新疆南疆地区2013年-2015年新生儿疾病筛查血片质量情况分析

目的分析新疆南疆5市37区县2013年-2015年新生儿疾病筛查血片质量整体情况,探讨南疆地区近三年新生儿疾病筛查不合格血片的原因。方法根据《新生儿疾病筛查血片采集技术规范》对新疆南疆地区新生儿疾病筛查的血片质量进行分析,统计不合格血片并分析原因。结果新疆南疆地区近三年共筛查新生儿418 469例,平均筛查率为46.47%;首次采集血片不合格数19 709例,平均不合格率为4.56%;首次补采血片4856例,平均首次补采率为24.64%;集中统计为六类不合格因素,最主要原因是血片污染。结论采集血片是新生儿疾病筛查重要部分,血片质量是否合格将直接影响新生儿疾病筛查检测结果的准确性。提高血片质量对新生儿疾病筛查有重要的意义。     

自贡市无偿献血血液检测不合格率构成分析

目的 分析自贡市献血者血液检测不合格的构成情况,降低血液检测不合格率。方法 分析本市2012~2016年无偿献血者的构成、血液检测不合格情况,对不合格献血者的不合格项目、性别、文化程度进行相关性分析。结果 ①2012~2016年本市血液检测总体不合格率6.51%,不合格率呈逐年降低趋势;②文化程度大专及以上不合格率为1.71%,中等职业不合格率为1.56%,初中及以下文化程度不合格率为3.24%;③男性不合格率3.89%,女性不合格率2.62%;④ALT不合格占总不合格样本的36.01%,HBsAg不合格占总不合格样本的29.81%,两者所占比例最大,其次是抗-TP,占19.63%。结论 ①血液检测不合格的原因主要是ALT和HBsAg不合格,其次是抗-TP;②文化程度越低的献血者血液不合格率越高;③男性献血者血液不合格率大于女性献血者血液不合格率。     

医学实验室标本不合格的情况分析

目的探讨医学实验室标本不合格的特点和原因,以采取预防措施,保证检验质量。方法回顾性分析广东省中医院芳村分院检验科2008-2009年不合格标本的特点和原因。结果不合格标本数为1945份,标本总不合格率为0.65%;所有不合格标本中,血气标本和细菌标本不合格率最高,分别为1.94%和1.98%;不合格标本的主要原因为抗凝标本有凝块、条码错误和标本溶血。结论临床医护人员标本采集操作不规范是造成不合格标本的根本原因,因此,加强对检验标本的采集和处理等分析前质量控制力度显得尤为重要。     

PDCA循环管理在降低临床尿常规检验标本不合格率中的应用

目的探讨PDCA循环管理法在降低临床尿常规检验标本不合格率中的应用效果。方法对首都医科大学附属北京中医医院2017年7月至2018年6月住院患者尿常规检验不合格标本进行数量统计,进一步分析标本不合格原因,随后采用PDCA循环管理法对住院患者尿常规检验标本进行持续性质量改进,比较PDCA循环管理法实施前后的标本不合格率。结果实施PDCA循环管理法后,住院患者尿常规检验标本不合格率显著降低(P<0.05),由实施前的24.18%降为实施后的8.8%,在后期的效果维持阶段,住院患者尿常规检验标本不合格率仍维持在较理想水平(不合格率为9.3%)。结论应用PDCA循环管理法可显著降低住院患者尿常规检验标本不合格率,有效保证检验分析前阶段标本质量,提高检验结果准确性。     

甘肃省部分地区新生儿疾病筛查样本质量情况分析

目的通过分析送往甘肃省新筛中心实验室筛查干血斑样本质量情况,为今后提升我省新生儿筛查样本质量提供参考。方法对2012年~2016年送甘肃省新筛中心实验室进行新生儿疾病筛查的9个地州市干血斑样本,按照年份、送检机构类别、地区探讨送检样本质量情况;并对2016年送检的不合格样本产生原因进行统计分析。结果 (1)5年间共筛查646 812例干血斑样本,不合格8226例,总体不合格率为1.27%,整体呈现下降趋势;按照医院类别统计,新筛干血斑样本不合格率,妇幼专科类医院为1.01%,非妇幼专科类医院为1.45%;临夏州、甘南州送检样本的不合格率在9个地州市中较高,分别为2.47%、2.45%。(2)2016年我实验室收到不合格干血斑样本747例,经不合格原因分析,血斑未渗透为主要原因,占50.47%。结论送往甘肃省新筛中心实验室的干血斑样本质量逐年提高,同时应加强对非妇幼专科类医院及临夏州、甘南州人员培训和督导,尤其强调血斑采集应双面渗透的要求。     

临床尿液常规检验的质量控制分析

目的 分析在临床尿液常规检验中加强质量控制的效果。方法 选取我院检验科2014年1月~2017年12月210例尿液样本,随机分为观察组和对照组,每组105例。对照组采用常规尿液检验法,分析不合格率;观察组在对照组基础上重点加强质量控制工作。对比两组标本的不合格率和出现不合格标本的原因。结果 对照组不合格率为14.29%,高于观察组的0.95%,差异具有统计学意义（P＜0.05）。总共出现16例不合格的情况,导致出现不合格标本出现的主要原因是标本污染5例（31.25%）、标本量不足5例（31.25%）、标本标记不清3例（18.75%）、容器不合格2例（12.50%）、超时送检1例（6.25%）。结论 临床尿液常规检验的质量控制可减少不合格样本的发生,为临床的诊断与治疗提供有价值参考。     

PDCA循环在羊水染色体标本分析前质量改进中的应用

目的应用PDCA循环法来提高羊水染色体分析前标本质量,将羊水染色体标本质量不合格率降到5%以下。方法采用不同病例前-后对照研究,将2018年1月～12月实施PDCA循环前送检的羊水染色体标本251例设为对照组,2019年3月～12月实施PDCA循环后送检的羊水染色体标本368例设为观察组。比较实施PDCA循环前后羊水染色体标本采集不合格率情况。结果实施PDCA循环前,送检的251份羊水标本共有28例不合格,不合格率为11.1%(28/251),而实施PDCA循环后送检的368例羊水标本共有6例不合格,不合格率为1.6%(6/368)。观察组不合格率显著低于对照组,且差异具有统计学意义(χ~2=26.080,P=0.000)。结论 PDCA循环持续改进显著提高送检羊水染色体标本质量,有效降低了羊水染色体标本的不合格率,为获得准确结果提供了分析前质量保证。     

ALT初筛对无偿献血者血液不合格率的影响

目的探讨无偿献血前进行ALT初筛对血液不合格率的影响。方法回顾性分析我中心实施献血前ALT初筛前后9个月的血液检测不合格率，并对ALT淘汰率进行分析。结果实施前ALT不合格率为%，实施后降为%，差异有统计学意义(P<0.05)。实施前ALT不合格数占总不合格数的%，实施后降为%，差异有统计学意义(P<0.05)。结论采取献血前ALT初筛能很好的降低血液不合格率，减少血液浪费。     

Detection of Anti-Hepatitis C virus and Hepatitis C virus RNA in Dried Blood Spot Specimens using Whatman no. 1 Filter Paper

Purpose: Dried blood spot (DBS) specimen simplifies blood collection, processing, storage and shipment and may reduce the cost of testing for hepatitis C virus (HCV) infection. We wanted to see if DBS using a cheap filter paper is reliable alternative to serum for detection of anti-HCV and HCV RNA. Materials and Methods: At a tertiary care hospital in Northeast India, we collected 91 paired DBS and serum specimens from patients at risk of HCV infection from July 2014 to June 2015. DBS was collected on Whatman No. 1 filter paper. After processing, the specimens were subjected to anti-HCV detection by a third-generation Enzyme-Linked Immunosorbent Assay (ELISA). The reactive DBS and serum specimens were further subjected to HCV RNA detection by polymerase chain reaction. The results were analysed in paired screen-positive study design. Results: Anti-HCV was detected in 9 (9.9%) DBS specimens and 10 (10.9%) serum specimens. There was statistically significant (P < 0.0001) correlation between the optical density values of DBS and serum specimens (Pearson r = 0.9181, 95% confidence interval: 0.8781–0.9453). HCV RNA was detected in 5/9 (55.6%) reactive DBS and 9/10 (90.0%) reactive serum specimens. There was no correlation between HCV RNA levels in the DBS and the serum specimens. The relative sensitivity rate and the relative false-positive rate of DBS anti-HCV ELISA were 0.89 and 1.00, respectively. Conclusions: DBS using Whatman No. 1 filter paper is quite reliable as serum for detection of anti-HCV. It can be useful in effective surveillance. However, it is not suitable for confirmation of chronic HCV infection.     

Detection of human immunodeficiency virus type 1 (HIV-1) in heel prick blood on filter paper from children born to HIV-1-seropositive mothers.

The human immunodeficiency virus type 1 (HIV-1) DNA PCR results of 94 dried blood spot (DBS) samples on filter paper and corresponding venous blood in EDTA obtained from infants born to HIV-1-seropositive mothers were compared. In addition, the results of HIV-1 DNA PCR on DBS and the HIV-1 RNA PCR from plasma of 70 paired samples were compared. A 100% specificity and a 95% sensitivity for HIV-1 DNA PCR on DBS compared with results for venous blood were observed for the 94 paired samples. The results of the DBS HIV-1 DNA PCR and HIV-1 RNA PCR of 70 corresponding plasma samples correlated perfectly (100%). The DBS HIV-1 DNA PCR method proved reliable for HIV-1 detection.     

应用荧光斑点法和G6PD/6PGD比值法检测新生儿G6PD

目的建立适合于G6PD缺乏的新生儿筛查及确诊方法。方法应用荧光斑点法(FST)对新生儿筛查滤纸干血片进行检测,对可疑阳性者召回,抽静脉血以G6PD/6PGD比值法进行确诊,同时结合新生儿父母亲的G6PD结果 ,根据遗传关系综合分析。结果 FST筛查95471例新生儿,G6PD缺乏阳性率为4.53%(4321/95471),G6PD/6PGD比值法确诊检出率为4.20%(4009/95471),与比值法的符合率为92.78%,G6PD重度缺乏者的符合率为100%,G6PD中间缺乏者的符合率为86.13%,室间质量控制结果与反馈结果符合率为100%。结论 FST具有高的敏感性、特异性和准确性,方法简便、快捷、费用低廉,可对滤纸干血片标本进行大规模的筛查检测,同时利用比值法进行确诊,适宜在高发区开展G6PD缺乏的新生儿筛查和早期诊断及防治工作中应用。     

Dried blood spots versus sera for detection of rubella virus-specific immunoglobulin M (IgM) and IgG in samples collected during a rubella outbreak in Peru

Most persons with rubella virus-specific immunoglobulin M (IgM)- or IgG-positive sera tested positive (98% [n = 178] and 99% [n = 221], respectively) using paired filter paper dried blood spot (DBS) samples, provided that DBS indeterminate results were called positive. For persons with IgM- or IgG-negative sera, 97% and 98%, respectively, were negative using DBS.     

Evaluation of the Abbott Real-Time HIV-1 quantitative assay with dried blood spot specimens

The Abbott Real-Time HIV-1 assay was evaluated for its performance in quantification of human immunodeficiency virus type 1 (HIV-1) RNA in dried blood spot (DBS) samples. In total, 169 blood samples with detectable plasma HIV-1 RNA were used to extract RNA from paired DBS and liquid plasma samples, using the automated Abbott m Sample Preparation System (m2000sp). HIV-1 RNA was then quantitated by the m2000rt RealTime analyser. RNA samples suitable for real-time PCR were obtained from all but one (99.4%) of the DBS samples and HIV-1 RNA was detected in 163/168 (97.0%) samples. The correlation between HIV-1 RNA values measured in paired DBS and plasma samples was very high ( r  = 0.882), with 78.5% and 99.4% of cases differing by <0.5 and 1.0 log, respectively. Retesting of DBS replicates following 6 months of storage at 2–8°C showed no loss of HIV-1 RNA in a subset of 89 samples. The feasibility of DBS testing coupled with automated sample processing, and the use of a latest-generation FDA-approved real-time PCR-based system, represents an encouraging first step for viral load measurement in reference centres in developing countries where access to antiretroviral therapy is expanding.     

Usefulness of a genotypic resistance test using dried blood spot specimens in African HIV-infected children with virological failure according to the 2010-revised WHO criteria

We compared paired plasma and dried blood spot (DBS) samples from 54 HIV-1-treated children living in Bangui, Central African Republic, for antiretroviral-resistance-associated mutations. All children displayed virological failure (HIV-1 RNA >3.70 log₁₀copies/ml). Testing for resistance genotype was carried out in a reference laboratory in Paris, France. A successful test result was obtained in 54 (100%) plasmas and 25 DBSs (46%). Among the 732 resistance-associated mutations analyzed, 718 were identical, leading to a high concordance rate of 98.1%. Genotypic resistance tests on DBS samples were found to be highly feasible and accurate in a foreign reference laboratory, but with additional costs for shipping and decreased sensitivity.     

Field Study of Dried Blood Spot Specimens for HIV-1 Drug Resistance Genotyping

Dried blood spots (DBS) are an alternative specimen type for HIV drug resistance genotyping in resource-limited settings. Data relating to the impact of DBS storage and shipment conditions on genotyping efficiency under field conditions are limited. We compared the genotyping efficiencies and resistance profiles of DBS stored and shipped at different temperatures to those of plasma specimens collected in parallel from patients receiving antiretroviral therapy in Uganda. Plasma and four DBS cards from anti-coagulated venous blood and a fifth card from finger-prick blood were prepared from 103 HIV patients with a median viral load (VL) of 57,062 copies/ml (range, 1,081 to 2,964,191). DBS were stored at ambient temperature for 2 or 4 weeks or frozen at −80°C and shipped from Uganda to the United States at ambient temperature or frozen on dry ice for genotyping using a broadly sensitive in-house method. Plasma (97.1%) and DBS (98.1%) stored and shipped frozen had similar genotyping efficiencies. DBS stored frozen (97.1%) or at ambient temperature for 2 weeks (93.2%) and shipped at ambient temperature also had similar genotyping efficiencies. Genotyping efficiency was reduced for DBS stored at ambient temperature for 4 weeks (89.3%, P = 0.03) or prepared from finger-prick blood and stored at ambient temperature for 2 weeks (77.7%, P < 0.001) compared to DBS prepared from venous blood and handled similarly. Resistance profiles were similar between plasma and DBS specimens. This report delineates the optimal DBS collection, storage, and shipping conditions and opens a new avenue for cost-saving ambient-temperature DBS specimen shipments for HIV drug resistance (HIVDR) surveillances in resource-limited settings.     

多参数监护仪的质控检测初探

目的通过对多参数监护仪的质控工作,掌握在用多参数监护仪的性能现状,提高其使用的安全性和准确性。方法心脏重症监护病房（CCU）的24台某品牌多参数监护仪。采用Fluke专业的质控设备对多参数监护仪的电气安全、心电、血氧、血压、呼吸等进行检测。结果一次合格率为75％,二次合格率为95．8％,其中心率检测有3台不合格,无创血压检测有2台不合格．血氧饱和度检测有2台不合格：不合格主要原因是心电导联线、袖带、血氧探头的老化。结论加强医疗设备的质量控制关系重大．要制定合理的质控方案,确保医疗设备的安全性和准确性。     

Use of dried blood spots for the detection and confirmation of HTLV-I specific antibodies for epidemiological purposes.

AIMS--To modify and evaluate a gelatin particle agglutination test that could provide a sensitive, specific and inexpensive method for the detection of HTLV-I antibody in dried blood spot samples (DBS) collected on filter paper. METHODS--A set of 26 reference samples confirmed as HTLV-I antibody positive were assembled from patients with tropical spastic paraparesis or adult T cell leukaemia and blood donors. Serum samples and simulated antibody positive dried blood spot eluates were tested using the Serodia assay together with two confirmatory tests: HTLV BLOT 2.3, a western blot, and Select-HTLV, an enzyme immunoassay (EIA). Both confirmatory tests use synthetic peptides to differentiate between antibodies to HTLV-I and -II. The modified Serodia assay was then used to test anonymously 10,135 DBS collected from neonates from London. Samples reactive in the modified Serodia test producing a positive result were titrated to an end point and confirmed as before. RESULTS--All 26 eluates made from simulated DBS derived from positive reference samples were identified as positive by the modified Serodia HTLV-I test and were confirmed as anti-HTLV-I positive by EIA. Two eluates derived from relatively low titre reference samples gave indeterminate results on western blotting. Screening of the 10,135 neonatal DBS resulted in six repeat reactives, five of which were confirmed. The remaining reactive sample gave an indeterminate result on western blotting and there was insufficient eluate for testing by EIA. The overall seroprevalence of HTLV-I in this population was 0.05% (five of 10,135). CONCLUSION--The modified Serodia HTLV-I assay provides a sensitive, specific and inexpensive (10 pence/test) method for screening large numbers of DBS. The format of the assay makes it ideally suited for simultaneous screening of antibodies to HIV-1, HIV-2 and HTLV-I using semi-automated equipment.