Comparison of three blood collection tubes for 16 biochemical analytes and stability assessment of selected analytes: VACUETTE® CAT serum Sep clot activator tube, VACUETTE® LH lithium heparin Sep tube, and VACUETTE® CAT serum fast separator tube.

IF 2.1 4区 医学 Q3 MEDICAL LABORATORY TECHNOLOGY
Jong Do Seo, Yeon Jae Lee, Changhee Ha, Ju Hee Choi, Seon-Hyeon Shin, Hye Young Han, Hyun-Joong Kim, Sung Hea Kim, Bum Sung Kim, Hanah Kim, Hee-Won Moon, Mina Hur, Yeo-Min Yun
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引用次数: 0

Abstract

BackgroundAnalytical performance of VACUETTE® CAT Serum Fast Separator Tube (SFT; Greiner Bio-One, Austria), recently developed quick-clotting serum separator, was evaluated for correlation and stability, comparing with VACUETTE® CAT Serum Sep Clot Activator Tube (SST; Greiner Bio-One) and VACUETTE® LH Lithium Heparin Sep Tube (LiHep Tube; Greiner Bio-One).MethodFor 107 paired samples, 16 analytes (glucose, potassium, LDH, CRP, creatinine, AST, ALT, ALP, GGT, AFP, PSA, TSH, free T4, iPTH, CK-MB, and cardiac troponin I[cTnI]) were measured. Correlations were assessed using Passing-Bablok regression and paired t-tests. Differences were evaluated by comparing the mean percentage difference and estimated difference at medical decision limits (MDLs), to the acceptable desirable difference. For six analytes - glucose, potassium, LDH, AST, iPTH, and cTnI - known for different stabilities between sample types, stability was evaluated by comparing changes over time with desirable differences.ResultsAcross the evaluated range, SFT showed clinically comparable differences to SST, except for CK-MB which showed significant positive bias. Plasma exhibited unacceptable biases: negative for potassium and positive for LDH and CK-MB. Estimated differences at MDLs were acceptable in SFT except for potassium and CK-MB, while plasma showed unacceptable differences in potassium, LDH, creatinine, and CK-MB. LiHep Tube showed reduced stability than SST for all analytes except for iPTH, impairing retest reliability. SFT showed comparable stability except for LDH and iPTH, which showed slightly shortened stability.ConclusionsThe SFT demonstrated high correlation and comparable stability to SST, making it a suitable replacement for the LiHep Tube, as an alternative to SST for rapid testing.

用于16种生化分析物的三种采血管的比较及所选分析物的稳定性评价:VACUETTE®CAT血清Sep凝块激活管、VACUETTE®LH锂肝素Sep管和VACUETTE®CAT血清快速分离管。
VACUETTE®CAT血清快速分离管的分析性能Greiner Bio-One, Austria),最近开发的快速凝血血清分离器,通过与VACUETTE®CAT血清Sep凝血激活管(SST;Greiner Bio-One)和VACUETTE®LH锂肝素Sep管(LiHep管;他一一Bio-One)。方法对107份配对样品测定16项指标(葡萄糖、钾、LDH、CRP、肌酐、AST、ALT、ALP、GGT、AFP、PSA、TSH、游离T4、iPTH、CK-MB、心肌肌钙蛋白I[cTnI])。使用passingbablok回归和配对t检验评估相关性。通过比较医疗决策极限(mdl)的平均百分比差异和估计差异与可接受的理想差异来评估差异。对于六种分析物-葡萄糖,钾,LDH, AST, iPTH和cTnI -已知在样品类型之间具有不同的稳定性,稳定性通过比较随时间的变化与期望的差异来评估。结果在整个评估范围内,SFT与SST具有临床可比性差异,但CK-MB表现出显著的正偏倚。血浆表现出不可接受的偏差:钾呈阴性,LDH和CK-MB呈阳性。除了钾和CK-MB外,SFT中mdl的估计差异是可以接受的,而血浆中钾、LDH、肌酐和CK-MB的差异是不可接受的。除了iPTH外,LiHep Tube对所有分析物的稳定性都低于SST,从而降低了重测的可靠性。除了LDH和iPTH的稳定性稍短外,SFT的稳定性与LDH相当。结论SFT与SST具有较高的相关性和稳定性,是LiHep Tube的合适替代品,可以替代SST进行快速检测。
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来源期刊
Annals of Clinical Biochemistry
Annals of Clinical Biochemistry Biochemistry, Genetics and Molecular Biology-Clinical Biochemistry
CiteScore
5.20
自引率
4.50%
发文量
61
期刊介绍: Annals of Clinical Biochemistry is the fully peer reviewed international journal of the Association for Clinical Biochemistry and Laboratory Medicine. Annals of Clinical Biochemistry accepts papers that contribute to knowledge in all fields of laboratory medicine, especially those pertaining to the understanding, diagnosis and treatment of human disease. It publishes papers on clinical biochemistry, clinical audit, metabolic medicine, immunology, genetics, biotechnology, haematology, microbiology, computing and management where they have both biochemical and clinical relevance. Papers describing evaluation or implementation of commercial reagent kits or the performance of new analysers require substantial original information. Unless of exceptional interest and novelty, studies dealing with the redox status in various diseases are not generally considered within the journal''s scope. Studies documenting the association of single nucleotide polymorphisms (SNPs) with particular phenotypes will not normally be considered, given the greater strength of genome wide association studies (GWAS). Research undertaken in non-human animals will not be considered for publication in the Annals. Annals of Clinical Biochemistry is also the official journal of NVKC (de Nederlandse Vereniging voor Klinische Chemie) and JSCC (Japan Society of Clinical Chemistry).
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