献血者血液检测策略 ALT 与 HBsAg、HCV-Ab 相关性研究。

Blood test strategy of blood donors, ALT and HBsAg HCV-Ab correlation study.

机构信息

Department of Quality Management, Baoji Central Blood Station of Shaanxi Province, Baoji City, China.

Department of Blood Transfusion, Baoji Central Hospital of Shaanxi Province, Baoji City, China -

出版信息

Minerva Med. 2019 Feb;110(1):18-26. doi: 10.23736/S0026-4806.18.05865-2. Epub 2018 Nov 20.

DOI:10.23736/S0026-4806.18.05865-2

PMID:30458610

Abstract

BACKGROUND

The relationship between ALT and HBsAg and anti-HCV was explored. The effects of different detection methods on blood test results of blood donors were analyzed, and the best blood test mode for blood donors was proposed.

METHODS

Rate method was used to detect ALT, and ELISA was used to detect HBsAg, anti-HCV, anti-TP, and anti-HIV. Negative samples were detected by ELISA for NAT detection (PCR). HBV-NAT-negative specimens and HBV-NAT-positive specimens were detected by electrochemiluminescence for HBsAg, HBs-Ab, HBeAg, HBe-Ab, HBc-Ab (two-and-a-half). The ELISA reagents of different reagent manufacturers were evaluated by serum test disc and quality control method.

RESULTS

The total ALT failure rate of blood donors was 2.48%, of which the single ALT failure rate was 2.45%, accounting for 98.81% (5957/6029). The positive rate of HBsAg was 0.36%, the anti-HCV positive rate was 0.40%, the anti-TP positive rate was 0.46%, and the anti-HIV positive rate was 0.09%. ELISA-negative specimens were detected by NAT, HBV nucleic acid-positive 164 persons, accounting for 0.09%, no HCV, HIV-positive. HBV-NAT positive specimens were detected by nucleic acid quantitative test; the positive rate of HBV-DNA was 56.67%. HCV-positive blood donors were followed up for 24 weeks and re-examined; negative nucleic acid cases accounted for 98.92%. The detection results of serum test disc and quality control method were not the same.

CONCLUSIONS

There was no correlation between ALT positive and HBV and HCV in blood donors. HIV detection are better detection modes by two-pass enzyme elimination and one-time NAT detection (PCR), which can effectively reduce transfusion infection caused by occult infection of HBV and improve blood safety. HBsAg, HCV-Ab positive blood donors after ELISA and nucleic acid test negative after 24 weeks (maximum window period) are recommended to return to the blood donation team to participate in blood donation. The two ELISA reagents were tested by different manufacturers, which were complementary and improved the detection accuracy.

摘要

背景

探讨 ALT 与 HBsAg、抗-HCV 的关系。分析不同检测方法对献血者血液检测结果的影响，提出献血者最佳血液检测模式。

方法

速率法检测 ALT，ELISA 法检测 HBsAg、抗-HCV、抗-TP、抗-HIV。ELISA 阴性标本进行 NAT 检测（PCR）。HBV-NAT 阴性标本和 HBV-NAT 阳性标本用电化学发光法检测 HBsAg、HBs-Ab、HBeAg、HBe-Ab、HBc-Ab（半定量）。采用血清学检测盘和质控方法对不同试剂厂家的 ELISA 试剂进行评估。

结果

献血者 ALT 总失败率为 2.48%，其中单项 ALT 失败率为 2.45%，占 98.81%（5957/6029）。HBsAg 阳性率为 0.36%，抗-HCV 阳性率为 0.40%，抗-TP 阳性率为 0.46%，抗-HIV 阳性率为 0.09%。ELISA 阴性标本经 NAT 检测，HBV 核酸阳性 164 人，占 0.09%，无 HCV、HIV 阳性。HBV-NAT 阳性标本进行核酸定量检测；HBV-DNA 阳性率为 56.67%。对 HCV 阳性献血者进行 24 周随访复查；核酸阴性占 98.92%。血清学检测盘和质控方法的检测结果不一致。

结论

献血者 ALT 阳性与 HBV、HCV 无相关性。双酶联免疫吸附法和单次 NAT 检测（PCR）检测 HIV 是较好的检测模式，可有效降低因 HBV 隐匿性感染导致的输血感染，提高血液安全性。ELISA 和核酸检测后 24 周（最大窗口期）HBsAg、抗-HCV 阳性献血者阴性，建议返回献血队伍参加献血。不同厂家的两种 ELISA 试剂进行检测，互为补充，提高了检测准确性。