灰区检测在提高血液安全性方面的效用。
The utility of grey zone testing in improving blood safety.
作者信息
Wang Min, Yu Shu-Hong, Han Zong-Zheng
机构信息
Blood Transfusion Department, Hanchuan People's Hospital Hanchuan 431600, Hubei Province, China.
出版信息
Am J Transl Res. 2021 Aug 15;13(8):9771-9777. eCollection 2021.
OBJECT
Transfusion-transmitted infections threaten blood safety. The management of samples with weak reactivity is confusing. Our study aimed to investigate the utility of grey zone (GZ) testing in the screening of the hepatitis B virus (HBV), the hepatitis C virus (HCV), and the human immunodeficiency virus (HIV).
METHODS
Chemiluminescence assays (CLA) were used for the blood screening. For each infectious marker, two CLA kits were used, but for each sample, only one kit was used for each infectious marker. An S/CO ≥ 8.0 was considered reactive, and an S/CO < 0.8 was considered non-reactive. A 0.8 ≤ S/CO < 1.0 was set as GZ1, a 1.0, ≤ S/CO < 4.0 was set as GZ2, and a 4.0 ≤ S/CO < 8.0 was set as GZ3. The samples located at different GZs were separately verified using nucleic acid testing (NAT).
RESULTS
22,081 patients requiring blood transfusions were included in this study. The cohort had an average age of 32.6 ± 10.6 years old. HBV test kit B (0.41% reactivity and 0.58% GZ rate) was more sensitive than kit A (0.28% reactivity and 0.43% GZ rate). HCV test kit A (0.29% reactivity and 0.57% GZ rate) was more sensitive than kit B (0.27% reactivity and 0.31% GZ rate). HIV test kit A (0.10% reactivity and 0.20% GZ rate) was more sensitive than kit B (0.08% reactivity and 0.11% GZ rate). All the samples in GZ1 were negative for NAT. HBV test kit A has negativities of 20.00% and 4.35% in GZ2 and GZ3, respectively, while HBV test kit B has negativities of 36.84% and 35.48% in GZ2 and GZ3, respectively. HCV test kit A has negativities of 100.00% and 66.67% in GZ2 and GZ3, respectively, while HCV test kit B has negativities of 72.73% and 27.78% in GZ2 and GZ3, respectively. HIV test kit A has negativities of 100.00% and 88.24% in GZ2 and GZ3, respectively, while HCV test kit B has negativities of 100.00% and 50.00% in GZ2 and GZ3, respectively.
CONCLUSION
The GZ is useful in blood screening for HBV, HCV, and HIV. A test kit with a high sensitivity has a low specificity. Different test kits should be set with different GZs based on their sensitivity and specificity.
目的
输血传播感染威胁血液安全。对反应性较弱样本的管理存在困惑。我们的研究旨在探讨灰区（GZ）检测在乙型肝炎病毒（HBV）、丙型肝炎病毒（HCV）和人类免疫缺陷病毒（HIV）筛查中的效用。
方法
采用化学发光法（CLA）进行血液筛查。对于每种感染标志物，使用两种CLA试剂盒，但对于每个样本，每种感染标志物仅使用一种试剂盒。S/CO≥8.0被视为反应性，S/CO<0.8被视为非反应性。将0.8≤S/CO<1.0设定为GZ1，1.0≤S/CO<4.0设定为GZ2，4.0≤S/CO<8.0设定为GZ3。使用核酸检测（NAT）分别验证位于不同GZ的样本。
结果
本研究纳入了22081例需要输血的患者。该队列的平均年龄为32.6±10.6岁。HBV检测试剂盒B（反应性0.41%，GZ率0.58%）比试剂盒A（反应性0.28%，GZ率0.43%）更敏感。HCV检测试剂盒A（反应性0.29%，GZ率0.57%）比试剂盒B（反应性0.27%，GZ率0.31%）更敏感。HIV检测试剂盒A（反应性0.10%，GZ率0.20%）比试剂盒B（反应性0.08%，GZ率0.11%）更敏感。GZ1中的所有样本NAT均为阴性。HBV检测试剂盒A在GZ2和GZ3中的阴性率分别为20.00%和4.35%，而HBV检测试剂盒B在GZ2和GZ3中的阴性率分别为36.84%和35.48%。HCV检测试剂盒A在GZ2和GZ3中的阴性率分别为100.00%和66.67%，而HCV检测试剂盒B在GZ2和GZ3中的阴性率分别为72.73%和27.78%。HIV检测试剂盒A在GZ2和GZ3中的阴性率分别为分别为100.00%和88.24%，而HCV检测试剂盒B在GZ2和GZ3中的阴性率分别为100.00%和50.00%。
结论
GZ在HBV、HCV和HIV的血液筛查中有用。灵敏度高的检测试剂盒特异性低。应根据不同检测试剂盒的灵敏度和特异性设置不同的GZ。
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