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目的某院将HBV血清标志物检测方法由ELISA法更换为微粒子化学发光免疫分析(ARCHITECT-i4000)检测后,依据ARCHITECT i系统给定的参考值判定结果,发现临床乙肝核心抗原(HBc Ab)阳性率显著增高。本研究旨在探讨ARCHITECT-i4000检测HBc Ab阳性结果的意义。方法先将所有血清标本用ARCHITECT-i4000检测,再将其中HBs Ag为阴性且HBc Ab为阳性标本的血清(30倍稀释或不稀释)用ELISA法检测。结果用原倍血清(作为流行病学调查依据),ELISA法与RCHITECT-i4000法检测HBc Ab的阳性符合率为100.00%;ELISA法采用生理盐水30倍稀释的标本(作为临床诊断依据)检测,阳性符合率仅为43.97%。ELISA检测为阳性标本的ARCHITECT-i4000检测值(S/CO,9.25±1.23)明显高于阴性标本(S/CO,4.88±2.35),P<0.001。将ARCHITECT-i4000检测值在1.0~8.10 S/CO之间判为阴性,HBs Ab+HBc Ab+模式中HBc Ab的阳性符合率仅有18.8%,而“大三阳”和“小三阳”的阳性符合率可高达95.5%。结论 ARCHITECT-i4000用原倍血清检测HBc Ab,其检测的阳性结果 S/CO值在1.0~8.10可能更具有流行病学调查的意义。
OBJECTIVE Objective To determine the clinical significance of hepatitis B virus (HBcAb) -positive antigen (HBcAb) in a hospital based on the reference value judgment given by ARCHITECT i system after the detection method of HBV serological marker was changed from ELISA to ARCHITECT-i4000. The rate was significantly higher. The purpose of this study was to investigate the significance of ARCHITECT-i4000 in detecting HBc Ab positive results. Methods All serum samples were detected with ARCHITECT-i4000, and then the serum (30-fold diluted or undiluted) with HBsAg-negative and HBc-Ab positive was detected by ELISA. Results The positive coincidence rate of ELISA and RCHITECT-i4000 method for detecting HBc Ab was 100.00% with the original times serum (based on the epidemiological survey). The ELISA method was used to detect 30 times dilution of normal saline (for clinical diagnosis) Positive coincidence rate of only 43.97%. ARCHITECT-i4000 detected by ELISA (S / CO, 9.25 ± 1.23) was significantly higher than that of negative samples (S / CO, 4.88 ± 2.35), P <0.001. The ARCHITECT-i4000 detection value was negative between 1.0 ~ 8.10 S / CO, and the positive coincidence rate of HBc Ab in HBs Ab + HBc Ab + mode was only 18.8%, while the positive values of “Big Three” and “ ”The positive coincidence rate can be as high as 95.5%. CONCLUSION ARCHITECT-i4000 can detect HBc Ab with original serum in the range of 1.0-8.10, which may be of more significance for epidemiological investigation.