Clinical role of HBV RNA detection in chronic hepatitis B

doi:10.3969/j.issn.1673-8640.2022.01.015

Abstract

Abstract:

Objective To evaluate the performance of a method for the detection of hepatitis B virus（HBV） RNA,to compare serum HBV RNA levels in patients with different results of serological markers of HBV infection,and to evaluate the relationship between HBV RNA and HBV DNA. Methods The performance of the method for HBV RNA detection was evaluated,which included precision,sensitivity and linearity. The sera of 81 patients with hepatitis B surface antigen（HBsAg）-positive chronic hepatitis B were collected,and the levels of HBV RNA,HBV DNA and serological markers were detected simultaneously. The patients were classified according to the different results of hepatitis B e antigen（HBeAg）,serological markers of HBV infection and medication. Results The intra-assay precisions of high and low HBV RNA values were 0.56% and 2.30%,and the inter-assay precisions were 3.13% and 6.03%,respectively,which all met the clinical requirements. The sensitivity of the assay was achieved by repeating the assay 20 times for samples close to the lower limit of detection stated by the manufacturer,and the detection rate was 100%,which met the clinical requirement. It was linear in the range of HBV RNA 1.0×10²-1.0×10⁷ copies/mL. Serum HBV RNA and HBV DNA loads in HBeAg-positive group were higher than those in HBeAg-negative group（P<0.01,P<0.05）,and the HBeAg-positive and hepatitis B e antibody（HBeAb）-negative group had the highest HBV RNA loads among all the groups with different results of serological markers of HBV infection（P<0.01）. Serum HBV DNA and HBV RNA loads were higher in untreated group than those in treated group（P<0.01,P<0.05）. In 81 patients with chronic hepatitis B,HBV RNA loads were positively correlated with HBV DNA load and HBeAg positive titer（r=0.348 and 0.544,respectively,P<0.05） and without HBsAg titer（r=0.04,P>0.05）. In HBeAg-positive patients with chronic hepatitis B,serum HBV RNA loads were positively correlated with serum HBV DNA load（r=0.338,P<0.05）. In HBeAg-negative patients with chronic hepatitis B,serum HBV RNA levels did not correlate with serum HBV DNA load（r=0.14,P>0.05）. Conclusions Serum HBV RNA level is a potential new marker for monitoring the viral activity and therapeutic efficacy of HBV infection.

Key words: Hepatitis B virus RNA, Hepatitis B virus DNA, Chronic hepatitis B

CLC Number:

R446.7

MA Yanting, SU Xi, HUANG Fei, WANG Mengxian, SHEN Minna, ZHANG Chunyan, WANG Beili, PAN Baishen, GUO Wei. Clinical role of HBV RNA detection in chronic hepatitis B[J]. Laboratory Medicine, 2022, 37(1): 72-77.

Figures/Tables 6

References 20

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样本	批内精密度			批间精密度
样本	均值/（拷贝/mL）	标准差/（拷贝/mL）	CV/%	均值/（拷贝/mL）	标准差/（拷贝/mL）	CV/%
高值	2.51×10⁵	1.41×10³	0.56	5.62×10⁵	1.76×10⁴	3.13
低值	1.10×10³	2.53×10¹	2.30	1.41×10³	8.50×10¹	6.03

样本	批内精密度			批间精密度
样本	均值/（拷贝/mL）	标准差/（拷贝/mL）	CV/%	均值/（拷贝/mL）	标准差/（拷贝/mL）	CV/%
高值	2.51×10⁵	1.41×10³	0.56	5.62×10⁵	1.76×10⁴	3.13
低值	1.10×10³	2.53×10¹	2.30	1.41×10³	8.50×10¹	6.03

样本编号	稀释倍数	理论值/ （拷贝/mL）	实测值/ （拷贝/mL）
1	0	2.20×10⁷	2.19×10⁷
2	10	2.20×10⁶	2.72×10⁶
3	100	2.20×10⁵	2.15×10⁵
4	1 000	2.20×10⁴	1.85×10⁴
5	10 000	2.20×10³	2.03×10³
6	100 000	2.20×10²	1.89×10²

样本编号	稀释倍数	理论值/ （拷贝/mL）	实测值/ （拷贝/mL）
1	0	2.20×10⁷	2.19×10⁷
2	10	2.20×10⁶	2.72×10⁶
3	100	2.20×10⁵	2.15×10⁵
4	1 000	2.20×10⁴	1.85×10⁴
5	10 000	2.20×10³	2.03×10³
6	100 000	2.20×10²	1.89×10²

组别	例数	HBV RNA/（拷贝/mL）	HBV DNA/ （拷贝/mL）
HBeAg阳性组	40	1.2×10⁴（9.8×10²~3.0×10⁵）	8.0×10²（0~3.3×10⁵）
HBeAg阴性组	41	0 （0~2.7×10²）	0 （0~3.6×10³）
Z值		-5.866	-1.974
P值		0.000 1	0.048