| Objective To understand the difference between Roche’s Cobas PCR reagent and domestic HBV fluorescent quantitative PCR reagents for HBV DNA detection,so as to better guide antiviral treatment.method:Collected 70 sera from patients with chronic hepatitis B or hepatitis B cirrhosis who had not been and had been treated with nucleosides in outpatient and inpatient hospitals between March 2019 and June 2019 in Anyi University First Affiliated Hospital,and the correlation was used.Analysis to evaluate the accuracy of Cobas test and domestic test on different HBV DNA load specimens.HBV DNA quantitative detection: HBV DNA was detected using Cobas Quantitative Reagent(Roche)and Shanghai Zhijiang Biological Technology Co.,Ltd.Reagent(ZJ).The amplification reactions were performed on a Cobas Taq Man 48 PCR instrument and an ABI 7500 gene amplification instrument produced by Applied Biosystem of the United States.The same sample is tested in parallel with two reagents.For specific operations and results,refer to the kit instructions.result:1.The overall correlation coefficients between the test results of the reagent ZJ reagent produced by Shanghai Zhijiang Biotechnology Co.,Ltd.and the results of Roche test were r = 0.612,P = 0.004,indicating a significant linear correlation between the two.2.It can be seen that in the range of 103 <HBV DNA ≤ 106,the P value is greater than0.05,indicating that there is no significant correlation between the two test methods.Above the HBV DNA> 107 copy / ml range,there is a significant linear correlation between the two test methods..3.ZJ reagent test results ≤ 1000 copy / ml and Roche test results> 1000 copy / ml,that is,16 cases of false negative ZJ reagent test results,accounting for 37.2%Conclusions1.The results of testing research show that the ZJ reagent and Roche reagent have a good correlation,indicating that domestic reagents generally reflect the viral load level in the specimen and can be used for routine testing.However,it was found that the ZJ reagent only had a good correlation with the specimens with a viral load of more than107 copy / ml,and the specimens with a viral load of less than 106 copy / ml had a poor correlation.2.The test results of domestic reagents for specimens with viral load lower than 106 copy / ml are prominently reflected in three aspects: 1)the accuracy of the test results is poor;2)a significant percentage of specimens with domestic reagents have a test value of ≤1000 copy / ml The lower the viral load,the higher the percentage of detection values below the lower limit.3)For specimens with a viral load below 106 copy / ml,the repeatability of the test results of domestic reagents is poor,and the test results of different batches of the same specimen can differ by an order of magnitude.3.The Cobas system is the most accurate virus detector and it has become the gold standard for detecting HBV-DNA internationally.4.Serum HBV DNA ≥10 ^ 4 copy / ml increases the risk of disease progression and liver cancer.It is a risk factor that is completely independent of e antigen status and serum alanine aminotransferase levels.Therefore,the disease progression and increased risk of liver cancer when serum HBV DNA is ≥10 ^ 4 copy / ml is a risk factor and node that is completely independent of e antigen status and serum alanine aminotransferase levels.5.It is recommended that for specimens with HBV DNA below 106 copy / ml,especially those that are tested below the lower detection limit after antiviral treatment,Cobas high-precision viral load detection system should be used for testing or retesting to avoid false test.Negative results delay the patient’s condition. |
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