Evaluation of Seven Rapid Diagnostic Tests for Detection of Hepatitis C Virus Antibodies in China

Bing Chen; Zhong-Hui Ma; Bing Xu; Hao Chang; Xiao-Xia He; Li-Jian Pei; Ya-Nan Ren; Wen-Ge Xing

Disclosures

J Viral Hepat. 2021;28(4):657-663. 

In This Article

Results

Results of HCV Basic Serum Panel

The set of HCV basic panel was used to evaluate clinical sensitivity, clinical specificity, PPV and NPV of HCV RDT kits. As shown in Table 1, the results showed that the clinical sensitivity of all HCV RDT reagents were between 94% (95% CI: 83.2–98.6) and 100% (95% CI: 91.5–100), and the clinical specificity ranged from 96% (95% CI: 85.8–99.7) to 100% (95% CI: 91.5–100). Moreover, the PPV and NPV were calculated according to clinical sensitivity, clinical specificity, and HCV prevalence in different population. The results showed that the NPV of all RDT reagents were higher than 99.9% at different HCV prevalence. And the PPV of C and D reagents was 100% in different prevalence, while the PPV of the other five reagents was lower than 25% when the HCV prevalence was 0.5%, the PPV ranged from 20.16% to 33.56% in 1.0% prevalence of HCV, and the PPV ranged from 73.53% to 84.75% in 10.0% prevalence of HCV (Table 1).

Results of HCV Seroconversion Panel

The HCV seroconversion panel was used to evaluate analytical sensitivity of HCV RDT reagents in early detection of antibodies. For each seroconversion panel, the first specimen in the sequence to become reactive with Murex4.0 HCV was assigned the value '0'. Results from HCV RDT under evaluation were compared with Murex4.0 HCV by the relative position. If a HCV RDT reagent became reactive one specimen earlier in a seroconversion panel than Murex 4.0 HCV, the value assigned for this panel in the RDT reagent was '+1'. Similarly, if a RDT reagent became reactive two specimens later than Murex 4.0 HCV, the value assigned was '−2'. As shown in Figure 1. It can be found that the E and G reagents were more sensitive in early detection of antibodies compared with the other five HCV RDT reagents and compared to the reference assays. While the early detection of B, C, D and F reagents was weak, which was less than the detection time of Murex HCV 4.0.

Figure 1.

Relative Performance of HCV RDT reagents in Seroconversion Panels compared to Reference Assay (Murex 4.0 HCV)

Results of HCV Analytical Specificity Panel

The set of HCV analytical specificity panel was used to evaluate analytical specificity of HCV RDT kits. The results showed that the analytical specificity of A, B, D, E, F, and G kits were all 100% (95% CI: 90.6–100), and no false-positive result was found. While the analytical specificity of C kit was 97.8% (95% CI: 87.4–100), and the result of a haemolytic specimen was false positive by C kit. Thus, these HCV RDT kits had no cross-reactivity with haemoglobin, triglycerides, and other viral infections, such as HIV, HBV and syphilis (see Table 2).

Results of HCV Mixed Titre Performance Panel

The set of mixed titre performance panel was used to evaluate the detection ability of HCV RDT kits with different antibody titres. The reference results with different antibody titres were tested by anti-HCV ELISA (Beijing WANTAI Biological Pharmacy Enterprise Co.Ltd). As shown in Table 3. The M7 specimen in HCV mixed titre performance panel was confirmed to be negative, and the results of six HCV RDT kits exhibited negative, except for weak-positive result of E reagent. In addition, the M4, M5, and M6 specimens were tested by reference assay with low S/CO, and it could not be fully detected by C, D, and F kits. Moreover, the results of A, B, and G kits were consistent with the reference results (see Table 3).

Results of HCV Genotype Qualification Panel

The set of HCV genotype qualification panel was used to evaluate the detection ability of HCV RDT kits with different HCV genotypes. As shown in Table 4. It can be observed that all of the seven HCV RDT reagents can detect the HCV genotype 1b, 2a, 3a, 4a, 5a and 6. But the specimens of HCV subtypes 1a and/or 2b were not detected by all HCV RDT kits, except that the specimen of subtype 2b was detected by C kit (see Table 4).

Results of HCV Characteristic Panel

The set of HCV characteristic panel was used to evaluate the detection ability of HCV RDT kits to different bands. The results exhibited that the 20 specimens with different bands in HCV characteristic panel were detected by B kit. However, the P4 and/or P5 specimens in this panel were not detected by other six kits. The RIBA results showed that the P4 and P5 specimens had single bands with only NS4-1 bands (see Table 5).

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