Received: 9 February 2018 | Accepted: 5 June 2018

DOI: 10.1002/jcla.22600

RESEARCH ARTICLE

Performance evaluation of the mindray anti-­HCV assay for the

detection of hepatitis C virus infection

Zhi-hong Yue | Chang-sheng Xia | Hui Wang

Department of Clinical Laboratory, Peking

University People’s Hospital, Beijing, China Background: Anti-­hepatitis C virus (anti-­HCV) antibody assays are recommended for
HCV infection screening. The Mindray anti-­HCV assay, based on a third-­generation
Correspondence
Hui Wang, Department of Clinical immunoassay, was recently launched in China. We aimed to evaluate its diagnostic
Laboratory, Peking University People’s performance compared with that of two other widely used assays.
Hospital, Beijing, China.
Email: [email protected] Methods: Six HCV infection seroconversion panels were used to evaluate the sensi-
tivity of the assay for early detection. A total of 1952 clinical samples were tested by
Funding information
This work was supported by the National the Mindray anti-­HCV, Elecsys anti-­HCV II, and Architect anti-­HCV assays. Samples
Development and Reform Commission of
with reactive results using at least one anti-­HCV assay were further tested with the
China (grant number: 2127000068).
recombinant immunoblot assay (RIBA). Inconsistent results were investigated by the
HCV RNA assay and HCV core antigen assay. HCV infection diagnosis was made ac-
cording to the results of laboratory tests and medical records.
Results: The Mindray anti-­HCV assay and Elecsys anti-­HCV II assay detected se-
roconversion in an average of 12.5 days and 10.5 days, respectively, and this dif-
ference was not significant (P = .818). Of the 1952 cases, 90 were categorized as
“HCV infection” and 1862 were categorized as “no HCV infection.” The sensitivity,
specificity, positive predictive value (PPV), negative predictive value (NPV), posi-
tive likelihood ratio (LR+), and negative likelihood ratio (LR-­) of each assay were as
follows: the Mindray anti-­HCV assay, 95.6%, 99.2%, 85.1%, 99.8%, 118.6 and
0.045, respectively; the Architect anti-­HCV assay, 98.9%, 95.2%, 50.0%, 99.9%,
20.69 and 0.012, respectively; and the Elecsys anti-­HCV II assay, 96.7%, 99.9%,
98.9%, 99.8%, 1799.9 and 0.033, respectively. There were significant differences
in the specificity, PPV and LR+ among the three assays (P < .001). There were no
significant differences in the sensitivity, NPV or LR-­ among the three assays
(P > .05).
Conclusions: The Mindray anti-­HCV assay displays a similar sensitivity to the Elecsys
anti-­HCV II assay with respect to the early detection of HCV infection. The Mindray
anti-­HCV assay shows excellent diagnostic performance and is suitable for the
screening of HCV infection.

KEYWORDS
anti-HCV, Architect anti-HCV assay, diagnostic performance, Elecsys anti-HCV II assay,
hepatitis C virus, Mindray anti-HCV assay

Zhi-hong Yue and Chang-sheng Xia contributed equally to this work and should be considered as co-first authors.

J Clin Lab Anal. 2018;32:e22600. wileyonlinelibrary.com/journal/jcla © 2018 Wiley Periodicals, Inc. | 1 of 7

https://doi.org/10.1002/jcla.22600
2 of 7 | YUE et al.

1 | I NTRO D U C TI O N The results from all three anti-­HCV assays are expressed as
signal-­to-­cut-­off (S/CO) ratios, with a S/CO ratio of < 1.0 indicating
Hepatitis C is a liver disease caused by the hepatitis C virus (HCV). a nonreactive result and a S/CO ratio of ≥ 1.0 indicating a reactive
According to the Global Hepatitis Report (WHO, 2017), approxi- result. The tested samples that were initially reactive were retested
mately 71 million people worldwide have chronic HCV infection and in duplicate. If one or both duplicates were reactive, the result was
399 000 people die each year from hepatitis C, mostly from cirrhosis considered anti-­HCV antibody CLIA-­reactive, and S/CO levels corre-
or hepatocellular carcinoma.1 sponded to the antibody concentration.
Although direct-­acting antiviral treatment for HCV is becoming All anti-­HCV antibody CLIA-­reactive samples according to at
simpler and more effective, HCV infection is asymptomatic in the ma- least one assay were further tested using the RecomLine HCV IgG
jority of patients; thus, it remains difficult to diagnose clinically until strip immunoassay (Mikrogen GmbH, Neuried, Germany). The re-
more advanced stages of fibrosis are present.2,3 HCV infection diag- combinant immunoblot assay (RIBA) results are expressed as neg-
nosis relies heavily on clinical laboratory tests, including anti-­HCV ative, indeterminate or positive. Samples that yielded negative or
antibody detection, detection of HCV core antigen (HCVcAg), and indeterminate results in the RIBA were further investigated by NAT
4,5
nucleic acid testing (NAT) for HCV RNA. In clinical practice, HCV (COBAS CAP/CTM V2, Roche Diagnostics, Almere, the Netherlands)
infection diagnosis is a two-­step process that starts with an anti-­HCV and the HCVcAg assay (Architect HCV Ag assay, Abbott, Hoofddorp,
assay, which is typically used to screen for virus exposure, followed the Netherlands). Medical records, including previous and follow-­up
by the more complex and expensive NAT to confirm viremia. laboratory tests, were retrospectively reviewed to identify cases
Chemiluminescent immunoassays (CLIAs) for anti-­HCV antibody with or without HCV infection. The testing sequence for these sam-
detection have been fully automated using high-­throughput, random ples is shown in Figure 1. The characteristics of the three automated
access instruments that are widely used as a screening tool for HCV anti-­HCV assays are shown in Table 1.
infection, particularly in high-­volume clinical laboratories. Recently, the
new Mindray anti-­HCV assay was developed for clinical laboratories.
2.3 | Seroconversion panels
It is a third-­generation immunoassay using antigens corresponding to
the HCV core, NS3, and NS4 proteins for the qualitative detection of Six HCV infection seroconversion panels were used to evaluate the
anti-­HCV antibodies in human serum or plasma. The aim of this study sensitivity of the Mindray anti-­HCV assay and Elecsys anti-­HCV II
was to evaluate its clinical diagnostic performance compared with that assays for early detection. These panels included PHV913, PHV915,
of the Architect anti-­HCV assay and Elecsys anti-­HCV II assay. PHV917, PHV920, PHV922, and PHV925 (Sera-­C are Life Sciences,
Milford, MA, USA).

2 | M ATE R I A L S A N D M E TH O DS
2.4 | Statistical analysis
2.1 | Subjects
Statistical analysis was carried out using SPSS statistical software ver-
This study included a total of 1952 cases from Peking University sion 16.0 (SPSS Inc., Chicago, IL, USA) and R package software. The
People’s Hospital. The median patient age was 58 years (range, 5 to sensitivity, specificity, positive and negative predictive values (PPV and
89 years), and 894 and 1058 patients were male and female, respec- NPV, respectively), and positive and negative likelihood ratios (LR+ and
tively. This study was approved by the ethics committee of Peking LR−, respectively) with 95% confidence intervals (CIs) were estimated
University People’s Hospital. by comparing the anti-­HCV antibody results of each anti-­HCV CLIA
assay with the diagnosis, that is, the presence or absence of HCV infec-
tion. The “DTComPair” test was used to perform a qualitative data com-
2.2 | Serological assays for HCV antibody detection
parison between each anti-­HCV CLIA assay. The correlation between
This prospective study was conducted in two stages. In the first stage, each anti-­HCV CLIA assay was evaluated using Pearson’s correlation
1860 consecutive unselected fresh serum samples, which were submit- test. The percentages of samples with S/CO ratios < 1.0, between 1.0
ted daily to the Department of Clinical Laboratory of Peking University and 10.0, and > 10.0 in each assay were evaluated using Kendall’s tau-­b
People’s Hospital for routine clinical testing, were analyzed using the statistic. A P-­value <.05 was considered significantly different.
Architect anti-­HCV assay on the Architect i2000 system (Abbott
Diagnostics, Wiesbaden, Germany). These samples were collected from
3 | R E S U LT S
October 2016 to December 2016. In the second stage, 92 serum samples
with reactive results from the Architect anti-­HCV assay were collected
3.1 | Sensitivity of the assays for the early detection
from May 2017 to July 2017. The collected serum samples were stored at
of HCV infection
−80°C prior to other testing. All of the 1952 samples were tested by the
Mindray anti-­HCV assay on the CL-­2000i analyzer (Mindray Diagnostics, Six HCV infection seroconversion panels were used, and the Mindray
Shenzhen, China) and by the Elecsys anti-­HCV II assay on the Cobas 601 anti-­HCV assay detected seroconversion in an average of 12.5 days
analyzer (Roche Diagnostics, Mannheim, Germany). (7, 12, 85, 13, 7, and 27 days), while the Elecsys anti-­HCV II assay
YUE et al. | 3 of 7

F I G U R E 1 HCV testing sequence for

clinical routine and preselected samples
with the Architect anti-­HCV assay
reactive results. S/CO = signal/cut-­off,
RIBA = recombinant immunoblot assay

TA B L E 1 Characteristics of the three

Reagent Elecsys anti-­HCV II Architect anti-­HCV Mindray anti-­HCV
automated anti-­HCV assays
Analyzer Cobas 601 Architect i2000 CL-­2000i
Manufacturer Roche Diagnostics Abbott Laboratories Mindray Bio-­Medical
Electronics Co., Ltd.
HCV antigen-­Core Present Present (HCr43) Present
HCV antigen-­NS3 Present Present (HCr43) Present
HCV antigen-­NS4 Present Present (c100-­3) Present
HCV antigen-­NS5 Absent Absent Absent
Method ECLIA CLIA CLIA
Solid phase Magnetic particle Paramagnetic particle Paramagnetic particle
Labeled substance Ruthenium complex Acridinium ester AMPPD
Sample vol (μL) 40 20 40
Time of reaction 18 29 39
(min)

detected seroconversion in average of 10.5 days (7, 5, 85, 13, 14, and further investigated by NAT for HCV RNA, the HCVcAg assay, and the
8 days) (Figure 2). There was no significant difference between the patient’s medical records. We observed one case with an HCV RNA-­
two assays (P = .818). positive result, two cases with an HCVcAg-­positive result, and one case
with a medical record of HCV infection, and these four cases indicated
HCV infection. The remaining 91 cases with HCV RNA-­ and HCVcAg-­
3.2 | Serological assays for HCV antibody detection
negative results indicated no HCV infection. In general, of the 1952
Of the 1952 enrolled samples, 1771 samples subjected to CLIAs were cases, 90 cases were categorized as HCV infection and 1862 cases
nonreactive in all three assays. These cases indicated no HCV infec- were categorized as no HCV infection.
tion. The remaining 181 samples were reactive according to at least
one anti-­HCV CLIA assay and were further tested with RIBA. Among
3.3 | Diagnostic performance of the three anti-­
these samples, 47.5% (86/181) were RIBA-­positive, 12.2% (22/181)
HCV assays
were RIBA-­indeterminate, and 40.3% (73/181) were RIBA-­negative.
Moreover, 86 cases with RIBA-­positive results had HCV infection. In The sensitivity, specificity, PPV, NPV, LR+ and LR-­ of each assay for
addition, 95 cases with indeterminate and negative RIBA results were the detection of HCV infection are listed in Table 2 as follows: the
4 of 7 | YUE et al.

FIGURE 2 Results of the six HCV seroconversion panels using two different anti-­HCV assays

Mindray anti-­HCV assay, 95.6%, 99.2%, 85.1%, 99.8%, 118.6 and Mindray anti-­HCV assay and Architect anti-­HCV assay (r = .916,
0.045, respectively; the Architect anti-­HCV assay, 98.9%, 95.2%, P < .001; Figure 3A). However, we found a significant but weak
50.0%, 99.9%, 20.69 and 0.012, respectively; and the Elecsys anti-­ positive correlation between the Mindray anti-­HCV assay and the
HCV II assay, 96.7%, 99.9%, 98.9%, 99.8%, 1799.9 and 0.033, respec- Elecsys anti-­HCV II assay (r = .364, P < .001; Figure 3B) and between
tively. The “DTComPair” test results are listed in Table 3 and Table 4. the Elecsys anti-­HCV II assay and the Architect assay (r = .430,
There were no significant differences in the sensitivity, NPV and LR-­ P < .001; Figure 3C). The distribution of the S/CO ratios for the 181
among the three assays (P > .05). There were significant differences samples associated with each anti-­HCV assay is shown in Figure 4.
in the specificity, PPV, and LR+ between the two assays (P < .001). The percentages of samples with an S/CO ratio<1.0, between 1.0
and 10.0, and >10.0 in each assay were as follows: the Mindray anti-­
HCV assay, 44.2% (80/181), 14.9% (27/181) and 40.9% (74/181),
3.4 | S/CO ratio analysis of the three anti-­
respectively; the Architect anti-­HCV assay, 1.7% (3/181), 60.7%
HCV assays
(110/181) and 37.6% (68/181), respectively; and the Elecsys anti-­
For the 181 samples with at least one anti-­HCV CLIA-­reactive re- HCV II assay, 51.4% (93/181), 1.1% (2/181) and 47.5% (86/181), re-
sult, the scatter diagrams of the S/CO ratios for each anti-­HCV assay spectively. There were significant differences in the distribution of
are shown in Figure 3. There was a good correlation between the the S/CO ratios between each pair of assays (P < .001).

TA B L E 2 Diagnostic performance of anti-­HCV assays for the detection of HCV infection (n = 1952)

HCV infection

NO. of
patients
Assay and %Sensitivity %Specificity PPV NPV LR+ LR−
results Yes No (95%CI) (95%CI) (95%CI) (95%CI) (95%CI) (95%CI)

Mindray
Reactive 86 15 95.6% 99.2% 85.1% 99.8% 118.6 0.045
Nonreactive 4 1847 (91.3%-­99.8%) (98.8%-­99.6%) (78.2%-­92.1%) (99.6%-­100.0%) (71.5-­196.7) (0.02-­0.12)

Architect
Reactive 89 89 98.9% 95.2% 50.0% 99.9% 20.69 0.012
Nonreactive 1 1773 (96.7%-­100.0%) (94.3%-­96.2%) (42.7%-­57.3%) (99.8%-­100.0%) (16.87-­25.37) (0.002-­0.082)

Elecsys
Reactive 87 1 96.7% 99.9% 98.9% 99.8% 1799.9 0.033
Nonreactive 3 1861 (93.0%-­100.0%) (99.8%-­100.0%) (96.6%-­100.0%) (99.7%-­100.0%) (253.6-­12775.9) (0.011-­0.101)

CI, confidence interval; LR−, negative likelihood ratio; LR+, positive likelihood ratio; NPV, negative predictive value; PPV, positive predictive value.
YUE et al. | 5 of 7

TA B L E 3 Sensitivity comparisons of the three anti-­HCV CLIA assays in patients with HCV infection (n = 90)

NO. of patients

Architect Elecsys Mindray DTCompair test

Assay and results Reactive Nonreactive Nonreactive Negative Reactive Nonreactive P value

Mindray
Reactive 85 4 .179
Nonreactive 1 0
Architect
Reactive 86 3 .317
Nonreactive 1 0
Elecsys
Reactive 86 1 .317
Nonreactive 0 3

TA B L E 4 Specificity comparisons of the three anti-­HCV antibody assays in patients with no evidence of HCV infection (n = 1862)

NO. of patients

Architect Elecsys Mindray DTComPair test

Assay and results Reactive Nonreactive Reactive Nonreactive Reactive Nonreactive P value

Mindray
Reactive 13 76 <.001
Nonreactive 2 1771
Architect
Reactive 1 88 <.001
Nonreactive 0 1773
Elecsys
Reactive 1 0 <.001
Nonreactive 14 1847

4 | D I S CU S S I O N specificity in other countries, including China.9 In the present study,

we used RIBA to analyze 181 samples with at least one anti-­HCV
Early detection of HCV antibody is important for the effective CLIA-­reactive result. Among these samples, 47.5% (86/181), 12.2%
screening and fast diagnosis of HCV infection, enabling infected pa- (22/181), and 40.3% (73/181) cases were positive, indeterminate, and
tients to be diagnosed and treated to prevent disease progression negative by RIBA, respectively. These results were consistent with
and viral spread. Previous studies have revealed that the Elecsys anti-­ those obtained in several previous studies.10,11 It can be difficult to
HCV II assay is more sensitive for early detection than the Architect interpret the significance of RIBA-­indeterminate results, as HCV RNA
anti-­HCV assay and other comparative assays.6,7 According to our is usually not detectable. The possibility that the cases were CIA re-
study, the Mindray anti-­HCV assay displayed a similar sensitivity to active but RIBA-­indeterminate or RIBA-­negative may be due to one of
the Elecsys anti-­HCV II assay with respect to the early detection of the following: (i) resolved HCV infection when the antibodies to some
HCV infection. HCV antigens are no longer detectable; (ii) early seroconversion when
Screening tests for the diagnosis of infectious diseases need to fluctuating RNA levels may become temporarily undetectable; (iii) oc-
have high sensitivities to detect all or nearly all affected individuals. cult HCV infection; or (iv) nonspecific reactivity. In our study, the NAT
Consequently, screening tests generally produce more false-­positive for HCV RNA, the HCVcAg assay, and medical records were used to
results and require good available supplemental tests. RIBA is labor-­ analyze the results for these cases to ensure the diagnostic accuracy
intensive and time-­consuming and is no longer recommended as a sup- and avoid false-­positive and false-­negative results.
plemental test for anti-­HCV confirmation in the 2013 CDC guidelines, Several studies have evaluated the currently available anti-­HCV
8
and only NAT is required. RIBA is still commonly used due to its high assays, with the sensitivity of each assay demonstrating variability
6 of 7 | YUE et al.

F I G U R E 3 Correlation of the S/CO ratios among the Mindray anti-­HCV, Architect anti-­HCV, and Elecsys anti-­HCV II assays (n = 181).
S/CO = signal/cut-­off

Mindray an -HCV Architect an - HCV Elecsys an - HCV

nega ve posi ve nega ve posi ve nega ve posi ve

3
4

67 90 85
76 74
47 3

23 2
3
9 11 3 22
1 1 22 01 30 12 12 2 11 5 1 1
0 10 10 10 0 0 10 0 0 0 0 0 0 0 10 0 0 10

F I G U R E 4 Distribution of S/CO ratios in 181 samples assayed using the Elecsys anti-­HCV II assay, Architect anti-­HCV assay and Mindray
anti-­HCV assay

from 61.0% to 100% and the specificity being high, ranging from the Mindray and Architect assays. Such discrepant results between
97.5% to 100%.6,7,12-14 In the present study, we evaluated the diag- immunoassays have been reported elsewhere.6 The reasons for this
nostic performance of the Mindray anti-­HCV assay for the detec- discrepancy may be attributed to the methods and molecules used
tion of HCV infection and showed a high sensitivity of 95.6% and to generate and detect the signals, as well as the differences in the
excellent specificity of 99.2%. The sensitivity, NPV and LR− were epitopes and specificities of the antigens and antibodies in the re-
similar to those of the Elecsys anti-­HCV II assay and Architect anti-­ agents between the assays.
HCV assay (P > .05). The specificity, PPV and LR+ of the Elecsys anti-­ CDC guidelines have recommended that the anti-­HCV threshold
HCV II assay were superior to those of the Mindray anti-­HCV assay S/CO ratio can be used to reduce the necessity for supplemental
(P < .001). The corresponding data from the Mindray anti-­HCV assay testing and may provide additional insight into a subject’s true anti-­
were superior to those from the Architect anti-­HCV assay (P < .001). HCV antibody status.17 Several previous studies have reported the
These results are consistent with those of several previous studies threshold S/CO ratio, which predicts positive results in ≥ 95% of
in which the diagnostic performance of the Elecsys anti-­HCV II assay supplemental tests for a variety of anti-­HCV assays.6,8,9,18 Among
7,15
was compared with that of the Architect anti-­HCV assay. the 181 samples with anti-­HCV CLIA-­positive results according to
The prevalence of HCV infection was reported to be 0.43% in at least one assay, the percentages of samples with an S/CO ratio
16
China. However, it was 4.6% in our study. The reason for discrepancy between 1.0 and 10.0 according to the Mindray anti-­HCV, Architect
may be due to the case selection bias in the present study. First, the anti-­HCV and Elecsys anti-­HCV II assays were 14.9% (27/181),
presence of anti-­HCV antibody was determined by a doctor. Second, 60.7% (110/181), and 1.1% (2/181), respectively. Thus, the Elecsys
some samples that yielded reactive results in the Architect Anti-­HCV anti-­HCV II assay and Mindray anti-­HCV assay have better signal-­to-­
assay were selected. Thus, the prevalence of HCV infection should be noise ratios for weakly reactive samples than the Architect anti-­HCV
considered in the evaluation of PPV and NPV according to our study. assay. Thus, these assays could reduce the necessity for supplemen-
The S/CO ratios of the Mindray anti-­HCV assay correlated well tal testing, and savings in cost and time could be achieved.
with those of the Architect anti-­HCV assay, showing a correlation This study has several limitations. First, NAT and HCVcAg on the
coefficient of .916, but they correlated weakly with those of the anti-­HCV CLIA nonreactive samples were not performed. Anti-­HCV
Elecsys anti-­HCV II assay. The Mindray and Architect anti-­HCV results could be persistently negative while HCV RNA is positive in
assays were based on the indirect principle. However, the Elecsys patients with chronic HCV infection, including those who have a
anti-­HCV II assay, an electrochemiluminescence assay, was based on compromised immune system. Second, this study included only 90
the double-­antigen sandwich principle. This finding may potentially cases with HCV infection. Further studies with larger sample sizes
explain why the best correlation was found between the results of are needed to confirm our findings.
YUE et al. | 7 of 7

In summary, the Mindray anti-­HCV assay shows a high diagnostic 9. Pan J, Li X, He G, et al. Reflex threshold of signal-­to-­cut-­off ratios of
performance, particularly in terms of high sensitivity, excellent speci- the Elecsys anti-­HCV II assay for hepatitis C virus infection. J Infect
Dev Ctries. 2016;10:1031‐1034.
ficity, and NPV, in the screening of routine clinical samples. However,
10. Kiely P, Styles C. Anti-­HCV immunoblot indeterminate results in
our data suggest that each anti-­HCV assay has limitations, including blood donors: non-­specific reactivity or past exposure to HCV? Vox
the potential for false-­positive and false-­negative results. Therefore, Sang. 2017;112:542‐548.
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to-­cut-­off ratios from three automated anti-­hepatitis C virus
should be analyzed with a second test (e.g., HCVcAg, NAT).
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binant immunoblot assays and nucleic acid testing. Blood Transfus.
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