Abstract
Background:
Rapid point-of-care tests for hepatitis C virus (HCV) provide results in 20 minutes and allow linkage to care, particularly for difficult-to-reach populations. Prior work suggested an early reading time of the OraQuick® (OQ) rapid HCV antibody lateral flow immunoassay identified people with HCV viremia; however, these observations were not externally validated.
Methods:
We conducted a prospective cohort study at Penn Presbyterian Medical Center from June 2021-August 2023 to evaluate the performance of OQ early reading times for HCV viremia among participants with reactive HCV antibody. Following test device insertion for whole blood substrate, the OQ assay was evaluated every minute from 5-10 minutes, then at 20 and 40 minutes. Early read time performance was evaluated against the standard-of-care HCV RNA.
Results:
175 participants (120 [68.6%] with detectable HCV viremia) completed the OQ assay. Among HCV viremic participants, 119 had a positive whole blood OQ by 7 minutes (sensitivity: 99.2% [95% confidence interval, CI: 95.4-100]; positive predictive value: 82.1% [95% CI: 74.8-87.9]); 1 viremic participant with severe immunosuppression was not identified at this early reading time. No time interval accurately identified only those with HCV viremia, yet a negative OQ test at 7 minutes excluded HCV viremia (negative predictive value: 96.3% [95% CI: 81.0-99.9]).
Discussion:
A 7-minute reading time for a whole blood OQ assay may reduce the need for HCV RNA testing and improve screening efficiency by identifying people without HCV viremia. Early read time results cannot be used to exclusively identify HCV viremia and should be used with caution in those with severe immunosuppression or if acute HCV infection is suspected.
Keywords: Hepatitis C virus, HCV testing, hepatitis C viremia, HCV antibody lateral flow immunoassay
INTRODUCTION
Increased access to screening strategies is critically important to achieve the World Health Organization’s 2030 goal of hepatitis C virus (HCV) elimination [1]. Point-of-care (POC) testing for HCV is an important screening strategy that can enable rapid identification of people in need of antiviral treatment and could facilitate timely linkage to care, including in settings outside of conventional healthcare environments [2]. POC HCV testing can additionally reduce barriers to care, particularly among people at highest risk of HCV infection [3].
The recent approval of the Cepheid Xpert POC HCV RNA assay has provided a much-needed tool to support a test-and-treat approach, offering a rapid and accurate solution to identifying HCV viremia [4]. However, implementation of this platform may be limited by screening costs, testing volume, and logistical challenges that may preclude use in de-centralized settings [5, 6]. Thus, additional POC approaches are needed to accurately distinguish people with and without HCV viremia.
Identification of anti-HCV antibodies via POC testing has been available for 15 years with the OraQuick® rapid HCV antibody lateral flow immunoassay (OQ), which can detect anti-HCV antibodies in blood within 20 minutes [7]. This Clinical Laboratory Improvement Amendments-waived testing platform can allow for large community-based screenings, yet a positive assay still requires RNA confirmation. Prior work has indicated that an early reading time for the OQ assay can accurately identify people with and without viremia.[8] While that study identified all participants with HCV viremia who had positive whole blood OQ assay at 5 minutes [8], these observations have not been externally validated.
In this study, we evaluated the performance characteristics of early reading times of the OQ assay for identification of HCV viremia. Confirming such a time-point to accurately rule-in or rule-out detectable HCV viremia would support expansion of such rapid testing platforms for improved effectiveness of high throughput HCV screening, diagnosis, and linkage to treatment.
MATERIALS AND METHODS
Study Design and Setting
We conducted a prospective cohort study of participants with reactive HCV antibody who were recruited from the outpatient infectious diseases/viral hepatitis practice and inpatient wards of the Penn Presbyterian Medical Center in Philadelphia, Pennsylvania. Patients were identified from inpatient HCV screening or outpatient HCV-related longitudinal clinical care and enrolled between June 18, 2022 and August 31, 2023.
Participants recruited from the inpatient setting were identified through an HCV screening and linkage program. Prior to the study period, the hospital launched a default inpatient HCV screening program for patients born between 1945-1965 [9]. Briefly, patients admitted to the hospital for any reason who had not previously completed HCV screening within the health system had an HCV antibody with reflex to confirmatory PCR assay embedded within the admission order set. The laboratory test was defaulted to order with collection scheduled for the next routine morning draw. Providers could opt-out of HCV screening if deemed not clinically warranted. The results of HCV screening completed as part of the default inpatient HCV screening program were automatically routed to the HCV Linkage Team for proactive result disclosure, HCV counseling, and linkage to care if HCV viremia was noted. Patients of any birth year screened for HCV outside of this default admission order set could be referred to the HCV Linkage Team by the inpatient provider. All hospitalized patients seen by the HCV Linkage Team were eligible for study enrollment. Eligible patients were approached by the study team following HCV counseling delivered by the HCV Linkage Team.
Patients engaged in care at the outpatient infectious diseases/viral hepatitis practice were also eligible for enrollment. This outpatient practice provided evaluation, treatment, and post-HCV longitudinal care for adults with chronic HCV infection, regardless of HIV coinfection status. Patients presenting to this ambulatory setting were referred from community providers or following hospitalization. Patients were approached for enrollment at the conclusion of their clinical visit by a study team member.
Study Participants
Patients were eligible for enrollment if they were: 1) ≥18 years of age, 2) English-speaking, and 3) either previously diagnosed with chronic HCV infection or had a reactive HCV antibody assay within their electronic health record. The reference standard for determination of a reactive HCV antibody was completed through routine clinical testing using an enzyme immunoassay (EIA) for qualitative detection of antibodies to HCV in serum. Patient samples with a reactive screening test for HCV antibodies underwent reflexive real-time PCR for quantitative assessment of HCV RNA. All participants who provided written informed consent were included in the study. Since the OQ screening platform was developed and approved for use in people with chronic HCV infection, participants whose presentation was consistent with acute HCV infection were excluded. Participants were enrolled following disclosure of reactive HCV antibody result by the HCV Linkage Team or outpatient provider; confirmatory HCV RNA results were either available or in process at the time of enrollment to ensure availability of a reference standard comparator. Study team members were not blinded to HCV RNA results. No clinical decisions were made based on results of the OQ test.
Sample Collection
A whole blood sample via finger stick and oral mucosal transudate (OMT) sample via buccal mucosa swab were collected from each participant for evaluation by the OQ testing platforms. Five microliters of whole blood were obtained via standard lancing device applied to the participant’s finger, collected with the included specimen collection loop, and immediately added to the OQ sample developer solution. The OQ test device was then inserted into the developer solution vial within 60 minutes following inoculation with the whole blood sample (as per the product monograph) [7]. The whole blood test result was evaluated first at five minutes following test device insertion and then at every subsequent minute up to and including 10 minutes following test device insertion. Final readings at 20 and 40 minutes (the standard read-time interval for the assay) concluded the test device evaluation. At each time point, the study team indicated whether the test was visually positive or negative per the manufacturer’s guidelines. Photographs of the test device at each read time were collected for verification. Time to positivity was defined based on real-time evaluation of the band at the whole minute reading time.
The OMT sample was collected by participants swabbing their upper and lower gums with the flat pad attached to the OQ test device and immediately adding it to the developer solution. The OMT test result was evaluated at 20 minutes and again at 40 minutes following inoculation into the testing solution. At each time point, the study team indicated if the test was visually positive or negative, and photographs of the test device were collected at both time points.
Data Collection
Participant demographic, clinical, and laboratory characteristics were collected from their electronic medical records. Data included: age at study enrollment, gender, prior HCV diagnosis, history of HCV treatment (defined by patient report or dispensed prescription of direct-acting antivirals and/or interferon-based therapy) and outcome (cure or treatment failure), patient-reported diagnosis or prior imaging findings consistent with cirrhosis, and HIV status. Participants with documentation of HCV cure within three years of study enrollment date were classified as recent sustained virologic response (SVR), and those with documented HCV cure three or more years prior to enrollment were classified as long-term SVR. Participants were classified as having spontaneous HCV clearance if they were HCV antibody-positive but HCV RNA-negative without known treatment. Laboratory results for hepatitis B virus surface antigen (HBsAg), alanine aminotransferase, aspartate aminotransferase, and platelet count were collected. If more than one laboratory result was available, the result closest to the enrollment date was selected. The Fibrosis-4 Index for Hepatic Fibrosis (FIB-4), a non-invasive measure of hepatic fibrosis, was calculated by: (age [years] x aspartate aminotransferase [U/L])/(platelet count [109/L]) x (alanine aminotransferase [U/L])1/2) [10].
Statistical Analysis
We first determined the performance characteristics, with 95% confidence intervals (CIs), of the OQ whole blood assay compared to the reflexive quantitative HCV RNA run as standard of care. We calculated the assay sensitivity (i.e., ability of a positive OQ assay to correctly identify those who have HCV viremia), specificity (i.e., ability of OQ to correctly identify those who do not have HCV viremia), positive predictive value (i.e., proportion with positive OQ assay confirmed to have detectable HCV viremia by HCV PCR), and negative predictive value (i.e., proportion without a positive OQ assay who do not have HCV viremia by HCV PCR) [11]. We aimed to identify the earliest time at which HCV viremia could be excluded by the OQ assay. We focused on maximizing negative predictive value to correctly identify individuals who did not have HCV viremia. A high negative predictive value will reassure patients and clinicians that a negative test result means viremia is likely absent, making further confirmatory testing unnecessary.
We additionally determined the performance characteristics, with 95% CIs, of the OQ OMT assay compared to the reflexive quantitative HCV RNA, Since OMT is not a currently approved substrate for POC HCV RNA screening in the United States, this secondary analysis evaluated the sensitivity, specificity, positive predictive value, and negative predictive value of the OQ OMT assay at 20 minutes and 40 minutes for identification of HCV viremia.
Statistical analyses were performed using Stata 14.1 (College Station, TX). All authors had access to the study data and reviewed and approved the final manuscript.
Ethics
All participants provided written informed consent, and the protocol was approved by the Institutional Review Board of the University of Pennsylvania. All research was conducted in accordance with the Declaration of Helsinki.
Role of the Funding Source
The study was funded in part by discretionary resources provided by the investigators and by National Institute of Diabetes and Digestive and Kidney Diseases (K08DK132977; JT). Participant enrollment, data collection, analysis, interpretation of the data, writing the report, and the decision to publish were at the sole discretion of the investigators. Testing kits were purchased by the investigators from OraSure at commercial cost.
RESULTS
One hundred and eighty-four participants were enrolled in this study, with 175 participants eligible for inclusion in the analysis (Figure 1). Overall, 69 (39.4%) participants were 50-64 years of age, 123 (70.3%) were male, 35 (20.0%) had cirrhosis, 3 (1.7%) were hepatitis B surface antigen-positive and 38 (21.7%) had HIV infection (Table 1). Thirty-six participants (20.6%) reported prior use of direct-acting antiviral therapy for chronic HCV infection, and 9 (5.1%) reported prior use of interferon-based treatment.
Figure 1. Participant Enrollment for Validation of OraQuick Whole Blood and Oral Mucosal Transudate Assays.
Abbreviations: HCV, hepatitis C virus; OMT, oral mucosal transudate; WB, whole blood
Table 1. Participant Characteristics by Status of HCV Viremia.
| Characteristic | Total (n=175) |
Viremic (n=120) |
Recent SVR (<3 years) (n=8) |
Long-Term SVR (≥3 years) (n=26) |
Spontaneous Clearance† (n=21) |
|---|---|---|---|---|---|
| Male sex, n (%) | 123 (70.3%) | 77 (64.2%) | 7 (87.5%) | 23 (88.5%) | 16 (76.2%) |
| Age (years) | |||||
| 18-29 | 10 (5.7%) | 9 (7.5%) | -- | -- | 1 (4.8%) |
| 30-49 | 45 (25.7%) | 33 (27.5%) | 2 (25%) | 4 (15.4%) | 6 (28.6%) |
| 50-64 | 69 (39.4%) | 54 (37.5%) | 3 (37.5%) | 13 (50.0%) | 8 (38.1%) |
| ≥65 | 51 (29.1%) | 33 (27.5%) | 3 (37.5%) | 9 (34.6%) | 6 (28.6%) |
| Cirrhosis ‡ | 35 (20.0%) | 23 (19.2%) | 2 (25%) | 9 (34.6%) | 1 (4.8%) |
| FIB-4 score, n (%) | |||||
| <1.45 | 87 (49.7%) | 63 (52.5%) | 3 (37.5%) | 12 (46.2%) | 9 (42.9%) |
| 1.45-3.25 | 62 (35.4%) | 41 (34.2%) | 4 (50.0%) | 8 (30.8%) | 9 (42.9%) |
| >3.25 | 19 (10.9%) | 12 (10%) | 1 (12.5%) | 5 (19.2%) | 1 (4.8%) |
| Missing | 7 (4.0%) | 4 (3.3%) | -- | 1 (3.8%) | 2 (9.5%) |
| HCV RNA log10 IU/mL, median (IQR) | -- | 6.15 (5.46, 6.57) | -- | -- | -- |
| HCV genotype | |||||
| 1 | -- | 62 (51.7%) | -- | -- | -- |
| 2 | -- | 3 (2.5%) | -- | -- | -- |
| 3 | -- | 5 (4.2%) | -- | -- | -- |
| Unknown | -- | 50 (41.7%) | -- | -- | -- |
| Reactive HBsAg | 3 (1.7%) | 2 (1.7%) | 0 | 0 | 1 (4.8%) |
| Unknown | 25 (14.3%) | 14 (11.7%) | 0 | 2 (11.5%) | 8 (38.1%) |
| HIV infection | 38 (21.7%) | 8 (6.7%) | 3 (37.5%) | 19 (73.1%) | 8 (38.1%) |
| Unknown | 15 (8.6%) | 8 (6.7%) | 0 | 2 (7.7%) | 5 (23.8%) |
| HCV treatment § | |||||
| Pegylated interferon | 9 (5.1%) | 3 (2.5%) | 1 (12.5%) | 5 (19.2%) | -- |
| Direct-acting antiviral | 36 (20.6%) | 9 (7.5%) | 8 (100%) | 19 (73.1%) | -- |
Abbreviations: FIB-4, Fibrosis-4 Index for Hepatic Fibrosis; HBsAg, hepatitis B surface antigen; HCV, hepatitis C virus; HIV, human immunodeficiency virus; SVR, sustained virologic response
Includes patients with unknown/uncertain HCV treatment history
Defined as patient-reported diagnosis or prior imaging findings consistent cirrhosis
Not mutually exclusive
A total of 120 (68.6%) participants had quantifiable HCV viremia, 8 (4.6%) had recent SVR within three years of study enrollment, 26 (14.9%) had long-term SVR ≥3 years prior to enrollment, and 21 (17.5%) had prior spontaneous HCV clearance (Table 1). Of the 120 participants with HCV viremia, the median HCV RNA was 6.2 log10 IU/mL (interquartile range: 5.5-6.6 log10 IU/mL). HCV genotype results were available for 70 (58.3%) participants, with 62/70 (88.6%) identified as genotype 1.
Among HCV viremic participants, 116/120 (96.7%) had a positive OQ by 5 minutes, and 119 (99.2%) had a positive result by 7 minutes (Table 2). In contrast, 21/52 (40.4%; p<0.001) and 26/52 (50%; p<0.001) of HCV non-viremic participants had a positive OQ by 5 and 7 minutes, respectively (Figure 2). Among participants with a positive OQ, there was no time threshold that accurately differentiated participants with and without HCV viremia. Three participants with HCV viremia had a positive OQ assay between 5 and 7 minutes. The ages of the three participants ranged from 54-65 years. Two of the three were female, one participant had HIV and chronic HBV, and all three participants had cirrhosis. The HCV viral load for the three participants ranged from 6.3 and 6.8 log10 IU/mL.
Table 2. Performance of Whole Blood OraQuick® Rapid HCV Antibody Assay for Identification of HCV Viremia at Specified Incubation Times.
| Positive OraQuick® assay |
Negative OraQuick® assay |
Performance Characteristics | ||||||
|---|---|---|---|---|---|---|---|---|
| Time of assay |
HCV viremia |
No HCV viremia |
HCV viremia |
No HCV viremia |
Sensitivity (95% CI) |
Specificity (95% CI) |
PPV (95% CI) |
NPV (99% CI) |
| 5 min | 116 | 21 | 4 | 31 | 96.7 % (91.7, 99.1) |
59.6% (45.1, 73.0) |
84.7% (77.5, 90.3) |
88.6% (73.3, 96.8) |
| 6 min | 1 | 3 | 3 | 28 | 97.5% (92.9, 99.5) |
53.8% (39.5, 67.8) |
83.0% (75.7, 88.8) |
90.3% (74.2, 98.0) |
| 7 min | 2 | 2 | 1 | 26 | 99.2% (95.4, 100) |
50.0% (35.8, 64.2) |
82.1% (74.8, 87.9) |
96.3% (81.0, 99.9) |
| 8 min | 0 | 1 | 1 | 25 | 99.2% (95.4, 100) |
48.1% (34.0, 62.4) |
81.5% (74.2, 87.4) |
96.2% (80.4, 99.9) |
| 9 min | 0 | 1 | 1 | 24 | 99.2% (95.4, 100) |
46.2% (32.2, 60.5) |
81.0% (73.7, 87.0) |
96.0% (79.7, 99.9) |
| 10 min | 0 | 3 | 1 | 21 | 99.2% (95.4, 100) |
40.4% (27.0, 54.9) |
79.3% (72.0, 85.5) |
95.5% (77.2, 99.9) |
| 20 min | 1 | 8 | 0 | 13 | 100% (97.0, 100) |
25.0% (14.0, 38.9) |
75.5% (68.0, 81.9) |
100% (75.3, 100) |
| 40 min | 0 | 0 | 0 | 13 | 100% (97.0, 100) |
25.0% (14.0, 38.9) |
75.5% (68.0, 81.9) |
100% (75.3, 100) |
Abbreviations: CI, confidence interval; HCV, hepatitis C virus; NPV, negative predictive value; PPV, positive predictive value.
Figure 2. Kaplan Meier Curve of Time to Test Positivity for Whole Blood OraQuick, by HCV Viremia Status.
Among the 27 participants with a negative OQ at 7 minutes, 26 (96.3%) were HCV non-viremic. A single participant with HCV viremia and profound immunosuppression due to uncontrolled HIV (CD4+ T lymphocyte count: <35 cells/μL) was not identified by OQ by 7 minutes but ultimately identified by a positive OQ whole blood assay at 20 minutes of incubation. After excluding this immunosuppressed participant from the analysis, both the sensitivity and negative predictive value of the OQ by 7 minutes improved to 100% (Supplemental Table 1).
OMT OQ assay results were available for 174 participants, including 119 (68.4%) with HCV viremia. The negative predictive value of the OMT OQ assay was maximized at 40 minutes of incubation, with 100% of viremic participants identified by a positive assay (Supplemental Table 2). Similar to the whole blood assay, there was no time threshold that classified participants with and without HCV viremia with 100% accuracy.
DISCUSSION
We evaluated the performance characteristics of an early reading time for the OQ rapid antibody assay for identification of HCV viremia. Among 120 participants with viremia, 99.2% were identified with a positive OQ whole blood assay at 7 minutes. After excluding a single patient with HCV viremia and profound immunosuppression due to uncontrolled HIV, 100% of participants with viremia were identified by the whole blood OQ assay at 7 minutes of incubation. Our results suggest that a negative OQ whole blood assay can reliably exclude chronic HCV viremia among people without profound immunosuppression at this early reading time.
The use of an early reading time for the OQ rapid HCV antibody test has the potential to improve widespread, de-centralized testing, a key pillar of HCV elimination.[12] Application of this assay to exclude HCV viremia in 7 minutes could expand the utility of the test in high-risk populations and streamline screening with improved efficiency, but this testing approach would necessitate close monitoring by trained staff to evaluate the whole blood OQ assay at precisely the 7-minute mark to accurately differentiate negative and positive assays for optimal efficiency. Consideration for this time-sensitive assessment would be needed when developing workflows to incorporate this testing strategy within de-centralized service delivery settings. However, use of this testing platform to rule out HCV viremia could reduce the need for more costly confirmatory HCV RNA testing. Moreover, this approach can decrease the need for dedicated phlebotomy, of particular importance in people who inject drugs where challenging venous access can result in significant testing delays [12].
Despite the high sensitivity and negative predictive value of the 7-minute early reading time, the use of this assay to “rule in” viremia, particularly for a point of care test-and-treat approach, is unlikely to be a valuable strategy. While nearly all viremic participants had a positive OQ whole blood assay at 7 minutes, 50% of those without viremia were also positive at this time point. Given the lower specificity of this assay, use of the 7-minute threshold to initiate HCV treatment would result in unnecessary treatment of people without viremia.
Our study had several potential limitations. First the prevalence of HCV viremia observed was 68.6% and may be greater than that of the general population. Prior studies have suggested prevalence of viremia in noninstitutionalized populations is 45% [13]. As a result, the PPV of the early reading time OQ assay observed in our study may be higher than that for a sample with a lower prevalence of HCV viremia. However, in settings with a lower prevalence of disease, the NPV of a test would increase, reinforcing the utility of this assay to reliably exclude HCV viremia. Moreover, populations at higher risk for HCV (i.e., people in carceral settings [14] and people who inject drugs) have a prevalence of HCV viremia similar to our study. Given the potential benefit of this POC test for de-centralized screenings, our findings are likely generalizable to people at greatest risk for HCV viremia. Second, we excluded participants with findings consistent with acute HCV infection, since the OQ immunoassay is dependent upon detection of antibodies. Because HCV antibodies require 8-11 weeks to develop following exposure, the OQ assay is not suited as a screening test for acute HCV infection [15]. Third, we encountered OQ test platform errors resulting in the exclusion of participants from the analyses. While these errors occurred in <3% of assays completed and are unlikely to significantly bias our results, strict adherence to the manufacturer’s guidance on the test device inoculation and confirmation of control band are needed to ensure accuracy of this testing strategy in any setting.
CONCLUSION
Our study demonstrated that a negative whole blood OQ assay at 7 minutes reliably excludes HCV viremia, which may reduce the need for confirmatory HCV RNA testing and improve HCV screening efficiency. Early reading time results cannot be used to exclusively identify viremia and should especially be used with caution in those with severe immunosuppression or with suspected acute HCV infection.
Supplementary Material
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