Performance of the OraQuick HCV Rapid Antibody Test for Screening Exposed Patients in a Hepatitis C Outbreak Investigation

Gao, Fei; Talbot, Elizabeth A.; Loring, Carol; Power, J; Dionne-Odom, Jodie; Alroy‐Preis, Sharon; Jackson, Patricia L.; Bean, Christine

doi:10.1128/jcm.00132-14

Cited by 26 publications

(16 citation statements)

References 5 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…1 ) [ 8 , 16 , 19 – 68 ]. Of the 52 studies, 32 studies evaluated the accuracy of 30 different rapid diagnostic tests (RDTs) [ 19 – 50 ], of which 5 evaluated RDTs compared to EIA alone [ 25 , 26 , 31 , 34 , 49 ], 13 compared RDT results to NAT or immunoblot [ 19 – 22 , 27 , 29 , 32 , 37 , 42 , 43 , 45 , 47 , 50 ], and 14 focused on evaluating RDT by comparing with the results of EIA or immunoblot or NAT [ 23 – 26 , 30 , 34 , 35 , 38 , 39 , 41 , 44 , 48 , 49 , 51 ]. Eleven studies evaluated the diagnostic accuracy of oral fluid RDTs [ 22 , 24 , 27 , 29 , 33 , 34 , 43 – 45 , 47 , 52 ].…”

Section: Resultsmentioning

confidence: 99%

Diagnostic accuracy of tests to detect Hepatitis C antibody: a meta-analysis and review of the literature

et al. 2017

View full text Add to dashboard Cite

Background: Although direct-acting antivirals can achieve sustained virological response rates greater than 90% in Hepatitis C Virus (HCV) infected persons, at present the majority of HCV-infected individuals remain undiagnosed and therefore untreated. While there are a wide range of HCV serological tests available, there is a lack of formal assessment of their diagnostic performance. We undertook a systematic review and meta-analysis to evaluate he diagnostic accuracy of available rapid diagnostic tests (RDT) and laboratory based EIA assays in detecting antibodies to HCV. Methods: We used the PRISMA checklist and Cochrane guidance to develop our search protocol. The search strategy was registered in PROSPERO (CRD42015023567). The search focused on hepatitis C, diagnostic tests, and diagnostic accuracy within eight databases (MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, Science Citation Index Expanded, Conference Proceedings Citation Index-Science, SCOPUS, Literatura Latino-Americana e do Caribe em Ciências da Saúde and WHO Global Index Medicus. Studies were included if they evaluated an assay to determine the sensitivity and specificity of HCV antibody (HCV Ab) in humans. Two reviewers independently extracted data and performed a quality assessment of the studies using the QUADAS tool. We pooled test estimates using the DerSimonian-Laird method, by using the software R and RevMan. 5.3. Results: A total of 52 studies were identified that included 52,673 unique test measurements. Based on five studies, the pooled sensitivity and specificity of HCV Ab rapid diagnostic tests (RDTs) were 98% (95% CI 98-100%) and 100% (95% CI 100-100%) compared to an enzyme immunoassay (EIA) reference standard. High HCV Ab RDTs sensitivity and specificity were observed across screening populations (general population, high risk populations, and hospital patients) using different reference standards (EIA, nucleic acid testing, immunoblot). There were insufficient studies to undertake subanalyses based on HIV co-infection. Oral HCV Ab RDTs also had excellent sensitivity and specificity compared to blood reference tests, respectively at 94% (95% CI 93-96%) and 100% (95% CI 100-100%). Among studies that assessed individual oral RDTs, the eight studies revealed that OraQuick ADVANCE® had a slightly higher sensitivity (98%, 95% CI 97-98%) compared to the other oral brands (pooled sensitivity: 88%, 95% CI 84-92%). Conclusions: RDTs, including oral tests, have excellent sensitivity and specificity compared to laboratory-based methods for HCV antibody detection across a wide range of settings. Oral HCV Ab RDTs had good sensitivity and specificity compared to blood reference standards.

show abstract

Section: Resultsmentioning

confidence: 99%

Diagnostic accuracy of tests to detect Hepatitis C antibody: a meta-analysis and review of the literature

et al. 2017

View full text Add to dashboard Cite

show abstract

“…NAT (Two Tubes) strategy was operationally the most expedient for testing exposed patients, given the need to test a large population urgently and the ready access to viremia testing. 28 One limitation to the analysis presented here is that national median charges for HCVAb and NAT reported in the CMS' Clinical Laboratory Fee Schedule 21 were the basis of cost comparison. These charges made by individual health care providers or laboratories vary for many reasons, including variation in the amount they pay for the assay and variation in the cost of labor.…”

Section: Discussionmentioning

confidence: 99%

“…Another test population comprises persons notified to participate in look‐back investigations of outbreaks. During the nosocomial hepatitis C outbreak in New Hampshire in 2012, the OraQuick HCVAb (Venipuncture) → NAT (Two Tubes) strategy was operationally the most expedient for testing exposed patients, given the need to test a large population urgently and the ready access to viremia testing …”

Section: Discussionmentioning

confidence: 99%

Cost‐effectiveness of strategies for testing current hepatitis C virus infection

Chapko

Hatia²,

Drobeniuc³

et al. 2015

Hepatology

View full text Add to dashboard Cite

Six strategies for identifying hepatitis C virus (HCV) viremia, involving testing for HCV antibody (HCVAb) followed by a nucleic acid test (NAT) for HCV RNA when the antibody test is positive, are compared. Decision analysis was used to determine mean relative cost per person tested and outcomes of HCV viremia detection. Parameters included proportions of test population with HCVAb and viremia plus specificity, sensitivity, and cost of individual tests. For testing a population with an HCVAb seroprevalence of 3.25%, all strategies when adopting quantitative NAT vary little in cost (range, $29.50-$30.70) and are highly viremia specific ( 0.9997). Four of the strategies using venipuncture blood for HCVAb testing (whether laboratory conducted or employing a rapid, point-of-care assay) and for NAT (whether done by reflex or using separately drawn blood) achieve the highest viremia sensitivities (range, 0.9950-0.9954). Point-of-care HCVAb testing in fingerstick blood followed by NAT in venipuncture blood yields relatively lower viremia sensitivity (0.9301). The strategy that requires returning for NAT is even less viremia sensitive (<0.9000) because of follow-up loss. Strategies adopting qualitative rather than quantitative NAT are slightly cheaper (range, $28.90-$29.99), similarly viremia specific ( 0.9997), but less viremia sensitive ( £ 0.9456). Viremia sensitivity and specificity remain the same regardless of the proportion of HCVAb-seropositive persons in the cohort being tested. Conclusions: Strategies involving HCVAb testing in venipuncture blood, whether laboratory conducted or using a point-of-care assay, when followed by quantitative NAT done reflexively or in separately drawn blood, are comparably economical and suitably viremia sensitive. Less cost-effective is point-of-care HCVAb testing in fingerstick blood followed by NAT in venipuncture blood. Least cost-effective is the strategy requiring the tested person to return for NAT. (HEPATOLOGY 2015;62:1396-1404

show abstract

“…The total number of patient notifications from those U.S. outbreaks was at least 20,000, considering additional notifications from investigations launched by health care facilities that were not outbreak sites, but had previously employed the transmitter providers . The health burdens generated by HCV transmissions associated with opioid tampering, together with the resources directed to providing counseling and care to infected patients and their contacts, are considerable, as are resources expended by infection control, community health, law enforcement, and judiciary agencies …”

Section: Discussionmentioning

confidence: 99%

Nosocomial hepatitis C virus transmission from tampering with injectable anesthetic opioids

Hatia¹,

Dimitrova²,

Skums³

et al. 2015

Hepatology

View full text Add to dashboard Cite

The extent of provider-to-patient hepatitis C virus (HCV) transmission from diversion, self-injection, and substitution ("tampering") of anesthetic opioids is unknown. To quantify the contribution of opioid tampering to nosocomial HCV outbreaks, data from health care-related HCV outbreaks occurring in developed countries from 1990 to 2012 were collated, grouped, and compared. Tampering was associated with 17% (8 of 46) of outbreaks, but 53% (438 of 833) of cases. Of the tampering outbreaks, six (75%) involved fentanyl, five (63%) occurred in the United States, and one each in Australia, Israel, and Spain. Case counts ranged from 5 to 275 in the tampering outbreaks (mean, 54.8; median, 25), and 1-99 in the nontampering outbreaks (mean, 10.4; median, 5); between them, the difference in mean ranks of counts was significant (P < 0.01). To estimate HCV transmission risks from tampering, risk-assessment models were constructed, and these risks compared with those from surgery. HCV transmission risk from exposure to an opioid preparation tampered by a provider of unknown HCV infection status who is a person who injects drugs (PWID; 0.62%; standard error [SE] 5 0.38%) exceeds 16,757 times the risk from surgery by a surgeon of unknown HCV infection status (0.000037%; SE 5 0.000029%) and 135 times by an HCV-infected surgeon (0.0046%; SE 5 0.0033%). To pose a 50% patient transmission risk, an infected surgeon may take 30 years, compared to <1 year for a PWID tamperer, and weeks or days for a PWID tamperer who intensifies access to opioids. Conclusion: Disproportionately, many cases of HCV infection from nosocomial outbreaks were attributable to provider tampering of anesthetic opioids. Transmission risk from tampering is substantially higher than from surgery. (HEPATOLOGY 2015;62:101-110)

show abstract

Performance of the OraQuick HCV Rapid Antibody Test for Screening Exposed Patients in a Hepatitis C Outbreak Investigation

Cited by 26 publications

References 5 publications

Diagnostic accuracy of tests to detect Hepatitis C antibody: a meta-analysis and review of the literature

Diagnostic accuracy of tests to detect Hepatitis C antibody: a meta-analysis and review of the literature

Cost‐effectiveness of strategies for testing current hepatitis C virus infection

Nosocomial hepatitis C virus transmission from tampering with injectable anesthetic opioids

Contact Info

Product

Resources

About