scholarly journals Validation of OraQuick HCV Rapid Antibody Test in Postmortem Specimens

2020 ◽  
Vol 10 (2) ◽  
pp. 81-86
Author(s):  
Claire E. Rose ◽  
Lisa Duncan ◽  
Amy M. Hawes

INTRODUCTION: The objective of this study is to evaluate the performance of OraQuick HCV Rapid Antibody Test against a “gold-standard”, FDA-approved, laboratory-based serum immunoassay (SI) in postmortem blood. To date, OraQuick HCV Rapid Antibody Test has not been evaluated for use in postmortem testing. This OraQuick test is a manually performed, visually interpreted, single use immunoassay for the qualitative detection of antibodies to the hepatitis C virus (HCV). METHODS: Blood was collected from 51 decedents whose deaths were investigated in the jurisdiction of the Knox and Anderson County Medical Examiner’s Office (MEO) January 2017 through April 2017. For each consented case, blood was tested using both the OraQuick HCV Rapid Antibody Test and a laboratory-based hepatitis C serum immunoassay (“gold standard” reference assay). Results from the OraQuick HCV Rapid Antibody Test were compared against a laboratory-based hepatitis C serum immunoassay. RESULTS: Using the laboratory-based serum immunoassay (SI) as the “gold standard” for assessing true HCV antibody positivity, and comparing SI against OraQuick rapid test, sensitivity for the OraQuick rapid test was 95.65% and specificity was 96.15% in postmortem blood. DISCUSSION: Our results demonstrate that OraQuick HCV rapid antibody test is reliable for diagnosis of hepatitis C infection in postmortem blood with a relatively short (less than approximately 21.5 hours) postmortem sample acquisition time. The OraQuick in some cases may be superior to traditional, laboratory-based HCV SI due to potential increased viscosity of postmortem blood.

Author(s):  
Ranti Permatasari ◽  
Aryati Aryati ◽  
Budi Arifah

Hepatitis C (HCV) infection could be spread by blood transfusion. Screening of HCV in donor blood could prevent HCV infection to the recipient. HCV antibody test using rapid test of multiple antibody detection by immunochromatography method is an easy and rapid test that could detect four HCV antibodies separately. The aim of this study was to evaluate the diagnostic value of antibody HCV using multiple antibody detection rapid test in diagnosing HCV infection. This was an analytical observational study with a cross sectional design. The samples consisted of 42 donors’ blood serum from the Surabaya Branch of the Indonesian Red Cross which underwent HCV infection test using ELISA method. The samples were then tested using PCR HCV RNA as the gold standard and antibody HCV multiple antibodydetection rapid test The diagnostic value of HCV antibody test using multiple antibody detection rapid test by immunochromatography method showed a diagnostic sensitivity of 100%, diagnostic specificity of 75%, positive predictive value of 66.7% and negative predictive value of 100%, a diagnostic efficiency of 83.3%, with a positive probability ratio of 4 times. The most often positive antibody pattern was four (4) positive antibodies (core protein, NS3, NS4 and NS5). Core protein (CP) and NS3 were the most often positive antibodies. Based on this study result, the HCV antibody test using multiple antibody detection rapid test by immunochromatography method has a good diagnostic value.


2014 ◽  
Vol 52 (7) ◽  
pp. 2650-2652 ◽  
Author(s):  
F. Gao ◽  
E. A. Talbot ◽  
C. H. Loring ◽  
J. J. Power ◽  
J. Dionne-Odom ◽  
...  

2013 ◽  
Vol 33 (3) ◽  
pp. 184-189 ◽  
Author(s):  
Young Joo Cha ◽  
Quehn Park ◽  
Eun-Suk Kang ◽  
Byung Chul Yoo ◽  
Kyoung Un Park ◽  
...  

Author(s):  
Jesha Mundodan ◽  
Samina Hasnain ◽  
Hayat Khogali ◽  
Soha Shawqi Al Bayat ◽  
Dina Ali ◽  
...  

Background: In response to the growing coronavirus disease 2019 (COVID-19) pandemic and the shortage of laboratory based molecular testing capacity and reagents, multiple diagnostic test manufacturers have developed rapid and easy to use devices to facilitate testing outside laboratory settings. These kits are either based on detection of proteins from SARS-CoV-2 virus or detection of antigen or human antibodies generated in response to the infection. However, it is important to understand their performance characteristics and they must be validated in the local population setting.Design and Methods: The objective is to assess the validity of the rapid test for IgG and IgM immunoglobulins compared to the current gold standard reverse transcription polymerase chain reaction (RT-PCR) test. A total of 16951 asymptomatic individuals were tested by the Ministry of Public Health track-and-trace team using both rapid immunodiagnostic test and RT-PCR as part of screening across various random settings with potential risk of community interaction prior to gradual lifting of restrictions in Qatar.  Rapid test was considered to be posiive if both IgG and IgM are positive, while only IgG/IgM positive was considered as rapid test negative. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated.Results: The sensitivity of rapid test kit was found to be 0.9%, whereas the specificity was found to be 97.8%. the PPV was found to be 0.3% whereas the NPV was found to be 99.4%.Conclusion: Based on the outcome and results of the study, it appears that the sensitivity and PPV of the rapid antibody test are low. As such, this test is not recommended for use to assist in taking clinic-based decisions or decisions related to quarantine/isolation.


2019 ◽  
Author(s):  
Tenzin Tenzin ◽  
Kelzang Lhamo ◽  
Purna B Rai ◽  
Dawa Tshering ◽  
Pema Gyamtsho ◽  
...  

Abstract Background: Rabies kills approximately 59,000 people in the world each year worldwide. Rapid and accurate diagnosis of rabies is important for instituting rapid containment measures and for advising the exposed people for postexposure treatment. The application of a rapid diagnostic tests in the field can greatly enhance disease surveillance activities, especially in resource poor settings.Methods: From 2012 to 2017, a total of 179 brain tissue samples collected from different animal species (113 dogs, 50 cattle, 10 cats, 3 goats, 2 horses, and 1 bear) suspected of having died due to rabies were selected and tested using the rapid immunochromatographic kit from BioNote© company and compared to the Gold Standard Fluorescent Antibody test (FAT) for diagnosis of rabies.Results: Among 179 samples examined in this study, there was concordance in results by the rapid test and FAT in 115 positive samples and 54 negative samples. Test result were discordant in 10 samples which were positive by FAT, but negative (false negative) by rapid kit. The rapid test kit showed a sensitivity of 92% (95% CI: 85.9 – 95.6) and specificity of 100% (95% CI: 93.4 – 100) using FAT as the gold standard. The positive and negative predicative values were found to be 100% (95% CI:96.7 – 100) and 84% (95% CI: 73.6 – 91.3), respectively. Overall there was 94.41% (95% CI: 90 – 96.9) test agreement (almost perfect agreement) between rapid test and FAT (Kappa value = 0.874).Conclusions: Our results demonstrate the potential value of the rapid test kit for countries with limited diagnostic resources, including Bhutan. The rapid kit’s inability to correctly detect 10 FAT-positive samples (10 out of 179 (5.6%) were false negatives) in our study could have been due to the low viral load in the samples (< 102.0LD50/0.03ml) which could not be detected by the rapid kit as compared with the FAT. The human factor related to the varying experiences of the technicians who performed the test in the field also may have influenced the test result. The rapid test kit is inexpensive, rapid and easy to use in the field or in laboratory setting without the need for special training and can support to enhance rabies surveillance in resource poor countries.


VASA ◽  
2008 ◽  
Vol 37 (1) ◽  
pp. 81-85
Author(s):  
Assadian ◽  
Assadian ◽  
Holak ◽  
Watkins-Riedel ◽  
Senekowitsch ◽  
...  

To evaluate whether dedicated access surgeons might have a significantly higher risk of acquiring hepatitis C infection compared to other vascular surgeons by assessing the prevalence of hepatitis C patients who are on chronic hemodialysis and to compare the frequency to patients undergoing elective vascular interventions. Patients and methods: A retrospective chart and data analysis of all patients on chronic hemodialysis was conducted. As a comparative group, the prevalence of anti-HCV antibodies and positive HCV RNA PCR among patients admitted for elective vascular surgery was assessed. Results: Of 285 patients on chronic hemodialysis, 202 (71%) were had both tests (antibody test for HCV and specific HCV RNA PCR testing). 5% (n = 11; CI95 = 3–10%) were antibody positive, and 4% (n = 8; CI95 = 2–8%) were also PCR positive and therefore infectious. One patient was acutely infected. Of 4963 vascular surgical patients, 1141 (23%) had an anti-HCV antibody ELISA test and specific HCV RNA PCR testing. 0.4% (n = 4; CI95 = 0.1–1%) were antibody positive and 0.2% (n = 2; CI95 = 0.03–0.7%) were also PCR positive and hence infectious. No acutely infected patient was detected in this population. The chance of operating on a HCV positive and infectious patient among hemodialysis patients was almost 27 times higher than among elective vascular surgical patients (P < 0.0001; OR = 26.56; CI95 = 5.42–253.40). Conclusions: Dedicated hemodialysis access surgeons have a higher risk to acquire hepatitis C infection compared to vascular surgeons performing all other elective vascular surgical interventions. To identify early infected surgeons operating on high risk HCV patient collectives and to start rapid treatment, PCR testing at regular intervals would be advisable.


2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
A. Jewett ◽  
A. A. Al-Tayyib ◽  
L. Ginnett ◽  
B. D. Smith

Background. The Centers for Disease Control and Prevention (CDC) recommends testing and linkage to care for persons most likely infected with hepatitis C virus (HCV), including persons with human immunodeficiency virus. We explored facilitators and barriers to integrating HCV point-of-care (POC) testing into standard operations at an urban STD clinic.Methods. The OraQuick HCV rapid antibody test was integrated at the Denver Metro Health Clinic (DMHC). All clients with at least one risk factor were offered the POC test. Research staff conducted interviews with clients (three HCV positive and nine HCV negative). Focus groups were conducted with triage staff, providers, and linkage-to-care counselors.Results. Clients were pleased with the ease of use and rapid return of results from the HCV POC test. Integrating the test into this setting required more time but was not overly burdensome. While counseling messages were clear to staff, clients retained little knowledge of hepatitis C infection or factors related to risk. Barriers to integrating the HCV POC test into clinic operations were loss to follow-up and access to care.Conclusion. DMHC successfully integrated HCV POC testing and piloted a HCV linkage-to-care program. Providing testing opportunities at STD clinics could increase identification of persons with HCV infection.


2021 ◽  
Vol 10 (4) ◽  
pp. 758
Author(s):  
Atikah Nurhesti ◽  
Solikhah Solikhah ◽  
Siti Nur Djannah

Coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Antibody rapid test is one of the COVID-19 screening tests that can be used in the community. The accuracy of the rapid antibody methods needs to be appropriately assessed, it is necessary to carry out a diagnostic accuracy study using a pairwise sensitivity and specificity analysis. This research aimed to assess the sensitivity and specificity of COVID-19 rapid tests, also assesses positive predictive value (PPV) and negative predictive value (NPV) of the rapid antibody test as a method of screening for COVID-19 in Sleman Regency, Indonesia. In total, 118 respondents who have contact with COVID-19 patients and have symptoms were enrolled in this study. The study was conducted on 118 patients who had been in contact with confirmed COVID-19 118 patients who met the close contact criteria were conducted a rapid antibody test. 64.41% patients were reactive. Real-time polymerase chain reaction (RT PCR) as a gold standard was also carried out for all patients and 63.56% affirmed positive for COVID-19. The sensitivity value was 97.33%, and the specificity value was 93.02%, while the positive predictive value (NPP) was 96.05%, and the negative predictive value (NPN) was 95.24%. These results meet the minimum recommendations for the screening method.


2019 ◽  
Vol 26 (09) ◽  
pp. 1413-1418
Author(s):  
Samreen Hameed ◽  
Syed Maaz Abdullah ◽  
Asad Ali ◽  
Sarmad Zahoor ◽  
Rabia Amin Butt ◽  
...  

Objectives: Hepatitis C Virus (HCV) infection is life threatening but with the advent of new antiviral agents is potentially curable. Its prevalence among healthy blood donors was estimated in Mayo Hospital, Lahore, Pakistan. The aim of this study was to help in estimating disease burden in addition to early diagnosis of asymptomatic individuals necessitating treatment. Study Design: Retrospective single centre cross-sectional study. Setting: Mayo Hospital, Lahore, Pakistan. Period: January 2016 to December 2017. Material and Methods: Blood donors were tested for Anti-HCV antibodies by qualitative test based on lateral flow immunoassay using commercially made rapid test kits. Results: In 2016 and 2017, a total of 76530 healthy blood donors were screened for anti-HCV antibodies. Out of 76530 donors, 2095 were found to have anti-HCV antibodies constituting cumulative percentage of 2.73%. The seroprevalence was 2.49% in 2016 and reached to 2.97% in 2017. Conclusion: Sero-prevalence of Hepatitis C among healthy blood donors is quite high at 2.73% and has slightly increased in 2017 compared to 2016. This dictates need for continued community awareness for prevention, early detection, and treatment. This study will be helpful for health policy makers to design more effective strategic planning to eradicate Hepatitis C infection.


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