Q1. A title should clearly indicate to the reader what the article is about.List 2 ways the title of the article achieved this purpose.(1.0 mark)
| Title of the article is Evaluation of the Xpert HCV Viral Load Finger-Stick Point-of-Care AssayThe article has fully achieved its purpose since:Firstly, the article has fully evaluated the effectiveness of Xpert HCV VL FS test for precisely diagnosing active infection from a finger-stick sample in 1 hour enabling single-visit HCV diagnosis.Secondly, it offers sound evaluation and substantiation as to how Xpert HCV VL FS test can precisely diagnosing active infection from a finger-stick sample in 1 hour enabling single-visit HCV diagnosis. |
Abstract:
Q2. Using information from the Abstract, describe the:a) major finding and b) conclusion of thearticle.(1.0 mark)
| Findings: Sensitivity of the Xpert HCV VL FS assay for HCV RNA quantification within samples gathered through means of finger-stick was 100.0% (95% CI, 93.9%–100.0%) as well as specificity was 100.0% (95% CI, 96.6%–100.0%). The Xpert HCV VL FS test could precisely identify vigorous infectivity from a sample of finger-stick in just 1 hour enabling single-visit HCV diagnosis.Conclusion: The Xpert HCV VL FS test could precisely discover active infection through a finger-stick sample in the time period of 1 hour enabling single-visit HCV diagnosis. |
Q3. In a broader context, what practical application/relevance does this study have? (1.0 mark)
| The study results hold the ability of significantly changing HCV infection clinical management. In research studies from Australia, the United States and Canada, amongst individuals testing positive for anti-HCV antibody, just 46%–73% of individuals obtained confirmatory HCV RNA testing (Yehia et. al., 2014). The capability of testing for HCV RNA through making use of finger-stick whole blood puts forward a considerable advancement in diagnostic testing of HCV, provided that accessible point-of-care assays, which could be carried out from capillary whole blood discover HCV antibodies and not HCV RNA (active infection) (Grebely et. al., 2017). |
Introduction:
Q4. Using 2 sentences in your own words, brieflysummarise the background context (problem) for the study? (1.0 marks)
| Worldwide, around 71 million individuals are suffering from hepatitis C virus (HCV) infection. In spite of the accessibility of effective and tolerable DAA (direct-acting antiviral therapies), just about 20 percent of this populace has been effectively diagnosed. As a result, in such as situation Point-of-care HCV (hepatitis C virus) RNA testing proves to be beneficial, allowing diagnosis of prevailing infection in just one visit. |
Q5. Using 1 sentence in your own words, explain what the study aimed to achieve?(1.0 mark)
| This particular study intended to evaluate the specificity as well as sensitivity of Xpert HCV Viral Load Finger-Stick assay (Xpert HCV VL FS) for HCV RNA detection (finger-stick) and the Xpert HCV Viral Load assay (plasma) compared with the Abbott RealTime HCV Viral Load assay by venepuncture. |
Research Design (Methods):
Q6. In a table, list and briefly explain the main aspects of the study design (e.g. location/cohort/sample size/duration/sample type/device/result analysis, etc.). (3.0marks)
| Aspect of study | From the study | Explanation |
| Location | Australia | Finger-stick capillary whole-blood samples as well as Plasma were collected from people situated within Australia |
| Cohort | Observational | The researchers observed what actually happened without intervening. |
| Sample Size | 223 | Between 3 August 2016 and 13 December 2016 223 participants were enrolled at 3 drug treatment clinics and 1 homelessness service in Australia. |
| Duration | 3 August 2016 and 13 December 2016 | Between 3 August 2016 and 13 December 2016 |
| Device Used | Observational | The researchers observed what actually happened without intervening |
| Sample Type | Age Group and history | The inclusion criteria involved sample above the age of 18 years, written informed approval, and a previous record of injecting drug use (candidates chosen from homelessness service were excluded from this criteria). |
| Analyte Measured | Different samples were taken | Finger-stick capillary whole-blood sample (100 μL for Xpert HCV VL FS assay), a venepuncture blood sample (standard of care clinical testing and storage for HCV RNA testing), a self-administered survey on tablet computer (sociodemographic characteristics, drug use, liver and HCV knowledge), liver stiffness measurement by transient elastography (FibroScan), and a clinical HCV assessment (performed by a nurse) |
| Results Analysis | Detectable and Quantifiable thresholds | The specificity as well as sensitivity of the Xpert HCV Viral Load pointof-care test to detect HCV RNA within plasma samples gathered through venepuncture along with capillary whole-blood samples gathered through finger-stick was evaluated by making use of quantifiable and detectable thresholds |
| Other | Approval | The research protocol received approval from St. Vincent’s Hospital, Sydney Human Research Ethics Committee. |
Q7. List 2 strengths of the study design and explain why they are strengths (e.g. trial type, sample size, etc.) (1.0mark)
| Sample size- Sample size chosen for the study for quite appropriate with respect to the research aims and purpose.Research design- The research approach adopted was quite effective in evaluating the stated purpose of the research. |
Data Analysis (Results):
Q8. a) Outline the main ways the study data wassummarisedfor the reader.(1.0 mark)
b) Was the study data easy to understand? (0.5 mark)
c) If so, why? If not, how could the data be presented more clearly?(1.0 mark)
| The study data has been summarized in a very systematic and proper manner. The reader can clearly understand the data and link it with the stated research purpose. From the very beginning there is proper flow of information related the research results and their analysis. |
Q9. Did the study have inclusion or exclusion criteria (for subjects)? Was any data excluded from analysis, If so, why? (0.5 mark)
| Yes, the study had certain inclusion criteria and certain data was excluded from analysis. This was chiefly done to make sure that no irrelevant and inappropriate data to be part of research or analysis process. |
Q10. In your opinion, was the data analysis rigorous enough to substantiate the claims? (1.0 mark)
| Yes, I completely believe that the data analysis was rigorous enough for substantiating the claims. |
Discussion:
Q11. List the most important findingsfrom thestudy andexplain how they were adequately highlighted in the article discussion.
(2.0 marks)
| Sensitivity of the Xpert HCV VL FS assay for HCV RNA quantification within samples gathered through means of finger-stick was 100.0% (95% CI, 93.9%–100.0%) as well as specificity was 100.0% (95% CI, 96.6%–100.0%). The Xpert HCV VL FS test could precisely identify vigorous infectivity from a sample of finger-stick in just 1 hour enabling single-visit HCV diagnosis.The findings have been adequately highlighted by including them in different sections of the study including abstract, analysis, results and discussion. |
Q12. List one weakness/limitation of this study and suggest a possible way that this could be overcome?
(2.0 marks)
| Research is required for evaluating Xpert HCV VL FS testing cost-efficiency in diverse settings and conditions, taking in a consideration of conditions where there might be invalid results and errors.The incorporation of point-of-care testing like fraction of HCV “test and treat” approaches within high-prevalence conditions as well as settings might offer a chance for enhancing diagnosis, HCV treatment and care linkage. |
Conclusion:
Q13. What newperspective did the article provide on the topic?(1.0 mark)
| The research demonstrated a sound specificity and sensitivity of the Xpert HCV VL Fingerstick test for HCV RNA quantification amongst individuals attending homelessness and drug health provisions. |
Q14. Make 1 suggestion for future research that relates to the article. Explain your response.(1.0 mark)
| The Xpert HCV VL FS test needs to be examined more as a screening technique for HCV RNA recognition within high-prevalence conditions, chiefly among provisions for PWID. The efforts for eliminating HCV as a worldwide public health issue would need approaches for enhancing HCV testing as well as diagnosis worldwide, taking in the formation of assays for speedy HCV RNA detection. |
Bibliography:(1.0mark)
Include the full Harvard reference of the paper you reviewed, and any other materials referenced
Grebely, J., Lamoury, F. M. J., Hajarizadeh, B., et al. (2017). LiveRLife Study Group. Evaluation of the Xpert HCV Viral Load point-of-care assay from venepuncture-collected and finger-stick capillary whole-blood samples: a cohort study. Lancet Gastroenterol Hepatol, 2, 514–20
Francois, M., Sahar, B., Behzad, H., Alison, D. M., Marianne, M., Elena, I., et. al. (2018). Evaluation of the Xpert HCV Viral Load Finger-Stick Point-of-Care Assay. JID, 217
Yehia, B. R., Schranz, A. J. and Umscheid, C. A. (2014). The treatment cascade for chronic hepatitis C virus infection in the United States: a systematic review and meta-analysis. PLoS One, 9, e101554
