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Letter to the Editor
Confirmation of antibodies against hepatitis C virus by recombinant immunoblot: Is it really an improvement to abandon it?
Confirmación de anticuerpos frente al virus de la hepatitis C mediante inmunoblot recombinante: ¿es realmente una mejora abandonarlo?
Ana Avellón Calvoa,
Corresponding author
aavellon@isciii.es

Corresponding author.
, José Manuel Echevarría Mayob
a Laboratorio de Referencia e Investigación en Hepatitis Víricas, Unidad de Hepatitis, Centro Nacional de Microbiología, Instituto de Salud Carlos III, Majadahonda, Madrid, Spain
b Facultad de Biología, Universidad Complutense de Madrid, Spain
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">In 2013&#44; following discontinuation of the FDA-approved recombinant immunoblot assay &#40;RIBA&#41;&#44; the USA Centers for Disease Control &#40;CDC&#41; updated their HCV testing algorithm with the withdrawal of the RIBA as supplemental test for anti-HCV and the recommendation of using only nucleic acid amplification test &#40;NAAT&#41;&#44; following anti-HCV screening reactive result&#46; Results of a meta-analysis published in 2017&#44; showed that the specificity of the methods in use for screening of antibodies against hepatitis C virus &#40;anti-HCV&#41; was excellent&#44;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">1</span></a> accordingly&#44; the 2017 World Health Organization &#40;WHO&#41; recommendations also suggested to perform NAAT for chronic HCV confirmation following a reactive HCV serological test&#44;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">2</span></a> excluding again RIBA from recommendations&#46; Accordingly&#44; recommendations recently published in this journal by a group of experts from several Spanish hospitals parallel WHO and CDC guidelines&#46;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">3</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">There are several points to consider regarding these recommended guidelines&#58;</p><p id="par0015" class="elsevierStylePara elsevierViewall">Among most recent studies&#44; the results of a study in Egypt in 2016&#44;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">4</span></a> indicate the necessity of confirmation by RIBA in a country with a high prevalence of HCV infection because false positive screening results can occur quite frequently &#40;28&#46;6&#37; in health care workers&#41;&#46; On the other hand&#44; a study carried out in a low HCV prevalence setting&#44; published in 2017 by the Division of Viral Hepatitis National Center for HIV&#44; Hepatitis&#44; STD&#44; and TB Prevention&#44; at CDC&#44;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">5</span></a> also indicates a high frequency of false-positive anti-HCV screening results &#40;a false positive rate up to 22&#37; was observed&#41; stating that &#8220;<span class="elsevierStyleItalic">screening persons in a population with low prevalence of a disease leads to many false-positives that may have health&#44; economic and psychological impacts on patients and providers&#8221;</span>&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">5</span></a> Then&#44; despite high specificity performance of the tests&#44; the occurrence of false positive screening results seems to be significant &#40;up 20&#37;&#41; both in areas of high and low prevalence of HCV infection&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">The decision to exclude confirmation by RIBA from diagnostic algorithms is partially based on the assumption that a test detecting viremia following a reactive result on an anti-HCV screening test will effectively discard false positive results&#46; This assumption should be nuanced&#58; Firstly&#44; although NAAT testing will indirectly confirm a screening reactive result only in case it is positive&#44; absence of viremia does not exclude the true presence of anti-HCV&#46; Secondly&#44; NAAT testing will not identify in any case patients who have contacted the virus in the past but successfully resolved the acute infection&#46; With the withdrawal of supplemental test for anti-HCV&#44; it became challenging to discriminate false-positive results from resolved HCV infection&#46; The approach of performing NAAT on screening reactive samples&#44; will indeed correctly identify acute or chronic infections&#44; however&#44; it will not correctly identify the true HCV status of all other persons&#46; These persons will consequently receive very imprecise information about their real HCV status&#46; It is not surprising&#44; therefore&#44; that three quarters of the Spanish hospitals surveyed by the authors of the revision cited above declare they still perform RIBA tests to confirm the reactive samples in the screening&#46;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">3</span></a></p><p id="par0025" class="elsevierStylePara elsevierViewall">Accurate interpretation of anti-HCV-reactive results and a clear distinction between past&#44; resolved HCV infection and a false-positive results is needed because of several aspects&#46; First&#44; a false positive result may have significant consequences for the patient in terms of time and cost&#46; Second&#44; if previous contact with HCV is confirmed&#44; the patient would require prevention advice and continuous monitoring since reinfection could occur&#46; Third&#44; in a quality health care system&#44; it seems a legitimate demand from all patients to receive information of equal quality on the results obtained with laboratory diagnostic tests that have been prescribed and performed&#46; Fourth&#44; individuals with a false-positive anti-HCV result would be incorrectly banned from donating blood&#44; having a psychological impact on these persons and an impact on the available blood supply&#46; Finally&#44; in the Public Health field&#44; abandoning correct information on the true HCV status would be unacceptable&#44; since this would generate prevalence data quite far from reality due to the false positive results&#44; which are still frequent&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">In conclusion&#44; we cannot agree with the recommendation to exclude the confirmation of anti-HCV by RIBA tests from the diagnostic test algorithm for HCV infection&#46; We strongly encourage test centers to continue confirmatory testing in order to preserve the excellent quality of care provided to their patients&#46;</p></span>"
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