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Diagnosis of patients with suspected chronic hepatitis C infection
Adrián Gadano
,
Corresponding author
adrian.gadano@hospitalitaliano.org.ar

Correspondence and reprint request:
, Omar Galdame*, Sebastián Marciano*
* Sección Hepatología. Hospital Italiano de Buenos Aires - Argentina.
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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Introduction</span><p id="p0075" class="elsevierStylePara elsevierViewall">There is an important population of patients who are currently infected with hepatitis C virus &#40;HCV&#41; but who are undiagnosed and asymptomatic&#46; The optimal approach to detecting HCV infection involves screening for risk factors of exposure to the virus and only testing selected individuals at a risk&#46;</p><p id="p0080" class="elsevierStylePara elsevierViewall">Throughout the world&#44; blood transfusions from infectious donors&#44; unsafe therapeutic injection practices&#44; and illegal intravenous drug use have been the predominant modes of transmission of HCV infection&#46; In most developed countries&#44; blood donor testing has virtually eliminated transfusion-related transmission of HCV&#44; and nosocomial and iatrogenic transmission is uncommon&#46; In these countries&#44; illegal intravenous drug use has been identified as the major risk factor during the past 40 years and the highest prevalence of infection is found in young to middle-aged adults&#46; In many developing countries&#44; unsafe therapeutic injection practices appears to be responsible for the geographic clustering of high rates of infection because of inadequate or nonexistent supplies of sterile syringes&#44; administration of injections by nonprofessionals outside the medical setting&#44; and administration of medications by injection&#46; In some countries&#44; the risk from unsafe therapeutic injections has decreased&#44; as indicated by high prevalence rates of HCV infection only in older people&#46; In other countries&#44; this transmission mode continues to be a major source of HCV infection&#44; with high prevalence rates of HCV infection found among people in all age groups&#46;</p><p id="p0085" class="elsevierStylePara elsevierViewall">Characterizing the epidemiology of hepatitis C in individual countries is crucial to developing and implementing effective preventive measures&#46; For some countries&#44; ensuring safe blood supplies and healthcare-related procedures is the highest priority&#46; For others&#44; the priorities are the prevention of illegal injection drug use&#44; harm reduction counseling&#44; and testing to identify HCV-infected people for medical evaluation and management&#46;<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a></p><p id="p0090" class="elsevierStylePara elsevierViewall">Because symptoms are generally absent in individuals with chronic HCV infection&#44; recognition of infection requires risk factor screening&#44; which should be performed&#44; when indicated&#44; in combination with appropriate HCV testing and counseling&#46;<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a><a class="elsevierStyleCrossRef" href="#t0005">Table 1</a> lists people who should be routinely screened for HCV infection&#46;<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a></p><elsevierMultimedia ident="t0005"></elsevierMultimedia></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Diagnosis of Chronic Hepatitis C</span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Laboratory testing</span><p id="p0095" class="elsevierStylePara elsevierViewall">The repertoire of virological markers currently used for the clinical management of patients with hepatitis C includes serologic assays &#40;ELISA or immunoblot assays&#41;&#44; which detect specific antibodies &#40;IgG&#41; to HCV&#44; and virological assays&#44; which detect serum&#44; HCV RNA by highly sensitive qualitative and quantitative techniques&#46; These assays play no role in the assessment of disease severity or prognosis&#46;</p><p id="p0100" class="elsevierStylePara elsevierViewall">The use of serologic and virological tests has become essential in the management of HCV infection in order to&#58;<ul class="elsevierStyleList" id="li0020"><li class="elsevierStyleListItem" id="list0075"><span class="elsevierStyleLabel">&#8226;</span><p id="p0105" class="elsevierStylePara elsevierViewall">Diagnose infection&#46;</p></li><li class="elsevierStyleListItem" id="list0080"><span class="elsevierStyleLabel">&#8226;</span><p id="p0110" class="elsevierStylePara elsevierViewall">Assess the virological response to therapy and guide treatment decisions&#46;</p></li></ul></p></span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Serologic assays</span><p id="p0115" class="elsevierStylePara elsevierViewall">Tests that detect anti-HCV are used both to screen for and to diagnose HCV infection&#46; Such tests detect antibodies directed against various HCV epitopes in plasma or in serum&#46; Three enzyme immunoassays &#40;EIAs&#41; that have been approved by the US Food and Drug Administration &#40;FDA&#41; for clinical use are the Abbott HCV EIA 2&#46;0 &#40;Abbott Laboratories&#44; Abbott Park&#44; IL&#41;&#44; ORTHO HCV Version 3&#46;0 ELISA &#40;Ortho-Clinical Diagnostics&#44; Raritan&#44; NJ&#41;&#44; and the enhanced chemiluminescence immunoassay &#40;CIA&#41; VITROS Anti-HCV assay &#40;Ortho-Clinical Diagnostics&#44; Raritan&#44; NJ&#41;&#46; The specificity of current EIAs for anti-HCV is greater than 99&#37;&#59;<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> however&#44; sensitivity is more difficult to evaluate&#46;</p><p id="p0120" class="elsevierStylePara elsevierViewall">These tests can occasionally provide false positive results&#44; which is why confirmation using virological assays to determine HCV RNA may be necessary&#46; Undertaking confirmation tests is essential in patients with normal alanino aminotransferase &#40;ALT&#41; levels and in patients with elevated levels of gamma globulin&#46; Outside these circumstances&#44; as for the great majority of patients who are anti-HCV positive with elevated ALT levels&#44; it is not essential to carry out confirmation tests&#46;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">6</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">7</span></a></p><p id="p0125" class="elsevierStylePara elsevierViewall">The recombinant immunoblot assay Chiron RIBA HCV 3&#46;0 SIA is also FDA approved&#46; However&#44; the widespread availability of nucleic acid testing has rendered RIBA testing for HCV clinically obsolete&#46;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">8</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a></p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Virological assays</span><p id="p0130" class="elsevierStylePara elsevierViewall">Historically&#44; the qualitative assays have been more sensitive&#46; With the recent availability of realtime polymerase chain reaction &#40;PCR&#41;-based assays and transcription-mediated amplification &#40;TMA&#41; assays&#44; with a sensitivity of 10&#8211;50 IU&#47;mL&#44; qualitative assays are being replaced in most settings by highly sensitive quantitative real-time PCR assays&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">10</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">11</span></a></p><p id="p0135" class="elsevierStylePara elsevierViewall">Another virological assay is the HCV core antigen EIA assay&#44; which can detect total HCV core antigen in serum&#46; The HCV core antigen levels are expressed in pg&#47;mL and closely correlate with HCV RNA levels&#46; One picogram of HCV core antigen is equivalent to approximately 8&#44;000 IU of HCV RNA&#46; Although the HCV core antigen assay can be used as a surrogate marker of HCV replication to monitor the early virological response during antiviral therapy&#44; its clinical use is limited by the low sensitivity as the current version of the assay does not detect HCV core antigen below an HCV RNA level of 20&#44;000 IU&#47;mL&#46;<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">12</span></a></p><p id="p0140" class="elsevierStylePara elsevierViewall">All currently available assays have excellent specificity&#44; in the range of 98 to 99&#37;&#46; Since the IUs have been refined and standardized across laboratories throughout the world&#44; they are now the preferred unit for reporting test results&#44; rather than viral copy number&#46;<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">13</span></a><span class="elsevierStyleSup">&#44;</span><a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">14</span></a></p><p id="p0145" class="elsevierStylePara elsevierViewall">These assays are mainly used in the early monitoring of the virological response to antiviral therapy and in the prediction of treatment outcome&#46; For monitoring purposes&#44; it is important to use the same laboratory test before and during therapy&#46;</p><p id="p0150" class="elsevierStylePara elsevierViewall">The commercial assays available for the detection &#40;qualitative assays&#41; or quantification &#40;quantitative assays&#41; of HCV RNA are listed in <a class="elsevierStyleCrossRef" href="#t0010">Tables 2</a> and <a class="elsevierStyleCrossRef" href="#t0015">3</a>&#46;</p><elsevierMultimedia ident="t0010"></elsevierMultimedia><elsevierMultimedia ident="t0015"></elsevierMultimedia></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Diagnosis of chronic HCV infection and interpretation of assays</span><p id="p0155" class="elsevierStylePara elsevierViewall">In patients with clinical or biological signs of chronic liver disease&#44; screening for chronic HCV infection generally requires testing for antibodies against both HCV &#40;anti-HCV&#41; and HCV RNA&#46; A sensitive quantitative HCV RNA assay is recommended for diagnosis because it also provides information on the viremia&#46; Although here we recommend the use of quantitative assays&#44; their use in Latin American countries will depend on the availability of tests&#46;</p><p id="p0160" class="elsevierStylePara elsevierViewall">The differentiation between acute and chronic HCV infection depends on the clinical presentation&#44; namely the presence of symptoms&#44; such as jaundice&#44; and whether or not there is a prior history of prolonged elevated ALT levels&#46; After acute exposure&#44; detection of HCV RNA usually precedes the detection of antibody reactivity in serum&#59; HCV RNA can be identified as early as two weeks following exposure whereas anti-HCV antibodies are generally not detected before 8&#8211;12 weeks&#46; The positive response may vary between these two markers of HCV infection&#44; requiring careful analysis for interpretation <a class="elsevierStyleCrossRef" href="#t0020">&#40;Table 4&#41;</a>&#46;</p><elsevierMultimedia ident="t0020"></elsevierMultimedia><p id="p0165" class="elsevierStylePara elsevierViewall">It is possible for both anti-HCV and HCV RNA to be positively identified in a patient with a recent elevation of ALT levels&#46; This scenario is consistent with either acute HCV infection when there is a recent risk of exposure&#44; with an exacerbation of a chronic HCV infection&#44; or with an acute hepatitis of other etiology in a patient with chronic HCV infection&#46; Another possibility is the detection of anti-HCV but not HCV RNA&#46; This scenario most commonly represent a recovery from HCV infection&#46; Less likely it may represent an acute HCV infection during a period of transient clearance of HCV RNA&#44; an anti-HCV false positive or an HCV RNA false negative result&#46; The reverse scenario&#44; a negative anti-HCV with a positive HCV RNA&#44; can be seen in the early stage of an acute infection prior to the development of antibodies and in cases of chronic infection in immunosuppressed patients&#46; Alternatively&#44; it may represent a false positive the HCV RNA result&#46; For all cases&#44; retesting for anti-HCV and HCV RNA 4&#8211;6 months later should resolve the issue&#46; Finally&#44; if the patient has elevated ALT levels but the tests for anti-HCV and HCV RNA are negative&#44; both acute and chronic hepatitis C may be excluded and another diagnosis should be considered&#46;</p><p id="p0170" class="elsevierStylePara elsevierViewall">Approximately 30&#37; of the patients with chronic HCV infection have normal ALT levels at diagnosis&#44; regardless of the age and gender&#44; and many of them maintain normal liver function tests during prolonged follow-up&#46; Reactivation of liver disease with ALT flares may be seen in a significant number of these cases over time&#46; Some of these HCV patients with normal ALT levels have significant fibrosis or cirrhosis&#44; as shown by liver biopsy&#46; Virological or biochemical testing cannot predict the presence of significant liver disease or the risk of future ALT flares&#46;<a class="elsevierStyleCrossRef" href="#bib0075"><span class="elsevierStyleSup">15</span></a></p></span></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Recommendations</span><p id="p0175" class="elsevierStylePara elsevierViewall"><ul class="elsevierStyleList" id="li0025"><li class="elsevierStyleListItem" id="list0085"><span class="elsevierStyleLabel">1&#46;</span><p id="p0180" class="elsevierStylePara elsevierViewall">Patients suspected of having acute or chronic HCV infection should first be tested for anti-HCV <span class="elsevierStyleBold">&#40;Class I&#44; Level B&#41;&#46;</span></p></li><li class="elsevierStyleListItem" id="list0090"><span class="elsevierStyleLabel">2&#46;</span><p id="p0185" class="elsevierStylePara elsevierViewall">HCV RNA testing should be performed in&#58;<ul class="elsevierStyleList" id="li0030"><li class="elsevierStyleListItem" id="list0095"><span class="elsevierStyleLabel">a&#41;</span><p id="p0190" class="elsevierStylePara elsevierViewall">Patients who test positive for anti-HCV <span class="elsevierStyleBold">&#40;Class I&#44; Level B&#41;&#46;</span></p></li><li class="elsevierStyleListItem" id="list0100"><span class="elsevierStyleLabel">b&#41;</span><p id="p0195" class="elsevierStylePara elsevierViewall">Patients for whom antiviral treatment is being considered&#44; using a sensitive quantitative assay <span class="elsevierStyleBold">&#40;Class I&#44; Level A&#41;&#46;</span></p></li><li class="elsevierStyleListItem" id="list0105"><span class="elsevierStyleLabel">c&#41;</span><p id="p0200" class="elsevierStylePara elsevierViewall">Patients with unexplained liver disease whose anti-HCV test is negative and who are immunosuppresed or suspected of having acute HCV infection <span class="elsevierStyleBold">&#40;Class I&#44; Level B&#41;&#46;</span></p></li></ul></p></li><li class="elsevierStyleListItem" id="list0110"><span class="elsevierStyleLabel">3&#46;</span><p id="p0205" class="elsevierStylePara elsevierViewall">HCV genotyping should be performed in all HCV-infected patients prior to interferon-based treatment in order to determine the dose and duration of therapy and to estimate the likelihood of response <span class="elsevierStyleBold">&#40;Class I&#44; Level A&#41;&#46;</span></p></li></ul></p><p id="p0210" class="elsevierStylePara elsevierViewall">Indiscriminate screening is not recommended for&#58;<ul class="elsevierStyleList" id="li0035"><li class="elsevierStyleListItem" id="list0115"><span class="elsevierStyleLabel">a&#41;</span><p id="p0215" class="elsevierStylePara elsevierViewall">The general population&#46;</p></li><li class="elsevierStyleListItem" id="list0120"><span class="elsevierStyleLabel">b&#41;</span><p id="p0220" class="elsevierStylePara elsevierViewall">Non household contacts of HCV infected patients&#46;</p></li><li class="elsevierStyleListItem" id="list0125"><span class="elsevierStyleLabel">c&#41;</span><p id="p0225" class="elsevierStylePara elsevierViewall">Pregnant women&#46;</p></li><li class="elsevierStyleListItem" id="list0130"><span class="elsevierStyleLabel">d&#41;</span><p id="p0230" class="elsevierStylePara elsevierViewall">Health care workers who are not at significant risk&#46;</p></li></ul></p></span></span>"
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          "titulo" => "Key words"
          "identificador" => "xpalclavsec1126748"
          "palabras" => array:4 [
            0 => "Hepatitis C"
            1 => "Diagnosis"
            2 => "Risk factors"
            3 => "Serologic tests"
          ]
        ]
      ]
    ]
    "tieneResumen" => true
    "resumen" => array:1 [
      "en" => array:2 [
        "titulo" => "Abstract"
        "resumen" => "<span id="abs0005" class="elsevierStyleSection elsevierViewall"><p id="sp0025" class="elsevierStyleSimplePara elsevierViewall">The current optimal approach to detecting hepatitis C virus &#40;HCV&#41; infection involves screening people for risk factors and only testing selected individuals at risk&#46; Blood transfusion from infectious donors&#44; unsafe therapeutic injection practices&#44; and illegal intravenous drug use have been the predominant modes of transmissiom of HCV infection&#46; Virological markers that are currently used for the clinical management of patients with hepatitis C include serologic assays &#40;ELISA or immunoblot assays&#41;&#44; which detect specific antibodies &#40;IgG&#41; to HCV&#44; and virological assays&#44; which detect serum HCV RNA&#44; by highly sensitive qualitative and quantitative techniques&#46; The applicability of these tests is for the diagnoses and monitoring of the treatment but they have no role in the assessment of disease severity or prognosis&#46; Patients diagnosed with HCV infection must be educated in order to avoid the spread of the disease to other people&#46;</p></span>"
      ]
    ]
    "multimedia" => array:4 [
      0 => array:7 [
        "identificador" => "t0005"
        "etiqueta" => "<span class="elsevierStyleBold">Table 1&#46;</span>"
        "tipo" => "MULTIMEDIATABLA"
        "mostrarFloat" => true
        "mostrarDisplay" => false
        "tabla" => array:2 [
          "leyenda" => "<p id="npara0005" class="elsevierStyleSimplePara elsevierViewall">Ghany MG&#44; Strader DB&#44; Thomas DL&#44; Seeff LB&#46; Diagnosis&#44; Management and treatment of Hepatitis C&#58; an update&#46; Hepatology 2009&#59; 49&#40;4&#41;&#58;1335&#8211;74&#46;</p>"
          "tablatextoimagen" => array:1 [
            0 => array:2 [
              "tabla" => array:1 [
                0 => """
                  <table border="0" frame="\n
                  \t\t\t\t\tvoid\n
                  \t\t\t\t" class=""><tbody title="tbody"><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle"><ul class="elsevierStyleList" id="li0005"><li class="elsevierStyleListItem" id="list0005"><span class="elsevierStyleLabel">&#8226;</span><p id="p0005" class="elsevierStylePara elsevierViewall">People who have injected illicit drugs in the recent or remote past&#44; including those who have injected only once and do not consider themselves to be drug users&#46;</p></li><li class="elsevierStyleListItem" id="list0010"><span class="elsevierStyleLabel">&#8226;</span><p id="p0010" class="elsevierStylePara elsevierViewall">People with conditions associated with a high prevalence of HCV infection including those&#58;<ul class="elsevierStyleList" id="li0010"><li class="elsevierStyleListItem" id="list0015"><span class="elsevierStyleLabel">&#176;</span><p id="p0015" class="elsevierStylePara elsevierViewall">With HIV infection&#46;</p></li><li class="elsevierStyleListItem" id="list0020"><span class="elsevierStyleLabel">&#176;</span><p id="p0020" class="elsevierStylePara elsevierViewall">With hemophilia who received clotting factor concentrates prior to 1987&#46;</p></li><li class="elsevierStyleListItem" id="list0025"><span class="elsevierStyleLabel">&#176;</span><p id="p0025" class="elsevierStylePara elsevierViewall">Who have ever received hemodialysis&#46;</p></li><li class="elsevierStyleListItem" id="list0030"><span class="elsevierStyleLabel">&#176;</span><p id="p0030" class="elsevierStylePara elsevierViewall">With unexplained abnormal liver function tests&#46;</p></li></ul></p></li><li class="elsevierStyleListItem" id="list0035"><span class="elsevierStyleLabel">&#8226;</span><p id="p0035" class="elsevierStylePara elsevierViewall">Recipients of transfusions or organ transplants prior to July 1992 including persons who&#58;<ul class="elsevierStyleList" id="li0015"><li class="elsevierStyleListItem" id="list0040"><span class="elsevierStyleLabel">&#176;</span><p id="p0040" class="elsevierStylePara elsevierViewall">Were notified that they had received blood from a donor who later tested positive for HCV infection&#46;</p></li><li class="elsevierStyleListItem" id="list0045"><span class="elsevierStyleLabel">&#176;</span><p id="p0045" class="elsevierStylePara elsevierViewall">Received a transfusion of blood or blood products&#46;</p></li><li class="elsevierStyleListItem" id="list0050"><span class="elsevierStyleLabel">&#176;</span><p id="p0050" class="elsevierStylePara elsevierViewall">Received an organ transplant&#46;</p></li></ul></p></li><li class="elsevierStyleListItem" id="list0055"><span class="elsevierStyleLabel">&#8226;</span><p id="p0055" class="elsevierStylePara elsevierViewall">Children born to HCV-infected mothers&#46;</p></li><li class="elsevierStyleListItem" id="list0060"><span class="elsevierStyleLabel">&#8226;</span><p id="p0060" class="elsevierStylePara elsevierViewall">Healthcare&#44; emergency medical&#44; and public safety workers after a needle stick injury or mucosal exposure to HCV-positive blood&#46;</p></li><li class="elsevierStyleListItem" id="list0065"><span class="elsevierStyleLabel">&#8226;</span><p id="p0065" class="elsevierStylePara elsevierViewall">People who are or have been in prison&#46;</p></li><li class="elsevierStyleListItem" id="list0070"><span class="elsevierStyleLabel">&#8226;</span><p id="p0070" class="elsevierStylePara elsevierViewall">Current sexual partners of HCV-infected people&#46;</p></li></ul>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
                  """
              ]
              "imagenFichero" => array:1 [
                0 => "xTab2066280.png"
              ]
            ]
          ]
        ]
        "descripcion" => array:1 [
          "en" => "<p id="sp0005" class="elsevierStyleSimplePara elsevierViewall">People for whom HCV screening is recommended&#46;</p>"
        ]
      ]
      1 => array:7 [
        "identificador" => "t0010"
        "etiqueta" => "<span class="elsevierStyleBold">Table 2&#46;</span>"
        "tipo" => "MULTIMEDIATABLA"
        "mostrarFloat" => true
        "mostrarDisplay" => false
        "tabla" => array:2 [
          "leyenda" => "<p id="npara0010" class="elsevierStyleSimplePara elsevierViewall">RT-PCR&#58; Reverse transcription polymerase chain reaction&#46; TMA&#58; Transcription-mediated amplification&#46; Ghany MG&#44; Strader DB&#44; Thomas DL&#44; Seeff LB&#46; Diagnosis&#44; Management and treatment of Hepatitis C&#58; an update&#46; Hepatology 2009&#59;49&#40;4&#41;&#58;1335&#8211;1374&#46;</p>"
          "tablatextoimagen" => array:1 [
            0 => array:2 [
              "tabla" => array:1 [
                0 => """
                  <table border="0" frame="\n
                  \t\t\t\t\tvoid\n
                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="middle" scope="col">Assay and manufacturer&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="center" valign="middle" scope="col">Method of detection&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="center" valign="middle" scope="col">Lower limit IU&#47;mL&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="center" valign="middle" scope="col">Setting&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="middle">Amplicor HCV v2&#46;0 &#40;Roche Molecular Systems&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">Manual RT-PCR&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">50&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">Diagnosis and monitoring&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="middle">Cobas Amplicor HCV v2&#46;0 &#40;Roche Molecular Systems&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">Semiautomated RT-PCR&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">50&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">Diagnosis and monitoring&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="middle">Ampliscreen &#40;Roche Molecular Systems&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">Semiautomated RT-PCR&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">&#60; 50&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">Blood screening&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="middle">Versant HCV RNA Qualitative Assay &#40;Siemens&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">Semiautomated TMA&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">10&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">Diagnosis and monitoring&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="middle">Procleix HIV-1&#47;HCV Assay &#40;Chiron Corporation&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">Manual TMA&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">&#60; 50&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">Blood screening&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
                  """
              ]
              "imagenFichero" => array:1 [
                0 => "xTab2066281.png"
              ]
            ]
          ]
        ]
        "descripcion" => array:1 [
          "en" => "<p id="sp0010" class="elsevierStyleSimplePara elsevierViewall">FDA-approved qualitative assays for detection of HCV RNA&#46;</p>"
        ]
      ]
      2 => array:7 [
        "identificador" => "t0015"
        "etiqueta" => "<span class="elsevierStyleBold">Table 3&#46;</span>"
        "tipo" => "MULTIMEDIATABLA"
        "mostrarFloat" => true
        "mostrarDisplay" => false
        "tabla" => array:2 [
          "leyenda" => "<p id="npara0015" class="elsevierStyleSimplePara elsevierViewall">RT-PCR&#58; Reverse transcription polymerase chain reaction&#46; TMA&#58; Transcription-mediated amplification&#46; Ghany MG&#44; Strader DB&#44; Thomas DL&#44; Seeff LB&#46; Diagnosis&#44; Management and treatment of Hepatitis C&#58; an update&#46; Hepatology 2009&#59;49&#40;4&#41;&#58;1335&#8211;1374&#46;</p>"
          "tablatextoimagen" => array:1 [
            0 => array:2 [
              "tabla" => array:1 [
                0 => """
                  <table border="0" frame="\n
                  \t\t\t\t\tvoid\n
                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="middle" scope="col">Assay&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="center" valign="middle" scope="col">Method&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="center" valign="middle" scope="col">IU&#47;mL Conversion factor&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="center" valign="middle" scope="col">Dynamic range &#40;IU&#47;mL&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="center" valign="middle" scope="col">FDA approved&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="middle">&#8226; Amplicor HCV Monitor &#40;Roche Molecular Systems&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">Manual RT-PCR&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">0&#46;9 copies&#47;mL&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">600-500&#44;000&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">Yes&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="middle">&#8226; Cobas Amplicor HCV Monitor V2&#46;0 &#40;Roche Molecular Systems&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">Semiautomated RT-PCR&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">2&#46;7 copies&#47;mL&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">600-500&#44;000&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">Yes&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="middle">&#8226; Versant HCV RNA 3&#46;0 Assay &#40;bDNA&#41; &#40;Siemens Diagnostics&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">Semiautomated bDNA&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">5&#46;2 copies&#47;mL&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">615-7&#44;700&#44;000&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">Yes&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="middle">&#8226; LCx HCV RNA-Quantitative Assay &#40;Abbott Diagnostics&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">Semiautomated RT-PCR&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">3&#46;8 copies&#47;mL&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">25-2&#44;630&#44;000&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">No&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="middle">&#8226; SuperQuant &#40;National Genetics Institute&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">Semiautomated RT-PCR&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">3&#46;4 copies&#47;mL&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">30-1&#44;470&#44;000&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">No&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="middle">&#8226; Cobas Taqman HCV Test &#40;Roche Molecular Systems&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">Semiautomated real-time PCR&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">43-69&#44;000&#44;000&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">Yes&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="middle">&#8226; Abbott RealTime &#40;Abbott Diagnostics&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">Semiautomated RT-PCR&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="center" valign="middle">12-100&#44;000&#44;000&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
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Article information
ISSN: 16652681
Original language: English
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es en pt

¿Es usted profesional sanitario apto para prescribir o dispensar medicamentos?

Are you a health professional able to prescribe or dispense drugs?

Você é um profissional de saúde habilitado a prescrever ou dispensar medicamentos