A clinical, epidemological, laboratorial, histological and ultrasonographical evaluation of anti-HCV EIA-2 positive blood donors

Between 1992 and 1997, 790 blood donors with anti-HCV EIA-2 strongly reagent (relationship between the sample optical density/cut-off > 3) detected at the blood bank serological screening, were evaluated in ambulatory environment. They were all negative for Chagas disease, syphilis, hepatitis B (HBsAg) and AIDS. Blood samples were collected at the first ambulatorial evaluation, for hemogram, biochemical tests and new serological tests for HCV (anti-HCV EIA-2). In blood samples of 226 repeatedly reagent anti-HCV EIA-2 blood donors, supplementary "immunoblot" test for HCV (RIBA-2) was used. In 209 donors, the presence of HCV-RNA was investigated by the PCR test. The abdominal ultrasonography was realized in 366 donors. In 269 patients liver biopsy was performed for the histopathological study. The follow-up of blood donors showed that 95.6% were repeatedly EIA-2 reagent, 94% were symptomless and denied any hepatitis history, with only 2% mentioning previous jaundice. In 47% of this population at least one risk factor has been detected for the HCV transmission, the use of intravenous drugs being the main one (27.8%). Blood transfusion was the second factor for HCV transmission (27.2%). Hepatomegaly was detected in 54% of the cases. Splenomegaly and signs of portal hypertension have seldom been found in the physical examination, indicating a low degree of hepatic compromising in HCV. Abdominal ultrasound showed alterations in 65% of the subjects, being the steatosis the most frequent (50%). In 83. 5% of the donors submitted to the liver biopsy, the histopathological exam showed the presence of chronic hepatitis, usually classified as active (89%) with mild or moderate grade in most of the cases (99.5%). The histopathological exam of the liver was normal in 1.5% of blood donors. The RIBA-2 test and the HCV-RNA investigation by PCR were positive in respectively 91.6 and 75% of the anti-HCV EIA-2 reagent donors. The HCV-RNA research was positive in 82% of the RIBA-2 positive subjects, in 37.5% of the indeterminate RIBA-2 donors and in 9% of the negative RIBA-2 donors. Chronic hepatitis has also been observed in 50% of the histopathological exams of the anti-HCV EIA-2 reagent donors which were indeterminate RIBA-2. Among 18 blood donors with minimal changes histopathological exam 11 (61%) were HCV-RNA positive. Our blood donors anti-HCV reagent generally had clinical, laboratorial and histopathological features observed in patients with chronic HCV hepatitis and a high proportion could be identified in interviews and medical evaluation realized in blood blanks. Generally, these HCV infected donors are identified and discharged only by the serological tests results.     

Transmission of Hepatitis C Virus by Anti-HCV-Negative Blood Transfusion: Case Report

Acute posttransfusion hepatitis C was reported in a recipient of 3 units of red cells. The recipient became acutely icteric 6 weeks after transfusion, and HCV infection was diagnosed. Stored serum samples of the 3 implicated donations, which were negative with ELISA-2, were retested by PCR and 3rd-generation antibody tests. One implicated donation was PCR positive, but anti-HCV negative. Both other donations were negative in all tests. The donor was recalled to the Blood Bank 13 weeks after the implicated donation and was found to be ELISA-3 plus RIBA-3 positive. Eight months after the implicated donation, the donor is still PCR and RIBA-3 positive, whereas the recipient became PCR negative but remained anti-HCV RIBA-3 positive. The case shows that blood products from donors collected during the open window period of an HCV infection can transmit HCV to recipients.     

Look-Back of Anti-HCV ELISA-Positive, HCV-RNA PCR-Negative Donors and Recipients of Their Blood Products

Background and objectives: To establish the infectivity of anti-HCV ELISA-positive, but cDNA-PCR-negative blood components transfused before the introduction of routine anti-HCV blood donor screening, we enrolled recipients of such blood products in a look-back programme. Materials and methods: The blood components were donated by (A) RIBA?-2-indeterminate and cDNA-PCR-negative donors, and (B) RIBA-2 and cDNA-PCR-negative donors. The look-back comprised 214 blood products from group A donors and 278 from group B. Results: Of 211 recipients of group A components, 66 (31.3%) were available for testing. All other recipients could not be traced, had died, or refused collaboration. Of these 66, 3 patients had independent risk factors for HCV infection and were excluded. All remaining 63 recipients were anti-HCV ELISA-negative. Of 274 recipients of group B components, 84 (30.7%) were available for testing. All others could not be traced, had died, or refused collaboration. Of these 84, six patients had an independent risk factor for HCV infection and were excluded. All remaining 78 recipients were anti-HCV ELISA-negative. None of the recipients of blood products from previous donations of anti-HCV ELISA-positive, cDNA-PCR-negative, and RIBA-2-indeterminate or negative donors were HCV-infected. Conclusions: Donors and patients with such reactivities in anti-HCV ELISA, RIBA-2, and cDNA-PCR can be assured that they are not infected with HCV. The donors involved can re-enter the donor pool, provided that future donations are anti-HCV ELISA-negative.     

Antibody Responses to Hepatitis C Virus by Second-Generation Immunoassays in a Cohort of Patients with Bleeding Disorders

The antibody responses and the prevalence patterns of antibodies to hepatitis C virus (anti-HCV) in a cohort of patients (n = 210) with bleeding disorders were studied using a first-generation and a second-generation enzyme immunoassays (EIA-1, EIA-2) as well as a second-generation recombinant immunoblot assay (RIBA-2). The anti-HCV prevalence as determined by EIA-1 and EIA-2 was 183/210 (87.1%) and 197/210 (93.8%), respectively (p = 0.0026). None of the 17 EIA-2(+)/EIA-1(-) samples was scored nonreactive by RIBA-2. At follow-up, samples of 123 patients were tested. Twenty-nine out of 111 patients reactive by EIA-1 seroreverted according to EIA-1 while the seroreversion rate with EIA-2 was 0 out of the 121 (p < 10(-8)). The anti-HCV prevalence by EIA-2 was 150/154 (97.4%) in anti-HIV-1-positive individuals and 47/56 (83.9%) in the anti-HIV-1-negative ones (p = 0.001). However, high assay signals (OD 492 nm > 2.0) were observed in 94/150 (62.7%) and 45/47 (95.7%) of the anti-HIV-1-positive and -negative patients, respectively (p = 10(-5)). The decreasing anti-HCV reactivity among anti-HIV-1-positive individuals was mainly due to diminishing c33c reactivity. Seroconversion to anti-HCV was observed in 3/7 (42.9%) cases with acute icteric non-A, non-B hepatitis by both EIA-1 and EIA-2, while the remaining 4 cases had detectable levels of anti-HCV 1-18 months before the acute episode.     

Indeterminate third-generation hepatitis C recombinant immunoblot assay and HCV RNA analysis: isolated reactivity against NS5 associated with HCV viraemia in clinical patients but not blood donors

It has previously been reported that singular reactivity against NS5 in the third generation hepatitis C virus (HCV) confirmatory recombinant immunoblot assay (RIBA-3) is not associated with detectable HCV RNA in sera. In order to investigate the significance of indeterminate HCV RIBA-3 results with particular regard to NS5, 165 sera with indeterminate RIBA-3 results were analysed for the presence of HCV RNA. Sera from blood donors constituted 58 of the 165 samples, whereas 11 were from immunocompromized patients. The remaining 96 sera were from non-immunosuppressed clinical patients. Of the 107 RIBA-3 indeterminate samples from clinical patients, 19 were HCV RNA positive (18%), with 3 of the 57 (5%) NS5 reactive samples having detectable HCV RNA. None of the 58 indeterminate samples obtained from blood donors had detectable HCV RNA. Thus, having an indeterminate RIBA-3, including singular reactivity against NS5, may be associated with the presence of detectable levels of HCV RNA in clinical patients but not necessarily in blood donors.     

High rate of infectivity and liver disease in blood donors with antibodies to hepatitis C virus.

OBJECTIVE: To determine the epidemiologic, clinical, serologic, and histologic importance of antibodies to hepatitis C virus (anti-HCV) in blood donors. DESIGN: Cross-sectional identification and prospective evaluation of seropositive donors; retrospective assessment of infectivity; and nested case-control study for risk factors. SETTING: Liver unit of a referral-based university hospital. SUBJECTS: Of 30,231 consecutive donors, 368 (1.2%) were found to be anti-HCV-reactive by enzyme-linked immunosorbent assay (ELISA). Two hundred and fifty-four of these 368 donors were evaluated for risk factors by comparison with 284 age- and sex-matched controls. Eighty-six spouses of seropositive donors were also evaluated. MEASUREMENTS AND MAIN RESULTS: Twenty-four percent of the seropositive donors had a history of percutaneous exposure to blood. This rate increased to 45% when only those donors confirmed to be anti-HCV positive by a second-generation recombinant immunoblot assay (RIBA-2) were considered. A family history of liver disease (odds ratio, 2.8; 95% Cl, 1.6 to 4.8), previous blood transfusion (odds ratio, 6.1; 95% Cl, 3 to 12.5), and a history of tattooing or intravenous drug abuse (odds ratio, 8.4; 95% Cl, 2.3 to 31) were associated with anti-HCV seropositivity. An elevated alanine aminotransferase (ALT) level was found in 58% of the seropositive donors. Of the 150 donors tested, 104 (69%; Cl, 62% to 77%) were confirmed by RIBA-2 to be anti-HCV positive. Of the 105 donors who had a biopsy, 16% had normal histologic findings, 11% had minimal changes, 21% had chronic persistent hepatitis, 45% had chronic active hepatitis, and 7% had active cirrhosis. All 77 donors with RIBA-2-confirmed seropositivity had histologic abnormalities. Of 43 donors evaluated in an infectivity study, 82% were implicated in previous HCV transmission. Only 2.3% of the spouses were anti-HCV positive. The ELISA, RIBA-2, and ALT results correlated with infectivity and abnormal histologic findings. CONCLUSIONS: In our geographic area, almost 70% of donors who are anti-HCV positive by ELISA are confirmed to be positive by RIBA-2; most of these donors appear to be chronic carriers of HCV and have substantial liver disease.     

Mother-to-infant transmission of hepatitis C virus.

OBJECTIVE: To describe the rate of perinatal transmission of hepatitis C virus (HCV). DESIGN: Follow-up study of newborn children of mothers with chronic HCV infection. SETTING: A university hospital in Sweden. PARTICIPANTS: Fourteen women with chronic HCV infection and their 21 newly born children. MAIN OUTCOME MEASURES: Detection of HCV RNA in serum by the polymerase chain reaction and detection of anti-HCV antibody by second generation assays. RESULTS: All mothers were found to be positive for anti-HCV antibody both by second-generation enzyme-linked immunosorbent assay (ELISA) and by second-generation recombinant immunoblot assay (RIBA-2); all also had detectable serum HCV RNA. Two children had long-lasting alanine aminotransferase (ALT) elevations, and one of them became HCV RNA positive. None of the other children developed biochemical hepatitis. However, two additional children had temporary viremia. Only the child with biochemical and biopsy-proven hepatitis and detectable HCV RNA in multiple blood samples actively produced anti-HCV antibody. CONCLUSIONS: Mother-to-infant transmission of HCV infection from chronically infected women without human immunodeficiency virus (HIV) infection seems to be uncommon.     

Second-Generation Hepatitis C Elisa Antibody Tests Confirmed by the Four-Antigen Recombinant Immunoblot Assay Correlate Well with Hepatitis C Viremia and Chronic Liver Disease in Swedish Blood Donors

Seventy-three Swedish blood donors (52 men, 21 women; median age 36 years) repeatedly reactive for hepatitis C antibodies (anti-HCV C-100-3) were tested with a second-generation (2^nd-gen) anti-HCV Elisa and a 4-band recombinant immunoblot assay (RIBA 2). These results were correlated to serum alanine aminotransferase (S-ALAT), liver morphology and viremia as detected by ‘nested’ polymerase chain reaction (PCR) based on primers from a 5′-noncoding sequence of the HCV genome. Thirty-five of 46 (76%) donors with positive 2^nd-gen Elisa tests confirmed by RIBA 2 were PCR positive whereof 27 had histological findings compatible with chronic persistent hepatitis (CPH) and 7 had chronic active hepatitis (CAH). Ten of 56 (18%) 2^nd-gen Elisa-positive donors were RIBA 2 negative (or indeterminate) and none of these had chronic hepatitis nor were PCR positive. Seventeen of 73 (23%) donors were 1^st-gen Elisa positive but 2^nd-gen Elisa negative. All of these were PCR negative and only 1 (6%) had chronic hepatitis (CPH). An elevated S-ALAT level (reference <0.7 μkat/1) was found in 26 2^nd-gen Elisa and RIBA 2-positive donors of which 18 had CPH and 7 had CAH and all 25 were PCR positive. A normal S-ALAT level was found in 9 of 34 (26%) donors with chronic hepatitis (all had CPH) and positive PCR. We have found that blood donors with positive 2^nd-gen anti-HCV Elisa tests confirmed by RIBA-2 and especially with a concomitant elevated S-ALAT are highly likely to be viremic as demonstrated by PCR and to have chronic hepatitis.     

High rate of nonspecific anti-hepatitis C reactivity amongst homosexual men in comparison with that found in other sexually active groups and blood donors

Abstract. Objectives . To investigate the concordance of antihepatitis C virus (anti-HCV) reactivity by a second-generation enzyme immunoassay (EIA-2) and by a four-antigen recombinant immunoblot assay (4-RIBA) in homosexual men, in comparison with that found in other sexually active groups and blood donors. Design . Prospective study. Setting . Tertiary referral centre, Seville, Spain. Subjects . A total of 1203 subjects were studied. Eight hundred and three were sexually active individuals: 547 female prostitutes, 88 heterosexual men who had frequent sexual intercourse with prostitutes, and 168 homosexual men. All of them denied blood transfusion and parenteral drug use. In addition, 400 voluntary blood donors were selected at random. Main outcome measures . All serum samples were screened for anti-HCV by EIA-2 and repeatedly reactive sera were tested by 4-RIBA. Homosexual men were also screened for anti-human immunodeficiency virus (anti-HIV), hepatitis B virus (HBV) markers and gammaglobulin concentration. Finally, serum samples from homosexual men reactive for anti-HCV by EIA-2 were analyzed for HCV-RNA by polymerase chain reaction (PCR). Results . Concordance between EIA-2 and 4-RIBA in female prostitutes (71.4%), clients of prostitutes (75.0%), and blood donors (83.3%) was significantly higher than in homosexual men (38.8%) (P < 0.04). In this collective the concordance between 4-RIBA and PCR was 85.7% for positive cases and 88.8% for negative ones, and EIA-2 ratios in reactive sera were significantly higher in 4-RIBA confirmed cases (P < 0.0001). No correlation between false positive EIA-2 results and presence of HIV infection, HBV markers or hypergammaglobulinaemia was found in homosexual men by univariate analysis. Conclusions . There is a high level of non-specific anti-HCV reactivity by EIA-2 amongst homosexual men in comparison with that found in other sexually active groups and blood donors. The true prevalence of HCV infection amongst homosexual men could be even lower than previously described.     

Epidemiology,serological markers,and hepatic disease of anti-HCV ELISA-2-positive blood donors

The epidemiology associated with hepatitis C virus (HCV) infection, serologic reactivity, and hepatic disease related to anti-HCV-positive donors of Granada were researched. From 1990 through 1993, medical and epidemiological information and anti-HCV and HCV RNA testing were evaluated in 46,741 blood donors. Serum samples were obtained for anti-HCV ELISA and RIBA and HCV RNA determination. A liver biopsy was conducted in all anti-HCV positives by confirmatory second-generation RIBA to analyze the hepatic lesion and the presence of HCV RNA. The anti-HCV prevalence was 1.12%. A total of 228 anti-HCV second-generation ELISA positive blood donors were analyzed. Intrafamiliar transmission rate was 1.7%. Transfusion and intravenous drug abuse (IVDA) antecedents were associated with a higher risk of seroconversion. A RIBA-positive result was related to high second- and third-generation ELISA ratios (90%), HCV RNA positivity (89%), and elevated alanine aminotransferase (ALT) levels (88%). Approximately 50% of donors with normal ALT levels had high ELISA ratios and second-generation RIBA and HCV RNA positive results. Of the second-generation RIBA indeterminate results, 42% and 82% of the c22 and 33% and 100% of the c100 reactivities were third-generation RIBA and HCV RNA positive, respectively. Liver biopsy was conducted in 85 donors, 74% of whom had a chronic hepatitis and 83% had detectable HCV RNA levels. Chronic hepatitis was diagnosed in 88% vs 43% of donors with elevated and normal alanine aminotransferase levels, respectively. ELISA and confirmatory HCV RNA determinations should be routinely employed in donor screening. A liver biopsy should be conducted in patients with elevated ALT levels and normal ALT levels when viremic.     

Hepatitis C virus antibodies, viral RNA and genotypes in sera from patients on maintenance haemodialysis

SUMMARY. Patients on maintenance haemodialysis in four dialysis centres were tested for markers of hepatitis C virus (HCV) infection. Antibody to HCV (anti-HCV) was detected by the second-generation enzyme immunoassay in 142 (26%) of the 543 patients and HCV RNA in 117 (22%) of whom four were without detectable anti-HCV in serum. Seventy-seven (66%) were infected with HCV of genotype II/1b, 31 (27%) with genotype III/2a and eight (7%) with genotype IV/2b. in a distribution similar to that in blood donors who carried HCV asymptomatically. Haemodialysis patients had high HCV RNA titres comparable to those of patients with chronic hepatitis C. HCV RNA was detected in 96 (26%) of the 365 patients with a history of transfusion more frequently than in 21 (12%) of the 178 without previous transfusion ( P <0.001). In transfused patients, frequencies of anti-HCV and HCV RNA increased in parallel with the duration of haemodialysis. The frequency of anti-HCV in non-transfused patients, however, did not change appreciably with the duration of haemodialysis up to 22 years. The patients with anti-HCV had a higher frequency of HCV RNA in serum than symptom-free blood donors with anti-HCV (113/142 or 80% vs 109/166 or 66% P <0.01) and the patients with HCV RNA had a lower frequency of elevated aminotransferase levels than blood donors with HCV RNA (5/113 or 4% vs 27/109 or 25%, P <0.00l). These results indicate that transfusion is a significant cause of HCV infection in patients on maintenance haemodialysis, and that these patients are prone to establish the HCV carrier state after infection.     

Marrow transplantation from hepatitis C virus seropositive donors: transmission rate and clinical course

Bone marrow transplant recipients are at risk for acquiring hepatitis C infection from the donated marrow. Twelve patients who were hepatitis C virus (HCV) RNA-negative pretransplant received marrow from anti-HCV seropositive donors. HCV RNA was present in the sera of seven of these donors. After transplant, serial serum specimens were obtained from all marrow recipients for determination of HCV RNA and aminotransferase levels. All seven recipients of marrow from HCV RNA-positive donors were HCV RNA-positive after marrow infusion; none cleared virus from the serum. All five recipients of marrow from anti-HCV seropositive, HCV RNA-negative donors remained free of HCV RNA in serum up to day 100. Abnormal serum aminotransferases were common in both HCV RNA- negative and HCV RNA-positive marrow recipients. One HCV-infected recipient developed marked elevation in aminotransferases after immunosuppressive drugs were stopped. We conclude that the presence of HCV RNA in the serum of marrow donors is an accurate predictor of HCV infection in marrow recipients. The acute infection was subclinical in all patients. The long-term risk of chronic hepatitis C virus infection in these patients remains to be determined.     

Evaluation of Third-Generation Screening and Confirmatory Assays for HCV Antibodies

A third-generation (gen.) screening and immunoblot assay (Ortho EIA-3.0; Chiron RIBA-3 prototype), using antigens derived from the capsid and different nonstructural regions (NS3, NS4 and NS5) of the hepatitis C virus viral genome, were evaluated in comparison with the corresponding second-gen. assays (Ortho EIA-2.0; revised Ortho EIA-2.5; Chiron RIBA-2). In 203 depository sera of blood donors, positive in EIA-2.0, specificity of the screening assays was improved as shown by an increase in positive predictive value for viral carrier state from 0.23 (EIA-2.0) to 0.37 (EIA-2.5) and 0.52 (EIA-3.0). Comparing the confirmation patterns on RIBA-2 and RIBA-3, this amelioration was mainly due to the specific elimination of false-positive c22-3 and c100-3 reactions. Antibody response to the newly added NS5 antigen was not as prevalent as to the other antigens and had only a minor influence in sample allocation. In contrast, screening of 1,560 volunteer blood donors and 47 hemodialysis patients revealed 3 additional positive sera, only reacting with the NS5 antigen. However none of these isolated NS5 reactions could be confirmed on synthetic peptides [INNO-LIA: NS5(p)] and none was PCR positive. A documented seroconversion, detected earlier with EIA-3.0, was related to a better immunological response to the NS3 antigen and not to the additional NS5. From this pilot study third-gen. assays appeared extremely useful in the reevaluation of HCV-seropositive depository sera. However the additional value of the NS5 antigen in blood donor screening is still hypothetical and remains to be established in larger screening studies.     

Sensitivity and Specificity of Three Third-Generation Anti-Hepatitis C Virus ELISAs

Three commercially available 3rd-generation anti-HCV ELISAs (Abbott, Murex and Ortho) were evaluated in various serum panels: (A) blood donor samples (n = 403) with 1st- or 2nd-generation anti-HCV ELISA (various manufacturers) positive test results; (B) non-A, non-B hepatitis patients (n = 212); (C) multitransfused patients (n = 253); (D) serial dilutions of HCV confirmed (RIBA and PCR) positive blood donors (n = 24), and (E) first-time blood donors (n = 1,055). All samples of panels A, B and C were tested in PCR and RIBA-2. In panels A, B and C, 398 samples were HCV PCR positive: all were detected by Abbott and Ortho, and 397 (99.7%) by Murex. The sample missed by the Murex ELISA showed an isolated anti-C33c reactivity in RIBA-2. In panels A–C, 442 samples were RIBA-2 positive and all were detected by the 3 tests. With Probit analysis on results of panel D, no significant difference in sensitivity was observed between the 3 evaluated ELISAs. Specificities of Abbott, Murex and Ortho in 1,055 blood donors were 99.7, 99.3 and 99.9%, respectively (NS, χ²). We conclude that the sensitivity and specificity of the 3 ELISAs are comparable although the C33c antigen in the Murex VK47 test should be improved.     

Hepatitis C virus RNA and liver histology in blood donors reactive to a single antigen by second-generation recombinant immunoblot assay

The clinical significance of single band reactivity (indeterminate pattern) at anti-hepatitis C virus (HCV) second-generation recombinant immunoblot assay (RIBA-2) was investigated in symptomless subjects with normal liver function tests to obtain data for their counseling and clinical management. Serum and hepatic HCV RNA were determined by the nested polymerase chain reaction, and liver histology was evaluated in 40 symptomless blood donors with stable indeterminate RIBA-2 pattern, including 38 reactive to c22-3. All but one had normal alanine aminotransferase (ALT) levels. Two new immunoblot tests, RIBA-3 and INNO-LIA HCV Ab III (LIA-III), which incorporate additional HCV antigens, were also done to assess whether they could identify the viremic subjects. Ten cases (25%, confidence interval 12 to 38) were HCV RNA positive. Three of the HCV RNA-positive and none of the HCV RNA-negative subjects had chronic hepatitis. RIBA-2 strong intensity of reaction (score >2+) was observed in all the HCV RNA-positive and in 12 HCV RNA-negative subjects. RIBA-3 and LIA-III gave positive results in 9 of 10 and 10 of 10 HCV RNApositive, but also in 8 of 30 and 24 of 30 HCV RNAnegative subjects. A c-22-3 reactivity score of 4+ by RIBA-3 and E2/NS1 reactivity by LIA-III were both strongly associated with HCV RNA (P < .001). Based on relatively high prevalence of chronic hepatitis in our series (30%), apparently healthy subjects with stable indeterminate RIBA-2 pattern and HCV RNA positivity should be considered for liver biopsy independently of ALT profile. Reactivity to particular HCV antigens by third-generation tests helped to identify the subjects with current infection.     

The accuracy of SM-HCV rapid test for the detection of antibody to hepatitis C virus

OBJECTIVE: Conventional tests for antibody to hepatitis C virus (HCV) require considerable time before results are available. The aim of this study is to examine the accuracy of a new quick test (SM-HCV Rapid Test) for the detection of antibody to hepatitis C virus with reference to the well-established third generation enzyme immunoblot assay (EIA-3; Abbott Laboratories, Chicago, IL). METHODS: A total of 290 subjects (100 patients with chronic hepatitis C infections, 95 patients with other chronic liver diseases, 95 healthy subjects) were recruited. Thirty microliters of serum was tested for anti-HCV by SM-HCV Rapid Test according to the manufacturer's instruction. Liver function tests and serum HCV RNA by polymerase chain reaction (PCR) were measured. RESULTS: In the 100 patients positive for anti-HCV by EIA-3, 98 of these patients were also positive for anti-HCV by SM-HCV Rapid Test. In the 95 patients with other chronic liver diseases, 94 samples were negative for anti-HCV by both EIA-3 and SM-HCV Rapid Test. The remaining one patient was positive for anti-HCV by the EIA-3 but negative by the SM-HCV Rapid Test. In the 95 controls, which were negative for anti-HCV by EIA-3, all were also negative for anti-HCV by SM-HCV Rapid Test and HCV RNA by PCR. Using EIA-3 as the gold standard screening test for anti-HCV, the sensitivity and the specificity of SM-HCV Rapid Test were 98% and 100%, respectively. The positive predictive value and negative predictive value of SM-HCV Rapid Test were 100% and 97.9%, respectively. CONCLUSIONS: SM-HCV Rapid Test is a reliable test with high sensitivity and specificity. The anti-HCV result can be available within a very short period of time. It is a useful screening test for anti-HCV.