Disease progression in Chinese chronic hepatitis C patients with persistently normal alanine aminotransaminase levels.

BACKGROUND: Although chronic hepatitis C virus-infected patients with persistently normal alanine aminotransaminase levels usually have mild liver disease, disease progression can still occur. However, it is uncertain which group of patients is at risk of disease progression. AIM: To examine the severity of liver disease on liver biopsy in Chinese patients with persistently normal alanine aminotransaminase levels, and their disease progression over time. METHODS: Eighty-two patients with persistently normal alanine aminotransaminase levels were followed up longitudinally. The median time of follow-up was 8.1 years. Forty-seven of the 82 patients (57.3%) had a second liver biopsy. RESULTS: At the time of analysis, six of the 82 patients (7.3%) developed decompensated liver cirrhosis. Patients with an initial fibrosis stage F2 or F3 [6/23 (26.1%) vs. 0/59 (0%), P < 0.0001] or inflammatory grade A2 or A3 [5/40 (12.5%) vs. 1/42 (2.4%), P = 0.04] were more likely to develop decompensated liver cirrhosis. On multivariate analysis, initial fibrosis stage F2 or F3 was independently associated with progression to decompensated liver cirrhosis (relative risk 2.3, 95% confidence interval 0.03-2.5, P = 0.02). CONCLUSION: Chinese chronic hepatitis C virus patients with persistently normal alanine aminotransaminase levels with moderate to severe fibrosis at initial evaluation are more likely to develop decompensated liver cirrhosis.

48 weeks pegylated interferon alpha-2a is superior to 24 weeks of pegylated interferon alpha-2b in achieving hepatitis B e antigen seroconversion in chronic hepatitis B infection.

BACKGROUND/AIM: Although 48-week therapy with pegylated-interferons has been shown to be effective for the treatment of chronic hepatitis B virus infection, the efficacy of a shorter duration of therapy with pegylated interferons is unknown. METHOD: We reviewed 53 hepatitis B e antigen positive Chinese patients treated with 48 weeks of pegylated interferon alpha-2a or 24 weeks of pegylated interferon alpha-2b. Sustained virological response was defined as hepatitis B e antigen seroconversion and hepatitis B virus DNA <10(5) copies/mL at week 72. RESULTS: Twenty-nine patients were treated with 48 weeks of pegylated-interferon-alpha-2a and 24 patients with 24 weeks of pegylated-interferon-alpha-2b. At the end-of-therapy, hepatitis B e antigen seroconversion and hepatitis B virus DNA <10(5) copies/mL were similar between the two groups of patients [9/29 (31.0%) vs. 2/24 (8.3%), respectively, P = 0.09]. At week 72, 10 of the 29 patients (34.5%) treated with 48 weeks of pegylated-interferon-alpha-2a compared with two of the 24 patients (8.3%) treated with 24 weeks of pegylated-interferon-alpha-2b had sustained virological response (P = 0.04). By logistic analysis, 48 weeks of pegylated-interferon-alpha-2a was independently associated with sustained virological response (P = 0.04 adjusted hazards-ratio 9.37). CONCLUSION: Further studies are required to determine the optimal duration of therapy with pegylated interferons in chronic hepatitis B.

Trends in the prevalence of peptic ulcer disease and Helicobacter pylori infection in family physician-referred uninvestigated dyspeptic patients in Hong Kong.

BACKGROUND: Peptic ulcer disease is mainly caused by Helicobacter pylori infection and the use of non-steroidal anti-inflammatory drugs. AIM: To investigate the trends in the prevalence of peptic ulcer disease, H. pylori infection and non-steroidal anti-inflammatory drug use in uninvestigated dyspeptic patients over recent years in Hong Kong. METHODS: Data from consecutive patients with uninvestigated dyspeptic symptoms referred by family physicians for open access upper endoscopy during 1997 and 2003 were analysed in relation to peptic ulcer disease, H. pylori infection and non-steroidal anti-inflammatory drug use. RESULTS: Among 2700 patients included, 405 (15%) had peptic ulcer disease and 14 (0.5%) had gastric cancer. There was a reduced trend from 1997 to 2003 in the prevalence of peptic ulcer disease (17, 20, 14, 16, 13, 14 and 14%, respectively, chi2 = 5.80, P = 0.016) (mainly because of decrease in duodenal ulcers), H. pylori infection (44, 50, 49, 44, 40, 40, 36 and 43%, respectively, chi2 = 13.55, P < 0.001) and non-steroidal anti-inflammatory drug use (13, 5, 5, 6, 3, 4, 4 and 5% respectively, chi2 = 13.61, P < 0.001). The prevalence of peptic ulcer disease, H. pylori infection and non-steroidal anti-inflammatory drug use between 2001 and 2003 were significantly lower than that between 1997 and 2000 (17% vs. 13%, OR = 0.78, 95% CI: 0.63-0.96, P = 0.020 for peptic ulcer disease; 47% vs. 39%, OR =0.72, 95% CI: 0.60-0.86, P < 0.001 for H. pylori infection; and 6% vs. 4%, OR = 0.56, 95% CI: 0.39-0.82, P = 0.002 for non-steroidal anti-inflammatory drug use). H. pylori infection was associated with both duodenal ulcer (OR = 15.87, 95% CI: 10.60-23.76, P < 0.001) and gastric ulcer (OR = 3.12, 95% CI: 2.15-4.53, P < 0.001) whereas non-steroidal anti-inflammatory drug use was only associated with gastric ulcer (OR = 2.97, 95% CI: 1.70-5.20, P < 0.001). CONCLUSIONS: The prevalence of peptic ulcer disease, mainly duodenal ulcers, was reduced in association with a decreasing trend in the prevalence of H. pylori infection and non-steroidal anti-inflammatory drug use from 1997 to 2003.

Does withholding aspirin for one week reduce the risk of post-sphincterotomy bleeding?

BACKGROUND: Complications of endoscopic sphincterotomy are closely related to the endoscopic technique. To date, there have been no studies to indicate that aspirin increases the risk of bleeding after endoscopic sphincterotomy. AIM: To compare the incidence of post-sphincterotomy bleeding in patients with and without prior aspirin therapy. METHODS: Eight hundred and four patients were recruited into this retrospective study: 124 patients continued to take aspirin until the day of sphincterotomy (Group 1), 116 patients had their aspirin discontinued for 1 week before sphincterotomy (Group 2) and 564 patients had never taken aspirin (Group 3). The primary outcome analysed was the incidence of post-sphincterotomy bleeding. RESULTS: Sixty-seven patients (8.3%) developed post-sphincterotomy bleeding. The incidences of post-sphincterotomy bleeding in Groups 1, 2 and 3 were 9.7%, 9.5% and 3.9%, respectively. Group 1 showed significantly increased post-sphincterotomy bleeding when compared with Group 3 (P=0.01), and the risk was also significantly increased when Group 2 was compared with Group 3 (P=0.01). However, there was no significant difference in post-sphincterotomy bleeding between Groups 1 and 2 (P=0.96). CONCLUSIONS: Aspirin therapy increased the risk of post-sphincterotomy bleeding. Withholding aspirin for 1 week before endoscopic sphincterotomy did not seem to decrease the risk of post-sphincterotomy bleeding.

Retained common bile duct stones: a comparison between biliary stenting and complete clearance of stones by electrohydraulic lithotripsy.

BACKGROUND: There is some uncertainty as to whether high-risk patients with difficult common bile duct stones should be subjected to a further endoscopic procedure for the complete removal of stones by electrohydraulic lithotripsy or whether permanent biliary stenting should be performed. AIM: To compare the outcome of permanent biliary stenting with electrohydraulic lithotripsy in this group of patients. METHODS: In a prospective study, 36 patients with difficult common bile duct stones were investigated: 19 underwent double pigtail insertion (stent group), whereas 17 underwent complete clearance of stones (electrohydraulic lithotripsy). RESULTS: In the electrohydraulic lithotripsy group, successful stone clearance was achieved in 76.5%, whereas, in the stent group, the success of stenting was 94.7%. A significant difference was detected in the actuarial incidence of recurrent acute cholangitis when the electrohydraulic lithotripsy group was compared with the stent group [one patient (7.7%) vs. 12 patients (63.2%), respectively; P = 0.002, log rank test]. A significant difference was detected in the actuarial frequency of mortality between the electrohydraulic lithotripsy and stent groups [seven patients (41.2%) vs. 14 patients (73.7%), respectively; P = 0.01, log rank test]. CONCLUSIONS: The removal of difficult common bile duct stones by electrohydraulic lithotripsy and further endoscopic retrograde cholangiopancreatography has a high success rate and a low complication rate even in the elderly.

Acute cholangitis--predictive factors for emergency ERCP.

BACKGROUND: Acute cholangitis varies in severity from a mild form to severe cases which require urgent biliary decompression. AIM: This study was undertaken in order to develop a prognostic scoring system that can be used to predict which patients are likely to require emergency endoscopic retrograde cholangiopancreatogram (ERCP) upon admission. METHODS: This is a prospective study of 142 consecutive patients with acute cholangitis. Emergency ERCP was performed in patients who did not respond to medical therapy. RESULTS: Thirty-one patients (21.8%) required emergency ERCP. A maximum heart rate of more than 100/min, albumin of less than 30 g/L, bilirubin of more than 50 micromol/L and prothrombin time of more than 14 s on admission were associated with failure of medical treatment and the need for emergency ERCP (P=0.001, < 0.001, 0.006 and 0.004, respectively). By using these four factors in a scoring system, 50.7% of those with a score of one or more required emergency ERCP compared with 1.5% of those with none of the four risk factors (P < 0.001). This scoring system has a sensitivity of 96.8% and a specificity of 59.6%. CONCLUSIONS: As patients with severe acute cholangitis show a higher mortality, we recommend that emergency ERCP be performed in patients with one or more of the four prognostic factors.

Outcome of emergency ERCP for acute cholangitis in patients 90 years of age and older.

BACKGROUND: An increasing proportion of the general population across the Western World now survives to an advanced age. However, there is limited data on the outcome of therapeutic endoscopic retrograde cholangiopancreatography in patients above 90 years of age with severe acute cholangitis. AIM: To determine the relative frequency of postendoscopic retrograde cholangiopancreatography complication in this group of patients. METHODS: The postendoscopic retrograde cholangiopancreatography complications related outcome of 64 patients aged 90 years and above (Group 1) with severe acute cholangitis were retrospectively compared with 165 patients under the age of 90 years (Group 2). RESULTS: The postendoscopic retrograde cholangiopancreatography complication rate was 4.7% (three patients) in Group 1 and 7.3% (12 patients) in Group 2. There was no significant difference in the postendoscopic retrograde cholangiopancreatography complication rate between the two groups (P = 0.567). The relative frequency of 30-day mortality was 7.8% (five patients) in Group 1 and 4.2% (seven patients) in Group 2 (P = 0.227). CONCLUSION: Urgent biliary decompression with endoscopic retrograde cholangiopancreatography in patients 90 years of age and older with severe acute cholangitis is a safe and effective procedure in the hands of highly skilled endoscopists and is not associated with increased morbidity or mortality even in this group of high risk patients.

Long-term prospective follow-up of endoscopic oesophagitis in southern Chinese--prevalence and spectrum of the disease.

AIMS: To study the prevalence, clinical characteristics and long-term outcome of oesophagitis in Chinese patients. METHODS: Clinical and endoscopic data were collected prospectively from consecutive patients who underwent upper endoscopy between 1997 and 2001. Patients with endoscopic oesophagitis were graded according to the Los Angeles system and analysed according to their clinical presentation, endoscopic details, Helicobacter pylori status, non-steroidal anti-inflammatory drug history, co-morbidity and mortality. RESULTS: A total of 22,628 upper endoscopies were performed in 16,606 patients. Of these, 631 (3.8%) had endoscopic oesophagitis, 14 had benign oesophageal stricture (0.08%) and 10 had Barrett's oesophagus (0.06%). Most patients (94%) had either Los Angeles grade A or grade B oesophagitis. Patients who died during follow-up had a significantly higher incidence of co-morbid illness (100% vs. 63%, P < 0.001). By Cox regression analysis, the presence of gastrointestinal bleeding (P = 0.008), advanced age (P = 0.004) and the use of Ryle's tube (P = 0.043) were identified to be independent factors associated with mortality. CONCLUSIONS: Complicated gastro-oesophageal reflux disease is uncommon in the Asian population. Advanced age, use of Ryle's tube and the presence of gastrointestinal bleeding are associated with a poor long-term outcome, which is a reflection of the severe underlying co-morbidity.

Rabeprazole-based 3-day and 7-day triple therapy vs. omeprazole-based 7-day triple therapy for the treatment of Helicobacter pylori infection.

BACKGROUND: Rabeprazole is a new proton pump inhibitor with more potent acid suppressive and anti-Helicobacter effects. AIM: To compare two different regimens of rabeprazole-based triple therapy vs. 7-day omeprazole-based triple therapy for the eradication of Helicobacter pylori infection. METHOD: Patients with proven H. pylori infection were randomized to receive: (i) 7-day rabeprazole, 10 mg, amoxicillin, 1000 mg, and clarithromycin, 500 mg, all twice daily; (ii) 3-day rabeprazole, 20 mg, amoxicillin, 1000 mg, and clarithromycin, 500 mg, all twice daily; or (iii) 7-day omeprazole, 20 mg, amoxicillin, 1000 mg, and clarithromycin, 500 mg, all twice daily. Endoscopy (CLO test, histology) was performed before randomization and 6 weeks after drug treatment. RESULTS: One hundred and seventy-three patients were randomized. H. pylori eradication rates (intention-to-treat, n=173/per protocol, n=167) were 88%/91% for 7-day rabeprazole-based therapy, 72%/72% for 3-day rabeprazole-based therapy and 82%/89% for 7-day omeprazole-based therapy, respectively. The per protocol eradication rate was significantly better in the 7-day rabeprazole-based therapy and 7-day omeprazole-based therapy groups when compared to the 3-day rabeprazole-based therapy group (P=0.01 and P=0.04, respectively). Compliance was excellent and all three regimens were well tolerated. CONCLUSIONS: The efficacy of seven-day rabeprazole-based triple therapy is similar to 7-day omeprazole-based triple therapy for the eradication of H. pylori infection.

Low molecular weight heparin-induced liver toxicity.

The authors report two cases of hepatotoxicity induced by low molecular weight heparin. A 26-year-old woman and a 33-year-old man were treated with low molecular weight heparin for pulmonary embolism and cerebral infarction, respectively. They both developed derangement in liver function tests a few days after commencement of the low molecular weight heparin. The derangement in liver function tests was associated with a decreased serum complement 3 activity. Their liver functions recovered over a period of 2 to 3 months after low molecular weight heparin was stopped. Liver biopsy in the woman demonstrated balloon degeneration with scattered foci of hepatocytic necrosis, suggesting a complement-mediated hepatocellular damage.

Progressive demyelinating neuropathy after initiation of continuous ambulatory peritoneal dialysis--report of two cases.

We report on two patients who developed rapidly progressive demyelinating neuropathy within 6 to 10 weeks after the initiation of continuous ambulatory peritoneal dialysis. The neuropathy in one patient resolved after kidney transplantation while that of the other patient improved with immunosuppressive therapy. The close temporal relationship between the initiation of peritoneal dialysis and the onset of neuropathy suggests that these two events may be causally related.

Intestinal lymphangiectasia associated with recurrence of histiocytosis X.

Intestinal lymphangiectasia may occur as a primary congenital disorder or a secondary disorder. Secondary lymphangiectasia could be associated with diseases such as abdominal carcinoma, retroperitoneal fibrosis or chronic pancreatitis. This is the first reported case of intestinal lymphangiectasia associated with recurrent histiocytosis X. This case report illustrates the need for more prospective, well-designed studies to determine the natural history and outcome of intestinal lymphangiectasia in the duodenum. Hopefully, these studies will also help clinicians identify which group of patients with intestinal lymphangiectasia in the duodenum is more likely to have a secondary cause.

Resolution of eosinophilic gastroenteritis after resection of uterine leiomyomas.

Eosinophilic gastrointestinal disorders (EGIDs) primarily affect the gastrointestinal tract. EGIDs have a broad spectrum of presentations, characterised by prominent eosinophilic infiltration through a variable depth in the gastrointestinal tract in the absence of a known cause for eosinophilia. EGIDs include eosinophilic oesophagitis, eosinophilic gastritis, eosinophilic gastroenteritis, eosinophilic enteritis and eosinophilic colitis. Here, we report EGID in a woman who had co-existing uterine leiomyomas. Her EGID resolved after resection of the leiomyomas. She remained asymptomatic on follow-up 13 months after the myomectomy, with resolution of the eosinophilic infiltrate in the gastrointestinal tract.

A randomised double-blind controlled study evaluating the hypothermic effect of 150 microg morphine during spinal anaesthesia for Caesarean section.

We studied the hypothermic effect of adding 150 microg morphine during spinal anaesthesia in 60 parturients scheduled for elective caesarean section. All the parturients received intrathecal injection of a solution containing 150 mug morphine or normal saline in addition to 10-12 mg hyperbaric bupivacaine 0.5%. In both groups, a significant decrease in body temperature was noted. There was no difference in the area under the curve for temperature against time for the two groups; however, the maximum decrease in temperature from baseline was significantly larger after morphine than after saline injection (mean (SD) 1.11 (0.61) degrees C vs 0.76 (0.39) degrees C, respectively; p = 0.01) and the time to nadir temperature was significantly longer (59.5 (17.6) min vs 50.4 (15.9) min, respectively; p = 0.047). The lowest temperature observed in the morphine group was 34.3 degrees C. We conclude that intrathecal injection of 150 microg morphine intensified the intra-operative hypothermic effect of bupivacaine spinal anaesthesia for caesarean section.

Natural history of patients with recurrent chronic hepatitis C virus and occult hepatitis B co-infection after liver transplantation.

It is uncertain whether occult hepatitis B virus co-infection will hasten progressive liver disease in chronic hepatitis C patients after liver transplantation. This study evaluated fibrosis progression and severe fibrosis in 118 consecutive hepatitis B surface antigen-negative patients with virological and histological evidence of recurrent chronic hepatitis C infection co-infected with occult hepatitis B virus after liver transplantation. HBV DNA was detected from serum at the time of recurrent chronic hepatitis C infection by polymerase chain reaction. Each subject underwent a repeat liver biopsy 5 years post-liver transplantation. Occult hepatitis B virus co-infection was present in 41 of the 118 (34.7%) patients. At 5 years post-liver transplantation, 13 of the 41 occult hepatitis B virus co-infected patients compared with 16 of the 77 patients without occult hepatitis B virus co-infection developed fibrosis progression (31.7% vs. 20.8%, respectively, p = 0.39). Eight of 41 the occult hepatitis B virus co-infected patients compared with 13 of the 77 patients without occult hepatitis B virus co-infection had severe fibrosis (19.5% vs. 16.9%, respectively, p = 0.97). In conclusion, occult hepatitis B virus co-infection in patients with recurrent chronic hepatitis C infection was not associated with accelerated fibrosis progression or severe fibrosis after liver transplantation.

Pharmacokinetics of pitavastatin in subjects with Child-Pugh A and B cirrhosis.

AIM: Lipid lowering therapy with 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors is increasingly used for the prevention of cardiovascular events, but they should be used with caution in patients with impaired liver function. We therefore studied the pharmacokinetics of pitavastatin in patients with liver cirrhosis. METHODS: Plasma concentrations of pitavastatin were determined after administration of 2 mg single-dose pitavastatin to 12 male patients with liver cirrhosis (six Child-Pugh grade A and six grade B). These results were compared with the single-dose pharmacokinetic results obtained from six male volunteers without liver disease. RESULTS: Administration of 2 mg single-dose pitavastatin to patients with Child-Pugh grade A and grade B cirrhosis resulted in a 1.19- and 2.47-fold increase in Cmax and 1.27- and 3.64-fold increase in AUCt, respectively, when compared with normal subjects. The geomean Cmax of pitavastatin was 59.5 ng ml(-1), 70.7 ng ml(-1) and 147.1 ng ml(-1) in the control, Child-Pugh grade A and Child-Pugh grade B groups, respectively. The geomean AUCt of pitavastatin in the three groups was 121.2 ng h(-1) ml(-1), 154.2 ng h(-1) ml(-1) and 441.7 ng h(-1) ml(-1), respectively. The geomean Cmax of pitavastatin lactone was 20.3 ng ml(-1), 19.1 ng ml(-1) and 9.9 ng ml(-1) in the control, Child-Pugh grade A and grade B groups, respectively. The AUCt of pitavastatin lactone was 120.2 h(-1) ml(-1), 108.8 h(-1) ml(-1) and 87.5 h(-1) ml(-1), respectively. CONCLUSION: The plasma concentration of pitavastatin is increased in patients with liver cirrhosis. In such patients, caution is required, although dose reduction may not be necessary in Child-Pugh A cirrhosis.

Hepatitis B reactivation after withdrawal of pre-emptive lamivudine in patients with haematological malignancy on completion of cytotoxic chemotherapy.

BACKGROUND: The hepatic outcome of hepatitis B surface antigen (HBsAg) positive patients undergoing chemotherapy after withdrawal of pre-emptive lamivudine is unknown. AIMS: To examine the occurrence of hepatitis B virus (HBV) reactivation after withdrawal of pre-emptive lamivudine. METHODS: Pre-emptive lamivudine was started one week before initiation of chemotherapy in 46 consecutive HBsAg positive patients and continued for the entire duration of chemotherapy. Pre-emptive lamivudine was stopped at a median 3.1 (range 3.0-3.4) months after completion of chemotherapy. Patients were longitudinally followed up after withdrawal of pre-emptive lamivudine. RESULTS: Median time of follow up after withdrawal of lamivudine was 25.7 (range 5.7-75.7) months. Eleven of the 46 patients (23.9%) developed HBV reactivation after withdrawal of pre-emptive lamivudine. Eight of the 16 patients with high pre-chemotherapy HBV DNA (> or =10(4) copies/ml) compared with three of the 30 patients with low pre-chemotherapy HBV DNA (<10(4) copies/ml) developed HBV reactivation (50.0% v 10.0%, respectively; p<0.001). Hepatitis B e antigen positive patients were also more likely to develop HBV reactivation (5/11 (45.5%) v 6/35 (17.1%), respectively; p = 0.041). A high pre-chemotherapy HBV DNA (> or =10(4) copies/ml) was the most important risk factor for HBV reactivation after withdrawal of pre-emptive lamivudine on Cox proportional hazards analysis (relative risk 16.13, (95% confidence interval 2.99-87.01; p = 0.001). CONCLUSIONS: HBV reactivation is more likely to occur in patients with high pre-chemotherapy HBV DNA after withdrawal of pre-emptive lamivudine. A more prolonged course of antiviral therapy may be necessary in these patients after completion of chemotherapy in order to reduce post-chemotherapy HBV reactivation.

Outcomes of interferon alpha and ribavirin treatment for chronic hepatitis C in patients with normal serum aminotransaminases.

INTRODUCTION: Information on treatment outcomes with interferon plus ribavirin combination therapy in chronic hepatitis C patients with normal alanine aminotransaminase (ALT) levels is limited. AIM: The aims of this study were to assess outcomes of treatment with interferon plus ribavirin in patients with normal ALT levels (normal ALT group, n=52) compared with those with elevated ALT levels (raised ALT group, n=53), and to document the rate at which patients with normal ALT levels have an apparent worsening of disease, as shown by increases in ALT levels. RESULTS: At the end of treatment (week 48), 31 patients (59.6%) in the normal ALT group and 30 patients (56.6%) in the raised ALT group had undetectable hepatitis C virus (HCV) RNA (p=0.75). A sustained virological response (SVR) was achieved in 20 patients (38.5%) in the normal ALT group and in 21 patients (39.6%) in the raised ALT group (p=0.90). Patients were subsequently followed up for a median of 29.8 (interquartile range 25th-75th percentile (IQR) 20.8-36.2) months in the normal ALT group and for a median of 26.1 (IQR 17.7-36.3) months in the raised group (p=0.20) after week 72 of treatment. Among patients without SVR in the normal ALT group, only three patients (9.4%) developed persistently raised ALT levels following therapy. CONCLUSIONS: Combination therapy with interferon plus ribavirin is associated with a similar SVR in patients with normal ALT levels compared with those with elevated ALT levels. In patients with normal ALT levels, virological non-response to therapy results in new elevations in serum ALT levels in a small minority only.

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.