Combined Use of Malaria Antigen and Antibody Enzyme-Linked Immunosorbent Assay for Blood Screening of Plasmodium vivax in the Republic of Korea.

OBJECTIVE: To evaluate the clinical sensitivity and specificity of the newly developed Genedia malaria antigen enzyme-linked immunosorbent assay (ELISA) test and to evaluate the diagnostic efficiency of the combined use of the Genedia malaria antigen and antibody ELISA tests to detect Plasmodium vivax in blood samples. MATERIALS AND METHODS: In all, 1,070 samples were analyzed: 300 P. vivax-infected patients, 41 samples from posttreatment patients upon follow-up and 729 healthy volunteers. The Genedia malaria antigen ELISA test and the Genedia malaria antibody ELISA 2.0 test were evaluated and compared to polymerase chain reaction and microscopy. RESULTS: The Genedia malaria antigen ELISA test had a clinical sensitivity of 94.7% (284/300) and a clinical specificity of 99.3% (724/729). The Genedia malaria antibody ELISA 2.0 test had a clinical sensitivity of 94.0% (282/300) and a clinical specificity of 98.4% (717/729). The Genedia malaria antigen ELISA test was able to detect 13 confirmed P. vivax cases without antibodies against P. vivax, whereas the Genedia malaria antibody ELISA 2.0 test detected 11 confirmed P. vivax cases nonreactive to the Genedia malaria antigen ELISA test, and 25 cases from 41 follow-up samples nonreactive in the Genedia malaria antigen ELISA test. The combined Genedia malaria antigen and antibody ELISA 2.0 tests had a clinical sensitivity of 98.3% (295/300) and a clinical specificity of 97.9% (714/729). CONCLUSION: The combination of antigen and antibody ELISAs improved the diagnostic sensitivity in P. vivax-confirmed cases in the Republic of Korea.

Prevalence of hepatitis C virus infections and distribution of hepatitis C virus genotypes among Korean blood donors.

BACKGROUND: Hepatitis C virus (HCV) remains a worldwide health-care burden. Prevalence rates vary and the distribution of genotypes depends on geographical location. Here, the recent prevalence of HCV infections and distribution of HCV genotypes among Korean blood donors were studied. METHODS: Between February 2005 and December 2009, a total of 11,064,532 donors were screened for anti-HCV and 11,412,690 donors were screened for HCV RNA. HCV genotyping was conducted for 748 blood donors with HCV RNA by using the line probe assay (VERSANT HCV Genotype 2.0 Assay, Bayer Healthcare, USA) after amplification of the 5'-untranslated and core regions of the genome. RESULTS: The anti-HCV prevalence was 0.16% (17,250/11,064,532). HCV RNA was detected in 959 out of the 11,412,690 donors (8.4/100,000). HCV RNA was more prevalent among women, donors who resided at harbor sites, and first-time donors. In addition, the prevalence of HCV RNA increased with age. The genotypes of 740 out of the 748 tested donors (98.9%) were identified. HCV genotype 1b (47.7%) and 2a/2c (35.0%) were dominant. Genotypes 2 (7.6%), 2b (2.3%), 3a (1.6%), 1a (1.3%), 1 (0.9%), 2v (0.5%), 1v (0.1%), and 3 (0.1%) were also identified. Genotype 4a/4c/4d (0.1%) was detected for the first time in one Korean blood donor. CONCLUSIONS: The distribution of HCV genotypes in Korea has not changed remarkably, with the exception of genotype 4a/4c/4d. A periodic study to monitor the prevalence of HCV infections and the distribution of HCV genotypes is required to identify emerging genotypes in Korea.

[Evaluation of the virus-elimination efficacy of nanofiltration (Viresolve NFP) for the parvovirus B19 and hepatitis A virus].

BACKGROUND: The safety of plasma derivatives has been reinforced since 1980s by variable pathogen inactivation or elimination techniques. Nucleic acid amplification test (NAT) for the source plasma has also been implemented worldwide. Recently nanofiltration has been used in some country for ensuring safety of plasma derivatives to eliminate non-enveloped viruses such as parvovirus B19 (B19V) and hepatitis A virus (HAV). We evaluated the efficacy of nanofiltration for the elimination of B19V and HAV. METHODS: To verify the efficacy of nanofiltration, we adopted a 20 nm Viresolve NFP (Millipore, USA) in the scaling down (1:1,370) model of the antithrombin III production. As virus stock solutions, we used B19V reactive plasma and porcine parvovirus (PPV) and HAV obtained from cell culture. And 50% tissue culture infectious dose was consumed as infectious dose. The methods used to evaluate the virus-elimination efficacy were reverse-transcriptase polymerase chain reaction for B19V and the cytopathic effect calculation after filtration for PPV and HAV. RESULTS: B19V was not detected by RT-PCR in the filtered antithrombin III solutions with initial viral load of 6.42 x 10(5) IU/mL and 1.42 x 10(5) IU/mL before filtration. The virus-elimination efficacy of nanofiltration for PPV and HAV were > or = (3.32) and > or = (3.31), respectively. CONCLUSIONS: Nanofiltration would be an effective method for the elimination of B19V and HAV. It may be used as a substitute for NAT screening of these viruses in source plasma to ensure safety of plasma derivatives in Korea.

Investigation of the prevalence of human parvovirus B19 DNA in Korean plasmapheresis donors.

BACKGROUND: To ensure the safety of plasma derivatives, some countries have been screening for the human parvovirus B19 (B19V) antigen or DNA in blood donors. We investigated the prevalence of B19V DNA and anti-B19V antibodies in Korean plasmapheresis donors to evaluate the necessity of B19V DNA screening test. METHODS: Plasma samples were collected between March and July 2008 from 10,032 plasmapheresis donors. The B19V DNA test was performed using the LightCycler 2.0 (Roche, Germany) with quantification kits. Anti-B19V IgM and IgG were tested in 928 randomly selected samples from the 10,032 donors using recomWell Parvovirus B19 ELISA IgM, IgG assay (Mikrogen, Germany). RecomLine Parvovirus B19 LIA IgG, IgM assay (Mikrogen, Germany) was used to analyze the epitopes of antibodies in donors showing positive results for B19V DNA and anti-B19V antibodies. DNA sequencing was performed to identify the genotypes. RESULTS: The prevalence of B19V DNA was 0.1% (10/10,032). Virus titers in B19V DNA positive donors were less than 10(5) IU/mL (range: 2.7 x 10(1)-3.2 x 10(4) IU/mL) except for 1 donor (1.33 x 10(8) IU/mL). All the isolated B19V DNAs from 6 donors were identified as genotype I. Nine out of 10 B19V DNA positive donors also possessed anti-B19V IgG only or IgG and IgM. The prevalence of anti-B19V IgG was 60.1% (558/928). CONCLUSIONS: The prevalence of B19V DNA in Korean blood donors was not high and most donors also possessed neutralizing anti-B19V antibodies. Thus, the implementation of a B19V screening test for Korean blood donors does not appear to be imperative.