Suggestions for Specialization and Enhancing Capacity in National Blood Services / 대한수혈학회지

Blood is an essential medical resource for treating diseases and trauma of people, but a limited biological resource for which no artificial production is possible. Therefore, systematic and rational management of its supply and use must be carried out under the national responsibility. On the other hand, the low birthrate and aging population have raised the problem of blood shortages in Korea. To help solve this problem, this study examined proposals for the development of a blood management system in Korea. In addition, the works of blood management bodies were analyzed based on the operation subjects and types of blood projects in the United States, the United Kingdom, France, Germany, the Netherlands, Canada, Australia, Singapore, and Japan. Based on these data, this paper proposes a new organization that can best enhance the specialization of national blood services and strengthen its capacity under the current blood supply system in Korea.

Development of Educational Material for Blood Donor Interview through the Cognitive Evaluation of Donor History Questionnaires / 대한수혈학회지

BACKGROUND: Screening for healthy blood donors through donor interviews is essential to the safety of donors and blood resources. Our goal was to suggest educational material for donor interviewers and donors, as well as supplemental material for interview sites, which will help provide an effective interview process. METHODS: We conducted surveys regarding experiences in donor interviews from donor interviewers and cognitive interviews about difficulties during interview from blood donors between September and October of 2015. We additionally conducted a post-survey about provided educational and supplemental materials between December 2015 and January 2016. RESULTS: The possibility of an incorrect answer in the donor history questionnaire (DHQ) was high for questions about sexual contact, imprisonment, or medication, and the reasons were incorrect memories, ignorance about donor interview, or protection of privacy. Cognitive interviews of donors revealed questions and terminology that are difficult to understand. Donor interviewers could obtain improved understanding of the DHQ through educational materials, which were found to be useful for new interviewers or donors. Use of a supplemental flip book for the interview process was found to be useful, especially for blood centers with small blood donations. CONCLUSION: This study investigated difficulties in the donor interview from the perspective of donor interviewers and donors and suggested educational and supplemental materials to address these difficulties. These materials will induce correct and honest answers from blood donors through education and guidance about the donor interview process and help secure the safety of blood products.

Annual Report on the External Quality Assessment Scheme of Viral Markers and Serological Tests for Syphilis in Korea (2014)

As Immunoserology Subcommittee of the Korean Association of External Quality Assessment Service, we organized two trials on the external quality assessment of viral markers and serological tests for syphilis (STS) in 2014. For this purpose, we delivered three kinds of pooled sera specimens for external proficiency testing to 1,060 and 1,064 institutions for the first and second trials, respectively. Pooled sera were checked for their homogeneity and stability by using more than three other methods between the day of their manufacture and 3 days after despatching. The numbers of participating laboratories were 1,053 (99.3%) and 1,046 (99.3%) in the first and second trials, respectively. The most commonly tested items were hepatitis B surface antigen, followed by antibody to hepatitis B surface antigen, anti-human immunodeficiency virus, anti-hepatitis C virus, STS, and anti-hepatitis B core. The most frequently used methods for detecting viral markers were the chemiluminescence immunoassay (CLIA) and the electrochemiluminescence immunoassay, which generated few false positive results. In contrast, false negative results were frequently found through the immunochromatography assay, the use of which for detecting viral markers has been steadily increasing in recent years. Furthermore, the use of turbidoimmunoassay and CLIA, which are new tests recently introduced for the measurement of non-treponemal and treponemal antibodies, is also increasing.

Establishment and Multicenter Evaluation of a National Reference Panel for Syphilis Antibodies in Korea

BACKGROUND: Establishment of a national reference panel for syphilis antibodies is necessary to evaluate the performance of in-vitro diagnostic tests for syphilis and to verify test quality. This study aimed to establish a national reference panel for syphilis antibodies, to assess the suitability of a panel for non-treponemal and treponemal testing, and to assess the reactivity of the various tests currently in use. METHODS: Treponemal pallidum particle agglutination (TPPA)-positive and -negative fresh frozen plasma samples were obtained. After the fresh frozen plasma was converted to serum by defibrination, the samples were pooled. Two candidate reference standards containing no syphilis antibodies and 10 candidate reference standards containing syphilis antibodies were prepared on the basis of reactivity in the TPPA assay. Candidate reference standards were tested by three laboratories using five non-treponemal tests and four treponemal tests. RESULTS: All three laboratories reported positive non-treponemal test results for the mixed-titer performance panel (MP)/6-MP/12. MP/1, MP/2, and MP/3 were negative for non-treponemal tests. MP/4 and MP/5 were reported either as positive or negative according to the laboratories. All laboratories reported positive TPPA results for MP/3-MP/12 and negative results for MP/1 and MP/2. No significant difference was detected among the treponemal testing results in three laboratories. CONCLUSIONS: We established 12 candidate national reference standards containing various concentrations of syphilis antibodies. A collaborative study using nine tests demonstrated that 12 candidate national reference standards presented consistent results, except a few assays with low sensitivity, and thus could be used as a national reference panel for syphilis antibody testing.

Comparison of the Accuracy of Noninvasive Hemoglobin Sensor (NBM-200) and Portable Hemoglobinometer (HemoCue) with an Automated Hematology Analyzer (LH500) in Blood Donor Screening

BACKGROUND: The Hb levels of prospective blood donors are usually determined using a finger prick test. A new noninvasive Hb device has the advantage of not causing any sampling pain. The purpose of this study was to evaluate the accuracy of the noninvasive Hb sensor and to compare its measurements with those of a currently used portable hemoglobinometer. METHODS: Hb was measured using a noninvasive Hb sensor (NBM-200; OrSense, Israel), a portable hemoglobinometer (HemoCue; HemoCue AB, Sweden), and an automated hematology analyzer (LH500; Beckman Coulter, USA). The correlations between Hb measurements taken by the NBM-200 and HemoCue with those by an automated hematology analyzer were assessed using intraclass correlation coefficients (ICCs). Hb measurements were compared among 3 different Hb level groups. RESULTS: The mean Hb values of 506 blood donors were 14.1 g/dL by the NBM-200, 14.0 g/dL by the LH500, and 14.3 g/dL by the HemoCue. The correlation between the LH500 and the NBM-200 was substantial (ICC=0.69), while that between the LH500 and the HemoCue agreed almost perfectly (ICC=0.86). CONCLUSIONS: The possibility to judge to be eligible for donors who are ineligible to donate was substantial when using NBM-200. Even though the NBM-200 has the apparent advantage of noninvasiveness, its use in pre-screening should be given meticulous attention. Since pre-donation testing is crucial to protecting donors' health, complete evaluation of the instrument should be performed prior to use.

Performance Evaluation of the OraQuick Hepatitis C Virus Rapid Antibody Test

BACKGROUND: A reliable rapid assay for hepatitis C virus (HCV) may be helpful in various clinical settings. We evaluated the performance of the OraQuick HCV Rapid Antibody Test (OraSure Technologies Inc., Bethlehem, PA, USA). METHODS: Clinical sensitivity and specificity were evaluated with oral fluids and sera from 137 patients diagnosed with hepatitis C and 300 healthy blood donors in a multi-center collaborative study. The stored sera of 200 proven HCV-infected patients and 200 healthy subjects were also evaluated. Analytical sensitivity was estimated with 4 commercial seroconversion panels and 7 Korean reference panels. The performance of 4 laboratory-based tests (3 chemiluminescence assays and 1 enzyme immunoassay) and 4 rapid test kits was compared. We also assessed the interference due to bilirubin, hemoglobin, lipid, rheumatoid factor, multipara, and several viral infections. RESULTS: The clinical sensitivity and specificity of the OraQuick HCV test using oral fluid were 97.8% (95% confidence interval [CI], 93.2-99.4%) and 100% (95% CI, 98.4-100%), respectively. The clinical sensitivity using serum samples was 100%. Using the 4 seroconversion panels, the OraQuick HCV test showed results comparable to those of the laboratory-based assays; its analytical sensitivity was higher than that of the other rapid test kits. There was no cross-reactivity with common interfering factors. CONCLUSIONS: The clinical performance of the OraQuick HCV Test is comparable to that of laboratory-based tests with both serum and oral fluid. This supports the supplementary use of rapid HCV testing using oral fluid in various medical and non-medical settings.

Performance Evaluation of the OraQuick Hepatitis C Virus Rapid Antibody Test

BACKGROUND: A reliable rapid assay for hepatitis C virus (HCV) may be helpful in various clinical settings. We evaluated the performance of the OraQuick HCV Rapid Antibody Test (OraSure Technologies Inc., Bethlehem, PA, USA). METHODS: Clinical sensitivity and specificity were evaluated with oral fluids and sera from 137 patients diagnosed with hepatitis C and 300 healthy blood donors in a multi-center collaborative study. The stored sera of 200 proven HCV-infected patients and 200 healthy subjects were also evaluated. Analytical sensitivity was estimated with 4 commercial seroconversion panels and 7 Korean reference panels. The performance of 4 laboratory-based tests (3 chemiluminescence assays and 1 enzyme immunoassay) and 4 rapid test kits was compared. We also assessed the interference due to bilirubin, hemoglobin, lipid, rheumatoid factor, multipara, and several viral infections. RESULTS: The clinical sensitivity and specificity of the OraQuick HCV test using oral fluid were 97.8% (95% confidence interval [CI], 93.2-99.4%) and 100% (95% CI, 98.4-100%), respectively. The clinical sensitivity using serum samples was 100%. Using the 4 seroconversion panels, the OraQuick HCV test showed results comparable to those of the laboratory-based assays; its analytical sensitivity was higher than that of the other rapid test kits. There was no cross-reactivity with common interfering factors. CONCLUSIONS: The clinical performance of the OraQuick HCV Test is comparable to that of laboratory-based tests with both serum and oral fluid. This supports the supplementary use of rapid HCV testing using oral fluid in various medical and non-medical settings.

Survey Analysis of the Current Blood Donor Interview / 대한수혈학회지

BACKGROUND: An objective and standardized interview process is important when screening for healthy blood donors. Our aims were to gather opinions of the interviewing nurses at blood centers on the current donor interview and to suggest improvements to the interview. METHODS: We conducted an anonymous survey consisting of five questions regarding the donor health questionnaire, which can be found on the reverse side of the donation record card. The survey targeted the interviewing nurses with more than 1 year of experience at collection sites of the Korean Red Cross and the Hanmaum blood centers. The survey was sent out and gathered via mail, fax or email between September and October of 2010. RESULTS: The average self-deferral rate of donors prior to interview was 7.4%, and 66.7% of the interviewing nurses considered 'taking medicine' as the most common reason for donor self-deferral. The past and current history of disorders was the hardest question for nurses to determine the eligibility of the donors. Having a history of blood transfusion, surgery, tattoo or a piercing procedure, etc. within a year was the most unacceptable reason for deferred donors. The nurses strongly recommended revision of redundant questions as well as re-examining the unsolvable dilemma of questions concerning malaria. CONCLUSION: According to the survey, this study outlines the perspectives of interviewing nurses at blood centers regarding the rate and reasons for self-deferral of blood donors, the difficulties and the suggestions for improving the current donor interview. The results will be helpful in the future when proposing modifications to the donor interview.

The Hemoglobin Distribution of Korean Blood Donors / 대한수혈학회지

BACKGROUND: The current donor selection criteria need to be revised to ensure a reliable blood supply and for donor protection. This study was conducted to analyze the distribution of hemoglobin (Hb) levels of blood donors and to estimate the change of eligible donors when using the revised Hb criterion. METHODS: The Hb levels of all the blood donors who visited the Korean Red Cross Blood Center (KRCBC) between November 9th, 2010 and November 15th, 2010 were measured with a portable hemoglobinometer (HemoCue). The Hb levels of all the eligible donors and some of the deferred donors who visited the Hanmaeum Blood Center (HBC) from April 26th, 2010 to April 30th, 2010 and from November 9th, 2010 to November 15th, 2010 were measured with a portable hemoglobinometer (Hemo_Control). RESULTS: A total of 7,521 donors (6,500 eligible donors and 1,021 deferred donors) were enrolled. The donation eligibility rate at the KRCBC, which is where all the donors were examined, was 84.2% (3,409/4,049) and the deferral rate was 15.8% (640/4,049). The percent of blood donors whose Hb level was less than 12.5 g/dL was 2.1% of the men (44/2,145) and 34.9% of the women (664/1,904), respectively. The percent of female deferred donors with a Hb level of 12.0~12.4 g/dL was 19.3% (109/564) and the percent of male eligible donors with a Hb level of 12.5~12.9 g/dL was 2.6% (54/2,069). At the HBC, and with some deferred donors being excluded, the deferral rate of males and females was 2.0% (36/1,799) and 20.6% (345/1,673), respectively. CONCLUSION: About 20% of the female deferred donors could be expected to participate when a less strict Hb criterion (> or =12.0 g/dL) is applied. This study is thought to be helpful in order to determine the number of donors according to the Hb criteria and to create improved criteria.

True Hepatitis B Virus Surface Antigen Prevalence among Korean Blood Donors / 대한수혈학회지

BACKGROUND: The sensitivity of the blood screening test is crucial to ensure blood safety. Generally the test methods with greater sensitivity tend to have lower specificity. Therefore, secondary confirmatory tests are required to solve this problem. Since the confirmatory test for hepatitis B virus surface antigen (HBsAg) has not been routinely applied yet in Korea for blood donors, the true positive rate of HBsAg is unknown. This study was intended to determine the true seroprevalence of the hepatitis B virus (HBV) among Korean blood donors. METHODS: A total of 906 blood donor samples found to be positive for HBsAg with Prism qualitative assay from November 2010 to April 2011 at Korean Red Cross blood centers were tested with Architect HBsAg qualitative assay and confirmatory assay. Blood samples with negative results using Architect HBsAg qualitative assay were tested with Prism HBsAg confirmatory test. RESULTS: Of the 906 samples positive by Prism HBsAg qualitative assay, 793 were confirmed as positives. The positive predictive value of Prism HBsAg qualitative assay was 87.5%, and the true seroprevalence of HBV among Korean blood donors was 8 out of 100,000. The sample-to-cut-off ratio (S/CO) value of one true positive sample was lower than 1. CONCLUSION: The positive predictive value of HBsAg by Prism was higher than expected. Baseline data for estimation of residual risk of HBV as well as the cost-effectiveness analysis for lookback policy were drawn. Finally, the current cut-off level for repeat assay looked reasonable and it should be maintained at least until the nucleic acid amplification test is implemented as a routine screening method.

Plasma fractionation in Korea: working towards self-sufficiency / 대한혈액학회지

No abstract available.

Determining the Cause of Discrepant Results in HCV NAT Comparative Tests / 대한수혈학회지

BACKGROUND: The Korean Red Cross blood laboratory centers have been performing comparative tests for NAT reactive specimens since February 2005. However, five discrepant specimens were found in HCV-diluted specimens between 2007 and 2008 and the reasons for this has been investigated. METHODS: For the five discrepant specimens, the HCV RNA concentration was measured in 5 tubes for each speciment. Subsequently, in order to compare the sensitivity of the low titer specimens measured by RT-PCR and TMA, comparative tests of diluted samples were examined six times per sample. Finally, the genotype was tested in order to determine the characteristics of the discrepant samples. RESULTS: Result of the quantitative tests for HCV RNA demonstrated that aliquots of the plasma bag were homogenous in term of viral load quantitation. As a result of the comparative test, all samples were found to contain over 1.0x10(1) IU/mL as detected by the two analytical systems. In contrast, those less than 1.0x10(1) IU/mL were not entirely detected by the two systems. CONCLUSION: It was impossible to completely detect using the two NAT system and the detection rates for both systems were equivalent for the samples examined. In particular, with respect to HCV, it may be undetectable on the NAT test because viral load decreases rapidly before and after sero-conversion. This result indicates that anti-HCV and NAT should be performed together as an HCV screening test prior to blood donation.

Quality Assessment of Red Blood Cells, Pooled Platelets and Frozen Plasma Processed by the Buffy Coat Method / 대한수혈학회지

BACKGROUND: Buffy coat method is one of the blood components processing methods widely used in many countries including Europe and Canada. For the first time in Korea, we evaluated the qualities of blood components manufactured by buffy coat method. METHODS: We collected 400 mL whole bloods using the quadruple top and bottom blood bag from thirty-five donors. Whole bloods were processed into leukoreduced RBC, leukoreduced pooled platelet, and 24 hr frozen plasma by the buffy coat method with blood bags and instruments of Fenwal and Fresenius. The qualities of each blood component were analyzed at each scheduled day, and compared with the standard guidelines of quality control in Korean Red Cross. RESULTS: The volume and hemoglobin of RBCs were lower than the standard guidelines. Comparing with the standard of apheresis platelets, leukoreduced pooled platelets showed higher total platelet yield with the median 3.70x10(11)/unit. Frozen plasma showed increased volume recovery than the standard guideline, but the activity of factor VIII at Day 35 was decreased to 0.66+/-0.14 IU/mL. CONCLUSION: We have found that the yields of pooled platelet and the frozen plasma processed by buffy coat method were higher than the standard guidelines. To introduce the buffy coat method to routine blood component separation process in Korea, further evaluations about the cost-effectiveness of buffy coat method are required.

Results of Serologic Screening Tests from Blood Donors at One University Hospital-based Blood Bank during 2006~2008 / 대한수혈학회지

BACKGROUND: Any data on the prevalence of the infectious diseases of blood donors at a university hospital-based blood bank is not available. We aimed to analyze the seroincidence of screening tests from blood donors at a university hospital-based blood bank in Korea. METHODS: We retrospectively analyzed all the samples of blood donors during the previous three years from January 2006 to December 2008. HBsAg and HIV Ab/Ag Combo test were performed by chemiluminescent immunoassays, and anti-HCV was performed by enzyme-linked immunosorbent assay and electrochemiluminescent immunoassay. Serologic testing for syphilis was done by VDRL (venereal disease research laboratory test) and RPR (rapid plasma regain test). RESULTS: The number of total blood donors that underwent screening tests were 1,279 in 2006, 1,355 in 2007 and 941 in 2008, respectively. HBsAg was positive in 8 cases among the 1,279 donors (0.63%) in 2006, in 10 cases of the 1,355 donors (0.74%) in 2007 and in 5 cases of the 941 donors (0.53%) in 2008. Anti-HCV was positive in 3 cases (0.24%) in 2006, 2 cases (0.15%) in 2007 and 2 cases (0.21%) in 2008. One of them was dual positive for HBsAg and anti-HCV. There's no positive case of anti-HIV (0%) during the 3 years. Serologic testing for syphilis (VDRL) was positive in 7 cases (0.55%) in 2006, in 5 cases (0.37%) in 2007 and in 5 cases (0.53%) in 2008. CONCLUSION: The seroincidence was different between a university hospital-based blood bank and the Korean Red Cross Blood Service center. This difference might be due to the composition of donors, i.e., autologous blood donors and directed donors in the university-based blood bank.

International Comparison of Blood Product Prices / 대한수혈학회지

BACKGROUND: Due to the slowing of population growth, population ageing, and more aggressive medical treatment, Korea will be faced with the challenge of blood shortage. One solution to the blood shortage problem is to take advantage of the multicomponent collection technique. However, clinical application is limited due to the low prices of blood products. In this study, we compared the prices of blood products in 6 major countries. METHODS: Prices of leukoreduced red blood cells (RBC), platelet concentrate (PC), fresh frozen plasma (FFP), cryoprecipitate (CRYO), and apheresis platelets (AP) were compiled from US, United Kingdom, Japan, Australia, Spain, and Korea. Adjusted prices using per capita gross domestic product (GDP) and purchasing power parity (PPP) were estimated and analyzed. RESULTS: The RBC price in Korea was only 30% of the mean RBC price of the other 5 countries. Considering per capita GDP and PPP, the RBC prices in Korea were estimated up to 41% and 46%, respectively. The PPP adjusted price of PC, FFP, and AP of Korea was 70%, 72%, and 70% of mean price of the other 5 countries. Price ratios of PC, FFP, and CRYO to RBC were 0.59, 0.63, and 0.57, which were higher than the means of the other 5 countries (0.38, 0.47, and 0.32). CONCLUSION: Considering per capita GDP and PPP, blood product prices in Korea were cheaper than the mean prices of the other 5 countries. For adoption of multicomponent collection, the prices of blood products should be raised, especially the price of RBCs.

Development of a Web-based Donor Eligibility Expert System / 대한수혈학회지

BACKGROUND: The determination of blood donor eligibility has become critical and challenging to blood operators as so many conditions and restrictions should be considered to correctly decide the donor eligibility. Since the launching of the BIMS (Blood Information Management System) in May 2003, the demand of developing a more intelligent system to assist the determination of donor eligibility has been growing. The Korean Red Cross Blood Service intended to develop an expert system for donor eligibility determination with high efficiency and ease of use. METHODS: The content of the system was determined through the activity of a team consisting of medical doctors, nurses, safety managers, and the system developers. Algorithms were developed according to the donor history taking process. The efficiency of the system was tested by the comparison of the time needed for inquiries and the number of inappropriate blood collections before and after the implementation of the new system. RESULTS: The new system's user interface integrated many complicated work processes with a user-friendly flexibility. The types of decision included the restricted donations. The donor interviewers were highly satisfied with the system because almost all cases were correctly determined in a relatively short time. Using this system, the number of inappropriate blood collections was significantly lowered. CONCLUSION: We developed an expert system that can aide the donor eligibility determination process and prevent the violation of the related regulations. This system will contribute to enhancement of the blood safety as well as donor protection for our blood services.

Development of a Web-based Donor Eligibility Expert System / 대한수혈학회지

BACKGROUND: The determination of blood donor eligibility has become critical and challenging to blood operators as so many conditions and restrictions should be considered to correctly decide the donor eligibility. Since the launching of the BIMS (Blood Information Management System) in May 2003, the demand of developing a more intelligent system to assist the determination of donor eligibility has been growing. The Korean Red Cross Blood Service intended to develop an expert system for donor eligibility determination with high efficiency and ease of use. METHODS: The content of the system was determined through the activity of a team consisting of medical doctors, nurses, safety managers, and the system developers. Algorithms were developed according to the donor history taking process. The efficiency of the system was tested by the comparison of the time needed for inquiries and the number of inappropriate blood collections before and after the implementation of the new system. RESULTS: The new system's user interface integrated many complicated work processes with a user-friendly flexibility. The types of decision included the restricted donations. The donor interviewers were highly satisfied with the system because almost all cases were correctly determined in a relatively short time. Using this system, the number of inappropriate blood collections was significantly lowered. CONCLUSION: We developed an expert system that can aide the donor eligibility determination process and prevent the violation of the related regulations. This system will contribute to enhancement of the blood safety as well as donor protection for our blood services.

Characteristics of Human Immunodeficiency Virus Type 1 Reactive Blood Donors Following Nucleic Acid Amplification Test Screening / 대한수혈학회지

BACKGROUND: The Korean Red Cross has established three nucleic acid amplification test (NAT) centers, and the organization has begun NAT screening for human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) for domestic blood donors commencing from February 2005. As a result, between February 2005 and July 2006, it was found that 80 of a total of 3,481,972 donors that were screened were positive for HIV-1 as determined by the NAT. This report will describe the characteristics of the HIV-1 positive reactive donors. METHODS: We attempted to determine the number of HIV-1 positive reactive donors for each NAT center, and attempted to characterize the donors by gender, age, RNA viral load, and the distribution of HIV-1 subtype. RESULTS: Among the 80 HIV-1 positive reactive donors determined by the NAT, 57.5% of the donors were in their twenties and all but one of the donors was male. Of all of the donors, 82.5% were repeated donors and four donors showed antibody negative window periods. The average quantity of HIV-1 RNA for 78 donors was 1.12x105 copies/mL and for the four donors that showed the antibody negative window periods was 2.68x105 copies/mL. The HIV-1 subtypes of 76 cases were all B of group M. CONCLUSION: NAT screening contributes to the safety of the domestic blood supply. Therefore, it is necessary to continue to study the characteristics of the blood that was found to show HIV positivity by the NAT.

Characteristics and Follow-up Results of the Window Period Blood Donors for Hepatitis C Virus / 대한수혈학회지

BACKGROUND: To improve the safety of the blood supply in Korea, nucleic acid amplification testing (NAT) for HCV and HIV-1 as a blood screening test has been used by the Korean Red Cross since February 1st, 2005. Until October 31st 2006, a total of 4,037,618 donor samples had been tested and 436 cases showed reactivity for HCV RNA. Only 10 of these cases showed serologically negative antibody results. METHODS: We investigated the characteristics and the follow-up results of the ten donors who showed HCV RNA reactivity and serologically negative results. RESULTS: All the ten donors were identified to be "window period" blood donors with confirmation of their seroconversion by follow-up testing. The average RNA titer of the donors was 9.21x106 IU/mL. Five donors showed high levels of ALT. One donor showed the reversed pattern on the test results for antibody and RNA. CONCLUSION: By detecting five cases of HCV "window period" infection, NAT has increased the safety of the Korean blood supply. But it is considered that NAT can not be a substitute serological test and an adequate follow-up strategy is required for verification of the accurate seroconversion time.

The Analysis of the Effect of Mixing of Anticoagulant on Nucleic Acid Amplification Tests for Donated Blood / 임상검사와정도관리

BACKGROUND: In the process of implementing the nucleic acid amplification tests (NAT) for the blood screening, it was needed to change plain tube to EDTA tube for the sampling. Because the sample is taken from the CPDA-1 anticoagulated whole blood, the EDTA of tube could be mixed with the CPDA-1. So, we studied the effect of the mixing of two anticoagulants on the NAT. METHODS: Using HIV-1 and HCV RNA standards, we made the qualitative and quantitative test panels for the EDTA anticoagulant and the EDTA/CPDA-1 anticoagulant containing blood. The reverse transcription-polymerase chain reaction of Roche and transcription-mediated amplification of Chiron were used for the RNA qualitative and quantitative test. RESULTS: On the qualitative HIV-1 and HCV RNA tests for the EDTA, CPDA-1 alone and the CPDA-1/EDTA mixture, false negative and false positive reactions were not observed. On quantitative test, viral loads were not different statistically. CONCLUSIONS: Since there were no statistically significant differences between CPDA-1 alone and EDTA/CPDA-1 mixture in both qualitative and quantitative tests for HIV-1 and HCV RNA, it was concluded that mixing of anticoagulants, EDTA and CPDA-1, would not cause an significant effect on the NAT for the donated blood.