HBsAg non-reactive but HBV DNA reactive blood donors in Wuhu area: infection status and tracing results / 中国输血杂志

【Objective】 To detect and analyze the infection status of HBsAg non-reactive /HBV DNA reactive blood donors by individual donor-NAT (ID-NAT) and chemiluminescence technology, and to explore the feasibility and potential risks of reentry. 【Methods】 The blood screening results of blood donors in Wuhu from January 2018 to October 2021 were queried by blood station information management software. The blood donation information of all HBsAg non-reactive /HBV DNA reactive blood donors was collected and then recalled by telephone. After informed consent, samples were taken for HBV DNA nucleic acid single test, enzyme-linked immunoassay for HBsAg, chemiluminescence assay for HBV seromarkers(including HBsAg, anti-HBs, HBeAg, anti-HBe and anti-HBc), and alanine aminotransferase (ALT) test. All the results were statistically analyzed. 【Results】 From January 2018 to October 2021, there were 142 051 donations, and the positive rate of sole HBV DNA was 0.06% (91/142 051), and 33 people (37 person-times) were successfully followed up. The yield rates of HBsAg, anti-HBs and anti-HBc were 6.06% (2/33), 39.39% (13/33) and 96.97% (32/33), respectively; None HBeAg was yielded. After two times of ID-NAT, 8 patients remained non-reactive to both systems, with a negative conversion rate of 24.24% (8/33). Meanwhile, 25 patients were at least once reactive to ID-NAT, and 23 of them were occult HBV infection with serologically reactivity. There were 2(6.25%) patients with HBsAg positive conversion and HBV DNA persistent reactivity, which were window period infection. One person was confirmed as false reactivity (no HBV infection) as he remained unreactive to both repeated ID-NAT and serological tests. 【Conclusion】 Chemiluminescence assay is more sensitive than ELISA in detecting HBV serum markers, which is beneficial to early detection of HBV samples in window period. The yielding rate of anti-HBc among HBsAg non-reactive/HBV DNA reactive blood donors detected by blood screening in this region is very high, and most of them are occulting infection, so the ID-NAT should be no less than 2 times in the reentry strategy.

Análisis de la problemática resultante de los tipos de donación de sangre, producida en el Banco de Sangre de la Seguridad Social en La Paz durante la gestión 2020 / Analysis of the problems resulting from the types of blood donation, produced at the social security Blood Bank in La Paz during the 2020 administration

INTRODUCCIÓN: actualmente la sangre continúa siendo un elemento vital para la vida, su fabricación aún no ha sido optimizada, por lo tanto, solo puede obtenerse a través de donaciones humanas. Por ello, para los Bancos de Sangre, contar con personas de confianza que aporten sangre constituye uno de los principales problemas éticos. Actualmente existen tres tipos de donación de sangre: la donación voluntaria y altruista, la donación de reposición o familiar y la donación remunerada, siendo esta última inaceptable en términos económicos y sanitarios, además de estar prohibida en el marco legal vigente en nuestro país. OBJETIVOS: analizar la problemática de la donación de sangre, haciendo énfasis en los tipos de donaciones que existen en nuestro país, considerando cuál es el tipo de donación más seguro para el receptor y cuáles son los menores de las pruebas de tamizaje inmunoserológico. MATERIALES Y MÉTODOS: se realizó un estudio transversal analítico, retrospectivo, en el que se revisaron las historias clínicas y los formularios electrónicos de trabajo utilizados en la recolección de datos de las donaciones de sangre obtenidas en el Banco de Sangre. de la seguridad social. Para el análisis estadístico se realizó la media y la varianza. RESULTADOS: de un total de 7787 personas que se presentaron a donar sangre, solo 5166 realizaron una donación efectiva. El resto fueron diferidos temporalmente por causas subsanables, 147 fueron diferidos definitivamente por enfermedades e infecciones que pudieran suponer un riesgo para el receptor y en 19 de ellos la extracción de sangre fue difícil por dificultad de acceso venoso. Según el tipo de donaciones, el 52,8 % fueron donaciones solidarias de reposición, el 43,3 % donación exijida y el 3,71 % donación voluntaria. Finalmente, el 68 % del total de las donaciones de sangre provino de hombres. CONCLUIONES: los datos obtenidos demuestran porcentajes muy bajos de donantes voluntarios y valores altos de donantes obligados a donar, muy en relación a países con programas deficientes de donación voluntaria y altruista de sangre.

INTRODUCTION: currently blood is a vital element for life, its manufacture has not yet been optimized, therefore, it can only be obtained through human donations. For this reason, for Blood Banks, having reliable people who provide blood constitutes one of the main ethical problems. There are currently three types of blood donation: voluntary and altruistic donation, replacement or family donation, and paid donation, the latter being unacceptable in economic and health terms, as well as being prohibited under the current legal framework in our country. OBJECTIVES: analyze the problem of blood donation, emphasizing the types of donations that exist in our country, considering what is the safest type of donation for the recipient and what are the minors of immunoserological screening tests. MATERIALS AND METHODS: this was a retrospective, analytical cross-sectional study, in which, we reviewed clinical histories and electronic work forms used in the collection of data on blood donations obtained in the Blood Bank. of social security. For statistical analysis we performed the mean and variance. RESULTS: in a total of 7787 people who presented themselves to donate blood, only 5166 made an effective donation. The rest were temporarily deferred for rectifiable reasons, 147 were permanently deferred due to diseases and infections that could cause a risk to the recipient and in 19 of them it was difficult to draw blood due to difficult venous access. According to the type of donations, 52.8 % were solidarity replacement donations, 43.3 % required donation, and 3.71 % voluntary donation. Finally, 68 % of the total blood donations came from men. CONCLUSIONS: the data obtained show very low percentages of voluntary donors and high values of required donors, these results are in accordance with countries with deficient voluntary and altruistic blood donation programs.

Investigation on current Hepatitis E virus infection among voluntary blood donors / 中国输血杂志

【Objective】 To investigate the situation of hepatitis E virus(HEV) infection among voluntary blood donors in Wuhan area and provide evidences for enhancing blood screening strategies. 【Methods】 HEV nucleic acid detection(NAT) was performed on blood samples from eligible blood donors in Wuhan from November to December 2020. The testing results were analyzed, and the blood donors with repeated reactive results were followed up to clarify the status of infection. 【Results】 Routine screening was performed on 17 409 blood samples from November to December 2020. A total of 17 322 blood samples of eligible blood donors were tested for HEV NAT, and one case of HEV RNA reactivity was detected. The results from the follow-ups showed that the blood donor should be in the window period of HEV seroconversion. The current HEV infection rate of voluntary blood donors in Wuhan arewas 0.058‰(1/17 322), which was lower than other domestic areas. 【Conclusion】 The current HEV infection rate of voluntary blood donors was at a relatively low prevalence level in Wuhan area. Selective blood screening strategies can be taken to further reduce potential risk of blood transfusion infection with hepatitis E virus.

Assessment of residual risk of hepatitis C virus transmission by blood transfusion in Taiyuan / 中国输血杂志

【Objective】 To analyze the epidemic of hepatitis C virus (HCV) in voluntary blood donors , and to assess the residual risk of HCV transmission by blood transfusion in Taiyuan. 【Methods】 The HCV screening results of voluntary blood donors in Taiyuan from 2016 to 2021 were collected by blood center information system, and the epidemiologic feature of first-time and repeated donors were analyzed. The incidence-window period model was used to assess the residual risk of HCV transmission by transfusion in first-time/repeated donors as well as that in repeated donors under different blood screening modes. 【Results】 Of the 662 705 samples in Taiyuan from 2016 to 2021, the HCV positive rate of the first-time donors was 1.83‰(595/325 009) and the residual risk of HCV transmission was 14.91/100 000. The HCV positive rate of the repeated donors was 0.04‰ (13/337 696) and the residual risk was 0.31/1 000 000. The total residual risk of HCV transmission was 7.47/1 000 000. A total of 337 696 blood samples of repeated blood donors were tested, the repeated blood donors’ residual risk of transfusion-transmitted HCV was 0.31/100 000 after dual ELISA tests , and 0.06/100 000 after dual ELISA and once NAT, which reduce by 80.65% since NAT were adopted. 【Conclusion】 The residual risk of HCV transmission from repeated donors was less than that from first-time donors. The blood screening mode of HCV by dual ELISA and once NAT can effectively reduce the residual risk of transfusion-transmitted HCV and improve blood safety. The rate of repeat blood donation needs to be increased by continuously optimizing the recruitment strategy of blood donors.

ECLIA and confirmation results of HIV reactive samples in blood screening / 中国输血杂志

【Objective】 To perform electrochemiluminescence immunoassay (ECLIA) and Western blotting (WB) confirmation tests for HIV reactive samples in blood screening, and analyze the correlation between ELISA (enzyme-linked immunosorbent assay), ECLIA results and confirmed infection, so as to provide data support for the application of ECLIA in blood screening. 【Methods】 177 HIV reactive samples in blood screening testing detected by our laboratory from February to October 2019 were collected, of which 137 were reactiv to isolated ELISA reagent e, 39 to dual ELISA reagent, and 1 in window period. Ten maker-negative samples were randomly selected to undergo ECLIA with the above 177 samples. HIV reactive samples were sent to Centers for Disease Control and Prevention (CDC) for confirmation tests, and the results were analyzed and compared. 【Results】 Among the 177 HIV reactive samples, 66 were ECLIA reactive, 111 negative, and the 10 maker-negative samples remained negative. The sensitivity, specificity, positive predictive value, negative predictive value and total concordance rate of ECLIA were 97.1%, 81.1%, 55%, 99.1% and 84.2%, respectively, showing better performance than that of two ELISA reagents(P0.05). The positive predictive value and specificity were tested by chi-square test, and the difference between ECLIA and reagent 2 was statistically significant (P<0.05). The ECLIA results showed significant correlation with the confirmation results with good consistency(examed by Kappa test). Among the three reagents, ECLIA presented highest accuracy and largest Youden index. 【Conclusion】 ECLIA presents high detection sensitivity, which can improve the detection ability of early HIV infection and shorten the window period of HIV detection, therefore should be popularized in blood screening.

Window period of HIV infection and testing algorithm after exposure / 中华微生物学和免疫学杂志

The window period of HIV infection refers to the time between HIV exposure and quantified and consistent detection of viral markers. The seroconversion window period is the interval between HIV infection and the first detection of antibodies. The eclipse period is the initial phase from HIV infection to reliable detection of HIV RNA. Understanding the window period is the basis for HIV test counseling, helping to provide key information about how soon after HIV exposure the tests and repeat tests should be offered and when the HIV infection can be excluded after negative test results are obtained. It has guiding significance for formulating post-exposure testing algorithm, selecting tests and interpreting test results. This paper introduced the definition of window period, emphasized the main points for accurately understanding the concept, analyzed the factors affecting the window period, especially the impact of antiretroviral drugs on viral marker response and detection, and proposed the follow-up method and post-exposure test strategy based on the length of window period, aiming to provide reference for the diagnosis of acute HIV infection.

Confidential unit exclusion from 2011 to 2020, Xiamen / 中国输血杂志

【Objective】 To investigate and analyze the status quo of confidential unit exclusion(CUE) in Xiamen from 2011 to 2020. 【Methods】 The data of all CUEs in Xiamen Blood Center from January 1, 2011 to December 31, 2020 were collected for statistical analysis. 【Results】 From 2011 to 2020, there were 511 602 blood donations in Xiamen, of which 64 were CUE (0.012%, 64/511 602); A total of 156 U blood was discarded, accounting for 0.17%(156/90 649) The main reason for CUE was " high risk behavior" (56.3%, 36/64); The main groups of CUE were male (70.3%, 45/64), 18~30 years old (60.9%, 39/64), college degree or above (53.1%, 34/64), and first-time blood donors (70.3%, 45/64). However, in terms of the proportion of blood donors, little significant difference in the rate of CUE was notable by age and gender (P>0.05), but by educational background and donation numbers (P<0.05). The anti-HIV positive rate of CUE was 1.56% (1 / 64) and significantly higher than that of non-CUE ( 0.14%, 725 / 511 538) (P<0.001). 【Conclusion】 CUE is one of the important measures to ensure blood safety. It is necessary to strengthen the consultation before blood donation and the popularization of blood safety knowledge after blood donation for specific groups, broaden the way to report after blood donation and improve the level of CUE.

Seven Years Experience in NAT Testing of Blood Donors in a Tertiary Care Centre

Introduction: Nucleic acid amplification testing (NAT) isa very sensitive and specific test for viral nucleic acids.Itreduces the window period for detection of viruses. It is highlybeneficial in countries like India which has a high incidenceand prevelance of transfusion transmitted infections. NATis expected to identify many NAT yield cases which are notdetected by other serological tests.Material and methods: A retrospective analysis oftransfusion transmitted infection (TTI) reactive units in atertiary care hospital was done over a period of seven yearsfrom Jan 2011 to Dec 2018. The blood units were tested byenhanced chemiluminesense technology and Individual donornucleic acid testing (ID- NAT). NAT yield was calculated forHepatitis B, C and HIV.Results: Out of 23,378 collected blood units, 380 units(1.62%) were found to be reactive for one or more transfusiontransmitted viruses by chemilumunisense and/or NAT. 371units (1.58%) were found reactive by chemiluminesense and190 units (0.81%) by NAT. All the NAT yield cases were forhepatitis B virus and it was 9 (1:2597).Conclusion: NAT is more sensitive than chemiluminisense indetection of Hepatitis B. It detects both window period andoccult infection.It has made a significant contribution towardsensuring safe blood transfusion by helping in reduction ofwindow period transmission of Hepatitis B. It is important toimplement NAT in developing countries like India to enhancetransfusion safety.

Detection of HIV-1 infections in blood donors during the pre-seroconversion window period in São Paulo, Brazil

Abstract By decreasing the pre-seroconversion window period, nucleic acid testing (NAT) has improved the safety of blood products and reduced the risk of transfusion-transmitted infections. Between 2011 and 2017, NAT determinations for approximately 898,202 donations were performed at Fundação Pró-Sangue/Hemocentro de São Paulo (FPS-HSP). Three seronegative HIV-viremic donations were detected. The NAT yield rate per million donations was 3.34 for HIV, and the acute HIV-1 infections detected are described, followed by a brief review of the situation in Brazil.

Distribution of bacteria of wound secretion and drug susceptibility analysis in infected patients from Department of Hand Surgery / 吉林大学学报(医学版)

Objective: To analyze the results of bacteria distribution of wound secretion and the drug susceptibility test of the infected patients from Department of Hand Surgery, and to provide the evidence for antibiotic selection in the infected patients in early stage of treatment. Methods: The clincal data of hospitalized patients from Department of Hand Surgery were collected. The patients were divided into three groups according to the wound conditions. The patients in Group 1 who had no wound while being in hospital were infected after operation; the patients in Group 2 had the contaminated wound but no infection while being in hospital; the patients in Group 3 had definite infection while being in hospital. The results of bacterium culture of wound secretion and drug susceptibility test of the patients in three groups were analyzed. Results: The clinical data of 297 patients were obtained, including 17 patients from Group 1, 201 patients from Group 2, and 79 patients from Group 3. A total of 406 strains of 54 species of bacteria were isolated from 297 patients, including 178 strains (43. 84%, 178/406) gram-positive bacteria and 228 strains (56. 2%, 228/406) gram-negative bacteria. The four most common strains were Staphylococcus aureus (15.8%, 64/406), Staphylococcus epidermidis (14.0%, 57/406), Enterobacter cloacae (10.3%, 42/406), and Serratia marcescens (9.9%, 40/406). The results of drug susceptibility test showed that the detection rates of methicillin-resistant staphylococcus aureus (MRSA) and staphylococcus epidermidis were 9. 4% (6/64) and 72. 0% (46/64), respectively. There were no vancomycin-resistant, linezolidresistant, and tigecycline-resistant positive strains among Staphylococcus susceptibility; and there were no the carbapenem-resistant positive strains among Enterobacter cloacae and Serratia marcescens. The susceptibility rate of Enterobacter cloacae to ceftriaxone was 83. 3% (35/42), and its susceptibility to ceftazidime was 90. 5% (38/42). The susceptibility rate of Serratia marcescens to ceftriaxone was 100.0% (40/40), and its susceptibility to ceftazidime was 97.5% (39/40). Conclusion: The first generation of cephalosporin and penicillinase-stabilized penicillin can be used as the preferred empirical antibiotics for the infected patients from Deparment of Hand Surgery in our hospital. The third and fourth generation cephalosporins and quinolones antibiotics can be used as the preferred antibiotics for the infected patients with open trauma as well as the possibility of G- bacillus infection.

Effect analysis of improving the HIV positive detection rate by single sample nucleic acid amplification test in Shenzhen / 国际检验医学杂志

Objective To investigate the effect of improving the human immunodeficiency virus (HIV)posi-tive detection rate by single sample nucleic acid amplification test (SS-NAT) in Shenzhen ,and to explore the effect of SS-NAT on reducing the risk of HIV infection in transfusion .Methods 269 228 blood samples were performed parallel detection by SS-NAT (Procleix Tigris ) and two kinds of enzyme-linked immuno sorbent assay(ELISA)reagents ,and then the samples with nonreactive by ELISA and reactive by SS-NAT were tested by HIV identification assay .The blood donors with reactive HIV identification assay were made tracing tests . All the samples with reactive by ELISA or HIV identification assay were sent to the Shenzhen Center for Dis-ease Control and Prevention (CDC) for Western Blot (WB) diagnostic tests .Results The samples with reac-tive by the third generation ELISA reagents ,the fourth generation ELISA reagents ,both ELISA reagents and SS-NAT were 188 ,340 ,422 and 103 ,which reactive rate was 0 .698‰(188/269 228) ,1 .263‰(340/269 228) , 1 .567‰(422/269 228) and 0 .383‰(103/269 228) ,respectively .We found four samples with nonreactive by ELISA but reactive by SS-NAT .The four donors were found HIV reactive by both ELISA and SS-NAT after tracing .All the samples with reactive by ELISA or HIV identification assay were sent to CDC for confirmatory tests and 103 of them were positive .The positive detection rate of transfusion-transmissible HIV infection af-ter ELISA detection was 1∶67 307(4/269 228) .Conclusion The application of SS-NAT in blood screening can improve the HIV positive detection rate ,shorten window period of HIV detection and reduce residual risk of transfusion-transmissible HIV infection ,and then blood safety can be effectively improved .

Analysis of influencing factors of platelet transfusion during bone marrow empty window period on patients with allogeneic peripheral blood stem cell transplantation / 中国输血杂志

Objective To analyze the influence of different factors and their relating correlation results on platelet transfusion during the bone marrow empty window period on the patients who have undergone allogeneic peripheral blood stem cell transplantation (allo-HSCT) with retrospective analysis of case-control data.Methods Clinical data of 153 cases were collected by the clinical blood management and evaluation information system with discharge diagnosis of allo-HSCT in the hematology department of The First Affiliated Hospital of Nanchang University within a time frame from January 2014 to December 2016.A total of 90 cases were considered valid for retrospective analysis according to the case exclusion criteria.The average transfusion dose for patients with allo-HSCT during the bone marrow empty window period was defined as the threshold value which divided the 90 cases into the observation group of 38 cases receiving more than 6 Units of platelet transfusion and the control group of 52 cases with less than 6Units of platelet transfusion.The amount of platelets transfused during the bone marrow empty window period,clinical indexes include Hb,ANC,Plt,SF before pretreatment,platelet engraftment time and the number of mononuclear cells implanted were compared and analyzed by Logistic regression.Results (1) There was no significant difference between the two groups in gender,age,primary diagnosis,HLA matching,Hb before pretreatment and the number of mononuclear cells implanted (P＞0.05).The ANC(×109/L) (1.24±0.57 vs 3.36±1.33) and Plt(×109/L) (43.55±68.29 vs 126.62±84.73) counts before pretreatment in the observation group were significantly lower than those in the control group(P＜0.05).SF(μg/L) (2351.05 ± 1 587.96 vs 1 000.96± 362.97)before pretreatment and P LT recovery time (d) (16.84± 2.47 vs 12.73 ± 1.65)was significantly higher than that in the control group(P＜0.05).Donor-recipient ABO blood group typing incompatibility (15 vs 10) was significantly higher than the control group (P＜0.05);(2) Single factor Logistic regression analysis showed that ABO blood group matching,clinical indexes include ANC,Plt,SF before pretreatment,PLT recovery time were statistically significant,Only ANC before pretreatment and PLT recovery time had significant effect on the platelet transfusion during bone marrow empty window period in patients with allo-HSCT in multivariate Logistic regression analysis(P＜0.05).Condusion The ANC before pretreatment and PLT recovery time are independent factors for platelet transfusion of the bone marrow empty window period in patients with allo-HSCT.The PLT recovery time is an independent risk factor,which indicates that the longer the duration of PLT implantation,the greater the amount of platelet transfusion will be needed.Besides,the ANC before pretreatment is the independent protective factor,which indicates that the greater the ANC,the smaller the amount of platelet transfusion is required.

Detection of occult HBV infection and probably window period infection among single NAT reactive blood donors / 国际检验医学杂志

Objective To analyze hepatitis B virus(HBV) infection stage in single nucleic acid test(NAT)reactive blood donors.Methods Blood donor samples were screened routinely for HBV DNA by using transcription-mediated amplification(TMA) NAT and quantitative polymerase chain reaction(PCR).Then serum markers of HBV were also detected.The HBV infection stage was analyzed.Results Among the 225 single NAT reactive samples,78(34.67%) were identified to be reactive for HBV DNA by TMA NAT discrimination test and/or PCR test,of which 63(82.89%) were occult HBV infection(OBI),13(17.11%) were probably window period infection(pWP),and 2 cases could not be classified for infection stage.Among the OBI samples,49 samples(77.78%) were with HBV DNA concentration less than 20 IU/mL,whereas,there were only 4 samples(30.77%) in pWP samples.The 225 samples were classified into three groups according to the S/CO of NAT, including 1-<6 group,6-<10 group and 10-17 group, the confirmed HBV DNA positive rates of which were 13.11%,13.64% and 47.18%,and the positive rate of 10-17 group was higher than 1-<6 group and 6-<10 group(P<0.05).In all 63 OBI samples,there were 8(12.70%),3(4.76%) and 52(82.54%) samples were classified into S/CO 1-<6,6-<10 and 10-17,respectively.All of the 13 pWP samples were with NAT S/CO of 10-17.Conclusion Part of single NAT reactive blood donors could be with HBV infection,of which OBI might be popular than pWP, with very low concentration of HBV DNA.Deferral of single NAT reactive blood donors could reduce transfusion-transmitted HBV infection.

Evaluation of HIV diagnosis kits used for blood screening with NIFDC-established HIV-1 seroconver-sion panels / 中华微生物学和免疫学杂志

Objective To establish HIV-1 seroconversion panels with the samples collected by National Institutes for Food and Drug Control ( NIFDC) and to evaluate the window periods of HIV enzyme immunoassay ( EIA) diagnostic kits used for blood screening with them. Methods Serum specimens were collected from different plasma donation stations in China. All suspected HIV infection specimens were screened for HIV by using the nucleic acid amplification testing (NAT), Western blot confirmatory assay and P24 quantitative detection assay. The HIV env gene sequences were amplified by RT-PCR for further confirmation of HIV infection. The PCR products were sequenced and genotyped. The confirmed seroconver-sion panels were used to evaluate the early detection capabilities of the 4th and 3rd generation HIV EIA diag-nostic kits used in blood screening in china. Results A total of 8 sets of HIV seroconversion panels com-prised of 36 samples were confirmed in this study, including 6 sets of AE subtype, 1 set of B subtype and 1 set of unknown genotype. Those seroconversion panels were tested with HIV diagnostic kits produced by 19 different manufacturers. For the early detection of HIV infection, the 4th generation HIV diagnostic kits with a score of 9. 4 points were better than the 3rd generation HIV diagnostic kits whose score was 3. 6 points (P<0. 01, t=8. 547). Some of the domestic 4th generation HIV diagnostic kits were similar to the imported kits in the early detection of HIV infection. In terms of the diagnosis of HIV infection, the HIV-1 NAT was at least 2 weeks earlier than the HIV EIA diagnostic kits. The sensitivity of confirmatory assay was lower than that of the diagnostic kits. Four out of five 4th generation HIV diagnostic kits showed declined signal to cut off ( S/CO ) ratio , indicating the probability of false detection during the second window period . Conclusion Eight sets of NIFDC HIV-1 seroconversion panels were established in this study. With those panels we found that there were differences in the window period between different EIA diagnostic kits used for HIV blood screening.

Study on HIV diagnosis of early detection of infection of three HIV antigen/antibody detection method / 中国免疫学杂志

Objective:Comparison of commercially available three HIV antibody detection kit for HIV infection,found as early HIV infection provides a reference method.Methods:By using two fourth generation HIV Kit ( Murex HIV Ag/Ab Kit:British Abbott company production numbers for A;Holland Organon company Vironostika HIV Uni-Form II Ag/Ab Kit:No.B;) a third generation HIV Kit ( British Abbott company produced Murex HIV-1.2.O Kit:No.C) and P24 antigen detection kit for 3 863 blood samples and BBI positive blood winding detection,sensitivity analysis,the specificity for the two fourth generation HIV kit for detecting,at the same time analysis of three kinds of antibody detection kit for detection of HIV infection window period of time whether the advance.Results:A kit,B were all positive blood samples from 54 patients with HIV infection,the sensitivity of A detection kit=100%,the specificity =99.61%, the rate of missed diagnosis=0, misdiagnosis rate=0.39%;the sensitivity of B detection kit=100%, the specificity =99.37%,the rate of missed diagnosis=0,misdiagnosis rate=0.63%;reagent A and B detection results are compared,the results did not show significant difference (P>0.05) ;A kit,B kit respectively compared with C reagent detection window period ahead of 5.5 and 3.7 d,but compared with P24 antigen kit detection window period was a lag of 4.25 to 6.05 d.Conclusion:In this study,the ability of two fourth generation HIV kit for detection of HIV infection in the strong sensitivity,reached 100%,but can be HIV infection window period in advance,to ensure the safe use of blood.

Reduction of the HIV Seroconversion Window Period and False Positive Rate by Using ADVIA Centaur HIV Antigen/Antibody Combo Assay

BACKGROUND: Early diagnosis of HIV infection reduces morbidity and mortality. Fourth-generation HIV detection assays are more sensitive because they can detect p24 antigen as well as anti-HIV antibodies. In this study, we evaluated the performance of a new fourth-generation ADVIA Centaur HIV antigen/antibody combo (CHIV) assay (Siemens Healthcare Diagnostics Inc., USA) for early detection of HIV infection and reduction of false positive rate. METHODS: Four seroconversion panels were included. The third-generation ADVIA Centaur HIV 1/O/2 enhanced (EHIV) assay (Siemens Healthcare Diagnostics Inc., USA) and fourth-generation CHIV assay were used to test each panel for HIV infection. The presence of antigen was confirmed using HIV p24 antigen assay. To evaluate false-positivity and specificity, 54 HIV false-positive and HIV-negative serum samples from 100 hospitalized patients and 600 healthy subjects were included. RESULTS: Compared to the EHIV assay, the CHIV assay had a shorter window for three of the seroconversion panels: a difference of 10 days and two bleeds in one panel, and 4 days and one bleed in the other two panels. Only 34 of the 54 (63%) samples known to yield false-positive results by EHIV assay had repeatedly yielded reactive results in the CHIV assay. One of the 600 healthy subjects had a false-positive result with the CHIV assay; thus, the specificity was 99.85% (699/700). CHIV accurately determined the reactive results for the HIV-confirmed serum samples from known HIV patients and Korea Food & Drug Administration (KFDA) panels. CONCLUSIONS: The new fourth-generation ADVIA Centaur HIV assay is a sensitive and specific assay that shortens the serological window period and allows early diagnosis of HIV infection.

Sangre segura en ausencia de infecciones virales por VHB, VHC y VIH en período de ventana serológica de donadores

OBJETIVO: Determinar la prevalencia de infecciones virales (VHB, VHC y VIH) en período de ventana serológica en donadores de sangre evaluados con la prueba de ácidos nucleicos (NAT). MATERIALES Y MÉTODOS: Se incluyeron donadores de sangre evaluados de 2008 a 2009 con pruebas serológicas y moleculares del VHB, VHC y VIH. El período de ventana serológica se definió con la prueba de NAT positiva y la prueba serológica negativa. RESULTADOS: Durante un año se evaluaron 47 847 donadores de sangre; no se identificó ningún caso con infección viral (VHB, VHC y VIH) en período de ventana serológica; únicamente se demostró NAT positivo en donadores con pruebas serológicas positivas: 26 de 78 con VHB, 56 de 318 con VHC y 16 de 155 con VIH. CONCLUSIÓN: Este es el primer estudio en México que demostró en donadores de sangre la ausencia de infecciones virales (VHB, VHC y VIH) en período de ventana serológica con la prueba de NAT.

OBJECTIVE: To determine the prevalence of viral infections (HBV, HCV and HIV) in serological window period in blood donors screened with nucleic acid testing (NAT). MATERIALS AND METHODS: We assessed all blood donors from July 2008 to June 2009 at the Central Blood Bank of the Mexican Institute of Social Security. Medical history was made and provided an information brochure and self-exclusion questionnaire. All blood donors were tested with serological tests (Ag-HBVs, Anti-HCV and Anti-HIV) and molecular testing with NAT for HBV, HCV and HIV. The window period was defined with the positive NAT and negative serological test. RESULTS: During one year, we evaluated 47 847 blood donors. None subject was identified with viral infection (HBV, HCV and HIV) in serological window period. Positive serological testing were found for HBV in 78 (0.2 percent), 318 (0.7 percent) for HCV and 155 (0.3 percent) for HIV. Positive NAT was demonstrated only in donors with positive serology: 26 of 78 with HBV, 56 of 318 with HCV and 16 of 155 with HIV. CONCLUSION: This is the first study in México showed no viral infections (HBV, HCV and HIV) during serological window period in blood donors; The medical history and the self-exclusion questionnaire help to improve blood transfusion safety.

Study of nuclei-acid-test(NAT) among volunteer blood donors from Qingdao area / 中国输血杂志

Objective To investigate the residual risks of transfusion-transmitted HBV/HCV/HIV in current donor screening system of Qingdao area.Methods After the ELISA tests(HbsAg,anti-HCV,anti-HIV) were performed,NAT tests of HBV-DNA,HCV-RNA,and HIV-RNA on plasma samples were conducted.Such specimens as have discrepant ELISA and NAT results(N+/E-,or N-/E+) were subject to further follow-up confirmation tests.Results Among 12000 donor samples,no sample with anti-HCV(-)/HCV-RNA(+) or with anti-HIV(-)/HIV-RNA(+) was detected.However,2 individuals were detected as HBsAg(-)/HBV-DNA(+).One donor had negative ELISA test results in HBsAb,HBeAg,HBeAb,and HBcAb at the first screening.But the HBsAg,HBeAg and HBcAb were confirmed positive along with HBV-DNA after 11 weeks.The other donor was negative for HBsAb,HBeAg,and HBeAb but positive for HBcAb.Follow up tests after 3 weeks indicated the same serological results,with a similar low viralload at about 1000 IU/mL.Conclusion Due to the window period and occult HBV infection,current blood donor screening system has some residual risks of transfusion-transmitted HBV.NAT and HBcAb tests should be implemented to reduce the residual risks of transfusion-transmitted HBV.

Evaluation of Usefulness of HIV Ag-Ab Combination Assay Using LG HIV Ag-Ab Plus / 대한수혈학회지

BACKGROUND: Previously developed diagnostic assays to detect antibodies against HIV have difficulties in diagnosing the infected blood prior to seroconversion. Various 3.5 generation HIV diagnostic assays developed in the Republic of Korea also have the same problem. Newly developed LG HIV Ag-Ab Plus (LG Life Science, Seoul, Korea) is the product to overcome this limitation. METHODS: Sensitivity of both LG HIV Ag-Ab Plus and Enzygnost HIV Integral (Dade Behring, Marburg, Germany) were evaluated by using 82 anti-HIV 1 positive samples, 2 anti-HIV 1 group O positive samples (Vital products, Boynton Beach, FL, USA), 25 anti-HIV 2 positive samples, 5 anti-HIV panels (Boston Biomedica, Inc., MA, USA). Specificity of both product were evaluated using 1081 Anti-HIV negative samples (1000 healthy donors, 13 alcoholics sera, 20 end-stage renal disease sera, 20 HBsAg positive sera, 22 anti-HBs antibody positive sera, 6 anti-HCV positive sera). Seroconversion window was evaluated by using 4 seroconversion panels. Intrapersonal and interpersonal reproducibility of the test were also evaluated. RESULTS: Sensitivity of LG HIV Ag-Ab Plus to sera of healthy donor was 99.9% and that to sera of patients with other underlying diseases was 100%. Sensitivity of both LG HIV Ag-Ab plus and Enzygnost HIV integral assays to sera of HIV infected patients was 100%. Sensitivity of LG HIV Ag-Ab Plus to BBI panel was comparable or better than that of Enzygnost HIV Integral. Analysis of window period using seroconversion panels showed no difference between both tests. CONCLUSION: Sensitivity and specificity of LG HIV Ag-Ab Plus was comparable to that of Enzygnost HIV Integral. It also had an excellent result in analysis of window period using seroconversion panels. So, newly developed LG HIV Ag-Ab Plus assay, by using it in screening donated blood, may provide significant contribution in safety of donated blood.

Study on the fourth generation HIV antigen and antibody combination assays reducing the HIV diagnostic window period / 中华检验医学杂志

Objective To compare the ability of the fourth and the third generation HIV assay kits available in Chinese market to detect early HIV infection.Methods 8 BBI HIV seroconversion panels (PRB924,930,940,942,943,944,946 and 948) and 2 National AIDS Reference Lab's HIV seroconversion panels (2004XJ727 and 20505217) were respectively detected with one HIV antigen assay kit,2 fourth generation HIV assay kits and 4 third generation HIV assay kits.The ability of these kits to detect early HIV infection was analyzed and compared.Results For every panel,the fourth generation HIV assay kits could detect HIV-1 infection 4 to 8 days earlier than the third generation kits,and 2 to 4 days later than the antigen kit.The detection ability of different brands of kits was different.Conclusions The fourth generation HIV assay kits could reduce the window period to detect HIV infection.It's meaningful for diagnosing early HIV infection,blood safety and etc.