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【Objective】 To establish a magnetic bead enrichment strategy for the detection of human immunodeficiency virus deoxyribonucleic acid (HIV DNA) in peripheral blood, and to verify the improvement of the sensitivity of this method for the detection of HIV DNA in HIV infected patients after early antiretrovital treatment (ART). 【Methods】 Peripheral whole blood was collected at 4 timepoints in one ART HIV window period (WP) patient. Peripheral blood mononuclear cells (PBMCs) were isolated on a Ficoll gradient. CD4+ T lymphocytes were enriched from total PBMCs by negative sorting. HIV DNA concentration in magnetic beads enriched group and whole blood group was detected by HIV DNA detection kit. 【Results】 CD4+ T cells were isolated by magnetic beads and identified by FCM for purity at (96.4 ± 2.6)%. The viability was (95.9 ± 2.9)%, as demonstrated by trypan blue staining. The person on continued ART treatment in this study had significantly greater reduction in HIV viral load and undetectable HIV plasma RNA at follow up timepoint 4. No HIV DNA was detected in the whole blood group at all 4 timepoints. The quantitative results of HIV DNA in the CD4+ T lymphocyte group of the magnetic bead enrichment group were 73.4, 429.3, 137.1, 449.9 copies/106 CD4+ T cell′s respectively. 【Conclusion】 The magnetic bead enrichment method can be more sensitive in detecting the limit low copy HIV DNA in blood samples, and provide early confirmatory data for HIV WP infection and breakthrough infection after ART treatment.
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【Objective】 To analyze the SARS-CoV-2 detection results among blood donors in different periods of COVID-19 pandemic control in Shenzhen and assess the antibody levels and infection status of blood donors in different periods, so as to provide reference for subsequent blood testing strategies. 【Methods】 A total of 4 768 plasma samples of blood donors were subjected to pooled testing by nucleic acid testing(NAT) with 8 samples per pool. Additionally, these samples were subjected to a 1000-fold dilution, and the detection of SARS-CoV-2 total antibody was performed by enzyme-linked immunosorbent assay (ELISA). The 4 768 plasma samples were collected from blood donors at different time points in Shenzhen, with inquiries made to determine whether donors during the COVID-19 pandemic were in the convalescence. The antibody positive rates in blood screening samples during different periods of the pandemic and samples from individuals in the convalescence of COVID-19 infection were analyzed. Furthermore, the antibody levels were examined for differences based on gender, age, and blood type. 【Results】 All 4 768 plasma samples from blood donors were negative by NAT, while 2 342 samples were detected positive by the SARS-CoV-2 total antibody detection, with a positive rate of 49.1%. These samples from four periods (September 30 to October 3, 2022; November 3 to 6, 2022; December 27 to 31, 2022; January 6 to 18, 2023) were subjected to a 1 000-fold dilution for COVID-19 antibody detection, and the positive rates were 21.3%, 15.8%, 65.9%, and 93.9%, respectively. 【Conclusion】 The prevalence of COVID-19 antibodies among blood donors in Shenzhen during different periods of the pandemic varied significantly. There was no difference in antibody prevalence among different genders and blood types, while younger individuals exhibited a higher prevalence of antibodies. The risk of COVID-19 transmission through blood transfusion was found to be extremely low.
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【Objective】 To analyze the results of different methods for reactive samples screened by the enzyme linked immunosorbent assay (ELISA) against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in blood donors. 【Methods】 From March to April 2020, a total of 8 632 blood samples in Shenzhen were screened for SARS-CoV-2 total antibodies (TAb, including IgG, IgM, IgA) in plasma using ELISA(PC group), the antibody reactivity samples and their follow up plasma samples (FC group), and samples of disease control group(DC group) from January to April 2020 were detected using the following methods: 1) ELISA method for detecting IgG, IgM, and (or without detection) TAb; 2) pseudovirus neutralizing antibody test(pVNT); 3) western blot (WB) of SARS-CoV-2 antibody. The negative control group(NC group) from February to April 2020 performed ELISA and WB testing. 【Results】 Among the 34 total antibody positive samples, 2 were positive for pVNT test, and the total antibody, IgG and WB in the initial screening and tracking testing were positive. Thereafter, it was determined to be confirmed positive. The other 2 cases were positive for pVNT test, while the samples with positive WB results were in the follow-up stage. The TAb, IgG, and pVNT results did not conform to the dynamic evolution of antibodies, and cannot be determined as confirmed positive. 【Conclusion】 The infection status of antibody reactivity samples screened by SARS-CoV-2 ELISA can be judged by the logic of pVNT, WB and the dynamic change of antibody.
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【Objective】 To establish a routine screening method for unexpected antibodies of blood donors, analyze the results of centralized screening for unexpected antibody of blood donors in the blood center, and compare the cost of centralized and decentralized screening modes. 【Methods】 A total of 35 591 blood donors were screened for unexpected antibodies from March 31, 2021 to July 31, 2021, using microcolumn gel method. Unexpected antibody screening reactive samples were further confirmed by the Transfusion Research Institute of Shenzhen Blood Center, and the demographic characteristics were further determined through the analysis of unexpected antibody positive population. The direct cost and indirect cost of centralized and decentralized unexpected antibody screening mode were compared. 【Results】 Forty unexpected antibody positive samples were confirmed in Shenzhen, with the positive rate at 0.11%(40/35 591), among which MNS, Rh and Lewis system accounted for 35% (14/40), 32.5% (13/40) and 17.5% (7/40), respectively. Males and females accounted for 45% (18/40) and 55% (22/40), respectively (P0.05). Unexpected antibody screening in a centralized way saved about 1.16 million yuan per year. 【Conclusion】 It is necessary to carry out unexpected antibody screening for all blood donors, and centralized screening is more economical than decentralized screening.
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【Objective】 To establish scrap indicators for key equipment in blood screening laboratory of blood centers and quantitatively assess the running status of key equipment, so as to provide a scientific method for equipment scrap. 【Methods】 Through the literature review and Delphi method, the scrap indicators of key equipment in blood screening laboratories were established in terms of applicability, economy and advancement of the equipment. The weights of relevant indicators were calculated by analysis hierarchy process (AHP), and the quantitative assessment model of equipment scrap priority was established according to the indicators and its weight. The equipment running data from January 2020 to December 2020 of Laboratory Department were collected and analyzed using the model, and its accuracy was verified based on experience. 【Results】 Thirteen second-level scrap indicators were established, and the weights of the three first-level indexes of applicability, economy and advancement were 0.582, 0.114 and 0.306, respectively. Among the total 30 key equipment, the model score of 4 equipment was less than 0.5, and the running status after manually checking met the scrap standard. 【Conclusion】 The model can accurately assess the scrap priority of key equipment and facilitate the procurement budget and scrapping identification in advance, which can avoid the waste of resources and ensure safe, efficient and orderly laboratory work.
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【Objective】 To investigate the prognosis of blood donors with occult hepatitis B virus infection (OBI) by long-term follow-up and repeated testing of HBsAg and HBV DNA. 【Methods】 From January 1, 2010 to December 31, 2020, voluntary blood donors were screened by both serological and viral nucleic acid(NAT) testing, then samples were further confirmed as HBV DNA positive by manual nested-PCR amplification.A total of 306 cases were detected as HBsAg negative /HBV DNA positive, then followed-up for a long time and re-examined of HBsAg and HBV DNA to confirm whether they had infected with OBI.The prognosis of patients with OBI who experienced long-term immunization was determined by repeated testing. 【Results】 A total of 306 HBsAg negative/ HBV DNA positive blood donors had been followed up, and 40(13.07%, 40/306) were recalled frequently for re-examination.Among them, 90%(36/40), 57.5%(23/40), 40% (16/40)were anti-HBc + , anti-HBs + and anti-HBe + , respectively, and 50%(20/40), 40%(16/40), 7.5%(3/40) and 2.5% (1/40)were anti-HBs+ / anti-HBc + , anti-HBc + / anti-HBs -, anti-HBc -/ anti-HBs + and anti-HBc -/ anti-HBs -, respectively.Those 40 blood donors were followed-up for 1-13 times, with the duration of 8-108 months (0.6~9 years).1 donor (2.5%) was followed-up less than 1 year, 11 (27.5%)>1 year and ≤3 years, 23 (57.5%) 23(57.5%)>3 years and ≤5 years, and 5 (12.5%) for more than 5 years.After long-term following up and repeated testing, 50%(20/40)of OBI blood donors turned negative for HBV DNA (HBsAg negative / HBV DNA negative), 42.5% (17/40)were confirmed as OBI infection (HBsAg negative / HBV DNA positive), and 7.5%(3/40) were hard to determine (after repeated testing, the results were either positive or negative). 【Conclusion】 After long-term following up and repeated screening, we found that none of the OBI patients turned into acute or chronic HBV infection, and most of them maintained OBI.However, OBI blood donors carry very low load of HBV DNA for a long time, which could lead to false negative results of NAT and bring a great challenge to the safety of blood transfusion.
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【Objective】 To analyze the cost-effectiveness of ELISA grey area strategy through establishing the health economics model. 【Methods】 The serological grey area strategy evaluation model was composed of screening strategy subdecision tree, pathogen infection subdecision tree and pathogen detection subdecision tree. The key parameters in the model were obtained from literatures and research data. The cost-effectiveness of setting ELISA grey area strategy was compared by software, and multifactor sensitivity analysis was conducted. 【Results】 After setting the ELISA grey area, extra samples(5.86 cases/100 000) with serological false negativity could be detected, including HBV samples at 4.93/100 000, HCV samples at 0.27/100 000, HIV samples at 0/100 000, syphilis samples at 0.66/100 000. To yield an additional seropositive sample out of every 100 000 blood donors, blood center will afford extra 1 million yuan about. 【Conclusion】 Through this study, a cost-effectiveness evaluation model of serological detection strategy was established. Although the ELISA grey area setting can yield a small number of seropositive samples, the cost is much higher than the current affordability.
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【Objective】 To evaluate the performance and clinical application of a high-throughput nucleic acid blood screening detection system for SARS-CoV-2, so as to provide basis and technical means for its application in detection of plasma from recovered COVID-19 patients. 【Methods】 The SARS-CoV-2 nucleic acid was detected by real-time fluorescence quantitative PCR, and the sensitivity, precision, anti-interference and other parameters were evaluated. Blood donor samples collected during COVID-19 epidemic period were screened using the detection system to evaluate its applicability. 【Results】 The detection limits of gene N and ORF 1ab were 3.98 copies/mL and 9.38 copies/mL, respectively. The CV of high and low concentration samples were both less than 5%. Hemoglobin at 500 mg/dL and triglyceride at 3g/dL had little effect on the results. The detection system can effectively prevent carryover, thus avoiding false positive results. The SARS-CoV-2 nucleic acid blood screening was carried out in a total of 39 306 blood samples, and all samples were negative. 【Conclusion】 The established method can meet the needs of SARS-CoV-2 nucleic acid screening therefore ensure the safe application of plasma from recovered COVID-19 patients.
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【Objective】 To assess three severe acute respiratorysyndrome coronavirus 2 (SARS-CoV-2) enzyme linked immunosorbent assays (ELISA) and one pseudotype lentivirus-based neutralization test (ppNAT) in detecting the convalescent plasma antibody levles from COVID-19. 【Methods】 30 COVID-19 convalescent plasma samples were screened for antibodies against SARS-CoV-2 using three kinds of SARS-CoV-2 ELISA reagents and one ppNAT test in Shenzhen. The controls consisted of plasma samples from 32 healthy blood donors in February 2019. The diagnostic efficacy analysis of various SARS-CoV-2 ELISA reagents was performed using real-time fluorescent Polymerase Chain Reaction (RT-PCR). We also analyzed correlation between different immunological reagents and the age, gender, hospitalization, and severity of illness. 【Results】 The positive yielding rate of ppNAT and three kinds of IgG ELISA was higher than that of IgM ELISA. The positive yielding rates of three kinds of IgG ELISA were 100%(30/30), 93.33%(28/30), and 96.67%(29/30) respectively, while the yielding rates in control group were all 0. The positive yielding rate of three IgM ELISAs were 93.33%(28/30), 70%(21/30)and 46.67% (14/30). All the cases from negative control group were negative for IgG and IgM. Pearson correlation coefficient was calculated; there was a strong correlation between ELISA reagent 2 IgG and ELISA reagent 3 IgG (r=0.765, P0.05). 【Conclusion】 In the convalescent plasma with nucleic acid confirmed covid-19, the yielding rates of different IgM antibodies varied greatly. Antibody levels were influenced by age to some extent.
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【Objective】 To analyze the viability of 2 different blood screening strategies against SARS-CoV-2 in low risk populations, so as to provide references for the formulation of blood screening strategy. 【Methods】 Two screening strategies for antibodies against SARS-CoV-2 were adopted: 1) the total antibody were initially screened for all samples, and the antibody IgG and IgM were retested in those primary positive samples; 2) only antibody test of IgG and IgM for all samples. And SARS-CoV-2 nucleic acid was detected in parallel. Reactive samples was confirmed by neutralization test. The sensitivity, specificity and true positive rate of two strategies were calculated. 【Results】 None was positive for SARS-CoV-2 nucleic acid among 880 samples. Four truly positive samples were implicated in 9 (1.02%, 9/880) initially reactive samples in total antibody test; 3 in 26 (2.95%, 26/880) initially IgG or IgM reactive samples. 【Conclusion】 The first strategy is superior to the second strategy in the sensitivity and specificity, and is recommended for the detection of SARS-CoV-2 antibody in low risk populations.
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【Objective】 To investigate HBV infection with low level of HBsAg and nucleic acid testing(NAT) non-reactive results in blood donors, and analyze molecular characteristics. 【Methods】 Low level HBsAg but NAT-nonreactive samples were collected and tested for HBsAg by Abbott chemiluminescent microparticle immunoassay (CMIA)., HBsAg, anti-HBs, HBeAg, anti-HBe and anti-HBc were further detected by Roche electrochemiluminescence immunoassay(ECLI). BCP/PC and S regions were also amplified by Nested-PCRs and qPCR for HBV DNA quantity were adopted simultaneously. 【Results】 Of 100 363 donations, 60(0.054%) low level HBsAg and NAT-nonreactive blood samples were enrolled the study. In which, 54/60(90%) and 57/60(95%) were WanTai HBsAg ELISA and DiaSorin HBsAg ELISA reactive respectively. Of 33 cases genotyped, genotype B were 87.9%( 29/33), including adw2 96.6%(28/29) and adw1 3.4%(1/29), C was observed in 4(12.1%) with sero-type adrq+. Mutations in S gene of genotype B such as Q101R, Q129H, T131I, M133L/T, F134L, G145R, V168A, L175S and V177A were observed as notable mutations, which can affect HBsAg diagnosis. A high frequency mutation C1799G(87.5%, 21/24)were detected in BCP/PC and would reduce the replication of virus. The median viral load measured by qPCR was 49.6(0~628)IU/mL. 【Conclusion】 A small part of donations with low-level HBsAg and NAT-nonreactive can not be deferred by one isolated ELISA screening assay. It is necessary to apply more sensitive and specific HBsAg assays and NAT in blood screening, and improve the ability to detected mutants.
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【Objective】 To validate the performance of enzyme-linked immunosorbent assay (ELISA) for the detection of antigens and antibodies for blood-borne diseases, so as to meet the requirements of blood screening laboratories. 【Methods】 The reproducibility, precision, sensitivity, specificity, conformance and detection limit of ELISA reagents under different detection procedures were verified according to relevant standards and reagent instructions. 【Results】 The performance verification results of the test procedures were in line with the relevant standards and laboratory requirements. 【Conclusion】 The performance of ELISA method can meet the relevant standards and requirements, as well as the application requirements of the laboratory. Through the analysis and comparison of the performance verification data, the blood screening laboratory can better understand the performance indicators of the detection system, continuously improve the performance of the detection system, and ensure the safety of clinical blood use.
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【Objective】 To track and evaluate the clinical diagnostic efficacy of an enzyme linked immunosorbent assay (ELISA) kit for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). 【Methods】 Total antibody (TAb) specific to SARS-CoV-2 in blood donors were determined using ELISA reagent. TAb positive donors were followed up 1 month after blood donation. SARS-CoV-2 specific IgG, IgM and pseudotype lentivirus based neutralization test (ppNAT) were conducted for TAb positive blood donors and follow-up samples. ppNAT and IgG antibodies simultaneously positive in ppNAT positive samples and its follow-up samples was used as the standard for antibodies validation. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy and Youden index of SARS-CoV-2 TAb ELISA were analyzed. 【Results】 Among 16 016 blood donors from January 31 to April 28, 2020, 61 donors were diagnosed as TAb positive, 6 cases were positive for ppNAT, in which 2 were positive for both ppNAT and IgG; 4 of 46 TAb positive follow-up samples were positive for ppNAT, in which 2 were positive for IgG simultaneously. The sensitivity, specificity, PPV, NPV, accuracy, Youden index, false positive rate and false negative rate of SARS-CoV-2 TAb reagent were 100.00%, 99.60%, 3.28%, 100.00%, 99.60%, 99.60%, 0.40% and 0.00%, respectively. 【Conclusion】 SARS-CoV-2 TAb ELISA has high sensitivity and good clinical diagnostic efficacy, but the false positive rate is relatively high in low-risk blood donors. Therefore, ppNAT, IgG and follow-up results should be fully considered in clinical in order to analyze the positive results and determine the infection status more accurately.
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【Objective】 To investigate NAT non-reactive results implicated in HBsAg ELISA reactive voluntary blood donors in Shenzhen. 【Methods】 HBsAg ELISA+ but NAT-blood samples were collected, and HBsAg was further retested by TRFIA, Roche ECLIA and neutralization test. HBV DNA of individual donation was detected by commercial Roche MPX and Uultrio Elite, and virus nucleic acid was extracted via 2.5 mL. Molecular characterizations of HBsAg+ /NAT-samples were determined by quantitative polymerase chain reaction(qPCR) and nested PCR amplifification of the precore and core promoter regions and HBsAg(S) region. HBV serological markers were detected, and the samples with suspicious results were followed up and detected by multi-assay. 【Results】 Among 67 602 samples, 73(0.11%) HBsAg ELISA+ and NAT-blood samples were enrolled in the study. 15(20.5%, 15/73) were confirmed HBsAg+ by TRFIA, ECLI and five alternative DNA assays, and the other 2(2.7%, 2/73) were further identified as HBsAg+ by follow-up study. In 17 confirmed HBsAg+ samples, the viral loads ranged undetectable to 378 IU/mL, with the median of 10.1 IU/mL. Weak correlation was found between HBsAg and HBV DNA load(R2=0.394 4). 【Conclusion】 Some Hepatitis B virus infected blood samples may miss even with different HBsAg assays. Multi-assays with high sensitivity should be combined for blood screening to ensure blood safety..The inconsistent results should be followed up and further tested for hepatitis B serological markers to assist the confirmation.
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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 .
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Objective To investigate the application value of contrast-enhanced ultrasound(CEUS) time-intensity curve in the radiofrequency ablation treatment of hepatocellular carcinoma.Methods Seventy-six patients with hepatocellular carcinoma (118 tumor lesions) conducted the ultrasound-guided radiofrequency ablation therapy.The acoustic quantitative analysis software was employed to dynamically analyze the residual ablation lesions,which were compared with the examination results of synchronous enhanced MRI,with the pathology as the gold standard,the benign and malignant tumor residual ablation lesions were performed the statistically comparative analysis.Results The accuracy of CEUS effect after liver radiofrequency ablation therapy was 82.2 ％,which of enhanced MRI was 83.9 ％;the difference between CEUS and enhanced MRI had no statistical significance(P＞ 0.05),their examination results had higher consistency;the benign residual ablation lesions after radiofrequency ablation had blood perfusion characteristics different from malignant residual lesions,the time-intensity curve showed that IMAX benign residual lesions were smaller than malignant residual lesions(P＜0.01).The benign residual lesions of RT and TTP were longer than the malignant residual lesions(P＜0.01);diagnosing benign and malignant had no statistical difference between CEUS and enhanced MRI (P＞0.05).Conclusion CEUS combined with the time-intensity curve can dynamically,intuitively and quantitatively reflect the blood perfusion differences among inactivated focus,benign and malignant residual lesions,and the surrounding liver parenchyma.
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Objective To investigate the application value of contrast-enhanced ultrasound(CEUS) time-intensity curve in the radiofrequency ablation treatment of hepatocellular carcinoma.Methods Seventy-six patients with hepatocellular carcinoma (118 tumor lesions) conducted the ultrasound-guided radiofrequency ablation therapy.The acoustic quantitative analysis software was employed to dynamically analyze the residual ablation lesions,which were compared with the examination results of synchronous enhanced MRI,with the pathology as the gold standard,the benign and malignant tumor residual ablation lesions were performed the statistically comparative analysis.Results The accuracy of CEUS effect after liver radiofrequency ablation therapy was 82.2 ％,which of enhanced MRI was 83.9 ％;the difference between CEUS and enhanced MRI had no statistical significance(P＞ 0.05),their examination results had higher consistency;the benign residual ablation lesions after radiofrequency ablation had blood perfusion characteristics different from malignant residual lesions,the time-intensity curve showed that IMAX benign residual lesions were smaller than malignant residual lesions(P＜0.01).The benign residual lesions of RT and TTP were longer than the malignant residual lesions(P＜0.01);diagnosing benign and malignant had no statistical difference between CEUS and enhanced MRI (P＞0.05).Conclusion CEUS combined with the time-intensity curve can dynamically,intuitively and quantitatively reflect the blood perfusion differences among inactivated focus,benign and malignant residual lesions,and the surrounding liver parenchyma.
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Objective To detect the reactive samples of enzyme-linked immunosorbent assay (ELISA1) by chemiluminescence microparticle immunoassay (CMIA),and to analyze the application value of CMIA in HCV infection validation of blood donors.Methods Nucleic acid 3-item combined testing (NAT),another ELISA2,HCV antibody supplementary test(Western Blot test,WB) and CMIA test supplemented in blood samples of 102 ELISA1 anti-HCV reactive blood donors were retrospectively analysed.Results Among 102 blood donors of anti-HCV positive,32 cases (31.37%,32/102) were HCV RNA reactive samples,50 cases (49.02%,50/102) were ELISA2/WB reactive simultaneously.With CMIA NAT results as the reference standard,CMIA was poorly correlated with HCV RNA (Spearman correlation coefficient rs=0.395,P<0.01),and the consistency between them was weak by Kappa test (Kappa=0.270,P<0.01).With ELISA2/WB detection results as the reference standard,CMIA was highly correlated with the results(Spearman correlation coefficient rs=0.713,P<0.01),and which showed high consistency by Kappa test (Kappa=0.674,P<0.01).Conclusion CMIA as a detection method of protein label after HCV infection has great value in the HCV infection confirmation in low-risk population.
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Objective To compare the value of transvaginal ultrasound and MRI in diagnosis of the first-trimester cesarean scar pregnancy (CSP).Methods The transvaginal ultrasound and MRI data of 28 patients who were initially diagnosed as CSP were analyzed. Regarding the surgery and postoperative pathology as a gold standard,the differences between transvaginal ultrasound and MRI were compared in the sensitivity,specificity,diagnostic coincidence rate and the ability in showing the internal structure of gestational sac and its relationship with the surrounding tissue.Results 22 CSP patients were confirmed by surgical pathology in a total of 28 patients,while 20 CSP patients using transvaginal ultrasound and 1 9 using MRI were correctly diagnosed respectively,and the sensitivity,specificity and diagnostic coincidence rate were 90.9%,50.0%,82.1% vs 86.4%,83.3%,85.7%,respectively,exhibiting no statistical difference in the coincidence rates between two methods (χ2 =0.132,P=0.72 ).The pregnant bursa in 20 patients was found by pathology in 22 CSP patients,and 19 pregnant bursa with transvaginal ultrasound and 17 with MRI were confirmed respectively,exhibiting no statistical difference between two methods (χ2 =1.11,P =0.29).The yolk sac in 12 patients,embryos in 8,original heart tube in 5 and local scar pregnancy sac infiltration in 3 were found with transvaginal ultrasound,meanwhile those in 2,2,0 and 9 respectively were also found with MRI,exhibiting significant differences between the two methods (χ2 =13.8,P =0.000;χ2 =7.7,P =0.006;χ2 =7.2,P =0.007;χ2 =7.1,P=0.008).The pregnancy capsule hemorrhage in 7 patients and hemorrhage in uterine cavity in 9 were found with transvaginal ultrasound, meanwhile those in 14 and 1 5 were found with MRI,exhibiting significant differences (χ2 =6.6,P =0.01;χ2 =5.0,P =0.026). Conclusion The coincidence rate in diagnosis of CSP using transvaginal ultrasound or MRI is higher.Transvaginal ultrasound is superior to MRI in showing the yolk sac,embryos and original heart tube,while MRI is better than transvaginal ultrasound in showing the hemorrhage of uterine cavity or gestational sac and the relationship between pregnant bursa and the surrounding tissue.Combination of the two methods shows more value in early diagnosis of CSP.
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Objective To investigate the detection mode for those unpaid blood donors screening as positive HBsAg+ and/or positive anti-HCV could be permitted to recall again for re-detection under the regulation condition in order to determine whether or not regain their qualifications of donating blood and rejoin the blood donation again.Methods The unpaid blood donors preliminari-ly screening as positive HBsAg and/or positive anti-HCV in Shenzhen from Otcober 2007 to December 2013 and conforming to the rules for recalling to re-detection formulated by our center were analyzed and researched for conducting the feasibility discussion on the rejoin mode of unpaid blood donors.Results A total of 415 759 case-times of blood donation were conducted during 2007 ~2013.Among them,2 506 cases(0.60%)and 1 357 cases(0.33%)were screened as positive HBsAg or positive anti-HCV,respec-tively.The recall process of rejoin re-detection was initiated in 59 positive HBsAg donors and 16 positive anti-HCV donors with many times of blood donation.But only 31 positive HBsAg donors and 9 positive anti-HCV donors successfully completed the detec-tion items of re-detection process.Among them 29 positive HBsAg donor regained the qualifications of donating blood and 2 cases were shielded for the blood donation qualification due to unqualification in the following detection.All of the 9 recalled donators with positive anti-HCV regained the blood donation qualification.Conclusion Under present detection mode,the detection tech-nique of blood screening is hard to avoid the occurrence of false positive results caused by the reagents,instruments and personnel operating.In order to protect the donation qualifications of the unpaid blood donators,a set of scientific,reasonable and practical re-detection mode for rejoin of the blood donators should be established for protecting the limited blood donation resource.