Comparative Evaluation and Measure of Accuracy of ELISAs, CLIAs, and ECLIAs for the Detection of HIV Infection among Blood Donors in China

Background. Enzyme-linked immunosorbent assay (ELISA) is the only serological method approved for blood screening in China. Automated chemiluminescence immunoassay (CLIA) and electrochemiluminescence immunoassay (ECLIA) had been used in clinical laboratories but not applied to screen HIV among blood donors. This study aimed to evaluate the performance of ELISA, CLIA, and ECLIA, focusing on the feasibility of CLIA/ECLIA for blood screening. Method. 1029 blood donations from 14 blood centers screened by ELISA were enrolled in the study. All plasma samples were tested by eight ELISA assays in 16 blood centers, followed by the detection of CLIA and ECLIA methods in the National Center for Clinical Laboratories (NCCL), further confirmed by nucleic acid testing (NAT) and Western blot (WB). Results. Of 1029 samples, 136 were confirmed as HIV positive. CLIA and ECLIA assay had similar sensitivities with ELISAs but showed higher specificity (CLIA: 99.1%, 885/893; ECLIA: 99.0%, 884/893), concordance rate (CLIA: 99.2%, 1021/1029; ECLIA: 99.1%, 1020/1029), and positive predictive value (PPV) (CLIA: 94.4%, 136/144; ECLIA: 93.8%, 136/145) than most of ELISA kits (>5 ELISAs) (P<0.05). Kappa values of CLIA (0.967) and ECLIA (0.963) were the highest among all the serologic assays. Among 451 samples with initial ELISA reactivity, 315 were negatives, of which 307 (97.5%) and 306 (97.1%) were detected as nonreactive by CLIA (8 nonspecific reactions) and ECLIA (9 nonspecific reactions), respectively. Conclusion. Compared with ELISA, CLIA and ECLIA are more specific and accurate in detecting HIV antibody/antigen and can keep more nonspecifically reactive donors detected by ELISA. CLIA and ECLIA can be used for the improvement of serological blood screening strategy to avoid the unnecessary loss of blood donors.

Download Full-text

HTLV screening of blood donors using chemiluminescence immunoassay in three major provincial blood centers of China

10.21203/rs.3.rs-17314/v4 ◽

2020 ◽

Author(s):

Junpeng Zhao ◽

Feixue Zhao ◽

Wei Han ◽

Xiaoxuan Xu ◽

Lilin Wang ◽

...

Keyword(s):

Blood Donors ◽

Safety Concern ◽

Enzyme Linked Immunosorbent Assay ◽

Chemiluminescence Immunoassay ◽

Blood Donations ◽

High School Degree ◽

Blood Center ◽

Human T Cell ◽

Confirmatory Tests ◽

Blood Screening

Abstract Background: Human T-cell lymphotropic virus (HTLV) remains a major safety concern for blood supplies. Despite many HTLV positive cases being reported in southeastern China, the detection of HTLV has not been prioritized in routine blood screening. Additionally, data on the prevalence of HTLV infection among blood donors is also limited. The objective of this study was to investigate the prevalence of HTLV among blood donors in three Chinese provinces through their representative blood centers, to evaluate the feasibility of chemiluminescence immunoassay (CLIA) for blood screening.Methods: From November 2018 to March 2019, blood plasma samples were collected from Hebei, Changsha, and Shenzhen blood centers and were screened for the HTLV-1/2 antibody using a CLIA and enzyme-linked immunosorbent assay (ELISA). This was followed by confirmatory tests using INNO-LIA HTLV I/II.Results: A total of 59,929 blood donations were collected and screened for HTLV-1/2. The reactive rate of CLIA and ELISA among donations in the Shenzhen blood center (0.0943%, 27/28, 621) was higher than Hebei (0.0248%, 4/16,144), and Changsha (0.0198%, 3/15,164) (p < 0.05). After confirmation, 3 samples were confirmed as indeterminate for HTLV antibodies, and only one sample from the Shenzhen blood center was confirmed as HTLV-1. The overall prevalence of HTLV-1/2 was 1.67 per 100 000 (1/59,929). The HTLV-infected blood came from a 32-year-old first-time female donor with a high school degree, who belonged to the SHE ethnic minority and was born in the Fujian province.Conclusions: In summary, the overall prevalence of HTLV-1/2 among blood donors in the three blood centers in China remains relatively low. However, blood donations with positive or indeterminate results for HTLV antibodies reminded us of the importance of HTLV screening among blood donors in China.

Download Full-text

HTLV screening using chemiluminescence immunoassay among blood donors in three blood centers in China

10.21203/rs.3.rs-17314/v1 ◽

2020 ◽

Author(s):

Junpeng Zhao ◽

Feixue Zhao ◽

Wei Han ◽

Xiaoxuan Xu ◽

Lilin Wang ◽

...

Keyword(s):

Blood Donors ◽

Confirmatory Test ◽

Enzyme Linked Immunosorbent Assay ◽

Screening Methods ◽

Chemiluminescence Immunoassay ◽

Blood Donations ◽

High School Degree ◽

Blood Center ◽

Human T Cell ◽

Blood Screening

Abstract Background Human T-cell lymphotropic virus (HTLV) remains a concern for blood safety. The detection of HTLV has not yet been applied for routine blood screening in China, even though lots of HTLV positive cases have been reported in southeastern China. However, data on the prevalence of HTLV infection among blood donors is limited. Objective The objective was to investigate the prevalence of HTLV among blood donors in three representative blood centers in China and evaluate the feasibility of chemiluminescence immunoassay (CLIA) for blood screening. Methods From November 2018 to March 2019, blood plasma samples collected from Hebei, Changsha and Shenzhen blood centers were screening for HTLV-1/2 antibody using Lumipulse G HTLV-I/II Immunoreaction Cartridges set (CLIA) and enzyme-linked immunosorbent assay (ELISA), followed with confirmatory test using INNO-LIA HTLV I/II. Results A total of 59929 blood donations were collected and screened for HTLV-1/2. The reactive rate of CLIA and ELISA among donations in Shenzhen blood center (0.0943%, 27/28621) was higher than Hebei (0.0248%, 4/16144) and Changsha (0.0198%, 3/15164) ( P <0.05). After confirmation, 3 samples were confirmed as indeterminate for HTLV antibodies, only 1 sample from Shenzhen blood center was confirmed and typed as HTLV-1. The overall prevalence of HTLV-1/2 was 1.67 per 100,000 (1/59929). The HTLV-infected blood donor was a first female donor at age 32 with high school degree, born in Fujian province, and SHE minority. Conclusion In summary, the overall prevalence of HTLV-1/2 among blood donors in the tree blood centers in China remains relatively low. However, blood donations with positive or indeterminate results for HTLV antibodies found in the study reminded us the importance of HTLV screening among blood donors in China. In the view of HTLV prevalence and cost, all the first-blood donors should undergo HTLV screening as a systematic strategy to reduce the risk of transmission of HTLV through blood transfusion.

Download Full-text

HTLV screening of blood donors using chemiluminescence immunoassay in three major provincial blood centers of China

10.21203/rs.3.rs-17314/v2 ◽

2020 ◽

Author(s):

Junpeng Zhao ◽

Feixue Zhao ◽

Wei Han ◽

Xiaoxuan Xu ◽

Lilin Wang ◽

...

Keyword(s):

Blood Donors ◽

Safety Concern ◽

Enzyme Linked Immunosorbent Assay ◽

Screening Methods ◽

Chemiluminescence Immunoassay ◽

Blood Donations ◽

High School Degree ◽

Blood Center ◽

Human T Cell ◽

Blood Screening

Abstract Background Human T-cell lymphotropic virus (HTLV) remains a major safety concern for blood supplies. Despite many HTLV positive cases being reported in southeastern China, the detection of HTLV has not been prioritized in routine blood screening. Additionally, data on the prevalence of HTLV infection among blood donors is also limited. Objective: The objective of this study was to investigate the prevalence of HTLV among blood donors in three Chinese provinces through their representative blood centers, to evaluate the feasibility of chemiluminescence immunoassay (CLIA) for blood screening. Methods: From November 2018 to March 2019, blood plasma samples were collected from Hebei, Changsha, and Shenzhen blood centers and were screened for the HTLV-1/2 antibody using a CLIA and enzyme-linked immunosorbent assay (ELISA). This was followed by confirmatory tests using INNO-LIA HTLV I/II. Results: A total of 59,929 blood donations were collected and screened for HTLV-1/2. The reactive rate of CLIA and ELISA among donations in the Shenzhen blood center (0.0943%, 27/28, 621) was higher than Hebei (0.0248%, 4/16,144), and Changsha (0.0198%, 3/15,164) ( p < 0.05). After confirmation, 3 samples were confirmed as indeterminate for HTLV antibodies, and only one sample from the Shenzhen blood center was confirmed as HTLV-1. The overall prevalence of HTLV-1/2 was 1.67 per 100 000 (1/59 929). The HTLV-infected blood came from a 32-year-old first-time female donor with a high school degree, who belonged to the SHE ethnic minority and was born in the Fujian province. Conclusion: In summary, the overall prevalence of HTLV-1/2 among blood donors in the three blood centers in China remains relatively low. However, blood donations with positive or indeterminate results for HTLV antibodies reminded us of the importance of HTLV screening among blood donors in China.

Download Full-text

HTLV screening of blood donors using chemiluminescence immunoassay in three major provincial blood centers of China

10.21203/rs.3.rs-17314/v3 ◽

2020 ◽

Author(s):

Junpeng Zhao ◽

Feixue Zhao ◽

Wei Han ◽

Xiaoxuan Xu ◽

Lilin Wang ◽

...

Keyword(s):

Blood Donors ◽

Safety Concern ◽

Enzyme Linked Immunosorbent Assay ◽

Chemiluminescence Immunoassay ◽

Blood Donations ◽

High School Degree ◽

Blood Center ◽

Human T Cell ◽

Confirmatory Tests ◽

Blood Screening

Abstract Background: Human T-cell lymphotropic virus (HTLV) remains a major safety concern for blood supplies. Despite many HTLV positive cases being reported in southeastern China, the detection of HTLV has not been prioritized in routine blood screening. Additionally, data on the prevalence of HTLV infection among blood donors is also limited.Objective: The objective of this study was to investigate the prevalence of HTLV among blood donors in three Chinese provinces through their representative blood centers, to evaluate the feasibility of chemiluminescence immunoassay (CLIA) for blood screening.Methods: From November 2018 to March 2019, blood plasma samples were collected from Hebei, Changsha, and Shenzhen blood centers and were screened for the HTLV-1/2 antibody using a CLIA and enzyme-linked immunosorbent assay (ELISA). This was followed by confirmatory tests using INNO-LIA HTLV I/II.Results: A total of 59,929 blood donations were collected and screened for HTLV-1/2. The reactive rate of CLIA and ELISA among donations in the Shenzhen blood center (0.0943%, 27/28, 621) was higher than Hebei (0.0248%, 4/16,144), and Changsha (0.0198%, 3/15,164) (p < 0.05). After confirmation, 3 samples were confirmed as indeterminate for HTLV antibodies, and only one sample from the Shenzhen blood center was confirmed as HTLV-1. The overall prevalence of HTLV-1/2 was 1.67 per 100 000 (1/59 929). The HTLV-infected blood came from a 32-year-old first-time female donor with a high school degree, who belonged to the SHE ethnic minority and was born in the Fujian province.Conclusion: In summary, the overall prevalence of HTLV-1/2 among blood donors in the three blood centers in China remains relatively low. However, blood donations with positive or indeterminate results for HTLV antibodies reminded us of the importance of HTLV screening among blood donors in China.

Download Full-text

High Human Herpesvirus 8 Seroprevalence in the Homosexual Population in Switzerland

Journal of Clinical Microbiology ◽

10.1128/jcm.36.6.1784-1786.1998 ◽

1998 ◽

Vol 36 (6) ◽

pp. 1784-1786 ◽

Cited By ~ 38

Author(s):

Nicolas Regamey ◽

Gieri Cathomas ◽

Martine Schwager ◽

Marion Wernli ◽

Thomas Harr ◽

...

Keyword(s):

Human Immunodeficiency Virus ◽

Blood Donors ◽

Human Herpesvirus ◽

Human Herpesvirus 8 ◽

Enzyme Linked Immunosorbent Assay ◽

Hiv Positive ◽

Herpesvirus 8 ◽

Immunodeficiency Virus ◽

Swiss Population ◽

Hiv Negative

The seroprevalence of human herpesvirus 8 (HHV-8) in the Swiss population was investigated. By enzyme-linked immunosorbent assay, sera reactive to the recombinant HHV-8 antigen orf 65.2 were found in 24% of human immunodeficiency virus (HIV)-positive patients without and in 92% of HIV-positive patients with Kaposi’s sarcoma. Surprisingly, 20% of homosexual HIV-negative men, versus only 7% of heterosexual HIV-negative individuals and 5% of blood donors, had antibodies to HHV-8.

Download Full-text

Comparative evaluation of enzyme-linked immunosorbent assay with rapid plasma reagin for screening of syphilis in blood donors

Asian Journal of Transfusion Science ◽

10.4103/ajts.ajts_126_17 ◽

2018 ◽

Vol 12 (2) ◽

pp. 165 ◽

Cited By ~ 1

Author(s):

Suchet Sachdev ◽

ArunKumar Sharma ◽

Sunil Sethi ◽

Sachin Garg ◽

DivjotSingh Lamba ◽

...

Keyword(s):

Immunosorbent Assay ◽

Comparative Evaluation ◽

Blood Donors ◽

Enzyme Linked Immunosorbent Assay ◽

Rapid Plasma Reagin

Download Full-text

Immunoreactivity of Tissue Plasminogen Activator and of Its Inhibitor Complexes

Thrombosis and Haemostasis ◽

10.1055/s-0038-1646605 ◽

1989 ◽

Vol 61 (03) ◽

pp. 409-414 ◽

Cited By ~ 70

Author(s):

M Rånby ◽

G Nguyen ◽

P Y Scarabin ◽

M Samama

Keyword(s):

Plasminogen Activator ◽

Tissue Plasminogen Activator ◽

Degradation Products ◽

Gel Filtration ◽

Free Form ◽

Enzyme Linked Immunosorbent Assay ◽

Plasma Samples ◽

Significant Difference ◽

Tissue Plasminogen ◽

Pai 1

SummaryAn enzyme linked immunosorbent assay (ELISA) based on goat polyclonal antibodies against human tissue plasminogen activator (tPA) was evaluated. The relative immunoreactivity of tPA in free form and tPA in complex with inhibitors was estimated by ELISA and found to be 100, 74, 94, 92 and 8l% for free tPA and tPA in complex with PAI-1, PAI-2, α2-antiplasmin and C1-inhibitor, respectively. Addition of tPA to PAI-1 rich plasma resulted in rapid and total loss of tPA activity without detectable loss of ELISA response, indicating an immunoreactivity of tPA in tPA/PAI-1 complex of about l00%. Three different treatments of citrated plasma samples (acidification/reneutralization, addition of 5 mM EDTA or of 0.5 M lysine) prior to determination by ELISA all resulted in increased tPA levels. The fact that the increase was equally large in all three cases along with good analytical recovery of tPA added to plasffi, supported the notion that all tPA antigen present in plasma samples is measured by the ELISA. Analysis by ELISA of fractions obtained by gel filtration of plasma from a patient undergoing tPA treatment identified tPA/inhibitor complexes and free tPA but no low molecular weight degradation products of tPA. Determinations of tPA antigen were made at seven French clinical laboratories on coded and randomized plasma samples with known tPA antigen content. For undiluted samples there was no significant difference between the tPA levels found and those known to be present. The between-assay coefficient of variation was 7 to 10%. In conclusion, the ELISA appeared suited for determination of total tPA antigen in human plasma samples.

Download Full-text