Performance of Liaison <scp>XL</scp> automated immunoassay platform for blood‐borne infection screening on hepatitis B, hepatitis C, <scp>HIV</scp> 1/2, <scp>HTLV</scp> 1/2 and <i>Treponema pallidum</i> serological markers

Malm, Kerstin; Kragsbjerg, E.; Andersson, Sören

doi:10.1111/tme.12181

Cited by 11 publications

(7 citation statements)

References 10 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Although the present study was unable to assess other screening tests, the literature indicates the high performance of both the Elecsys HTLV-I/II and Abbott Prism HTLV-I/HTLV-II kits (sensitivity, 100%; specificity, >99%) both in samples from blood donors and in other samples obtained from a routine diagnostic service ( 41 ). The DiaSorin Liaison XL recHTLV-I/II kit was also evaluated elsewhere, with high sensitivity and specificity values being reported, similar to the findings for the Architect rHTLV-1/2 test ( 42 – 44 ).…”

Section: Discussionmentioning

confidence: 56%

Performance of Commercially Available Serological Screening Tests for Human T-Cell Lymphotropic Virus Infection in Brazil

et al. 2018

View full text Add to dashboard Cite

Serological screening for human T-cell lymphotropic virus type 1 (HTLV-1) is usually performed using enzyme-linked immunosorbent assay (ELISA), particle agglutination, or chemiluminescence assay kits. Due to an antigen matrix improvement entailing the use of new HTLV antigens and changes in the format of HTLV screening tests, as well as newly introduced chemiluminescence assays (CLIAs), a systematic evaluation of the accuracy of currently available commercial tests is warranted.

show abstract

Section: Discussionmentioning

confidence: 56%

Performance of Commercially Available Serological Screening Tests for Human T-Cell Lymphotropic Virus Infection in Brazil

et al. 2018

View full text Add to dashboard Cite

show abstract

“…Similar results were obtained by Malm K. et . al ., on a blood donor population [ 40 ]. A study conducted by Ghisetti V. et .…”

Section: Discussionmentioning

confidence: 99%

Detection of HBsAg mutants in the blood donor population of Pakistan

et al. 2017

View full text Add to dashboard Cite

BackgroundInfection with the Hepatitis B virus (HBV) continues to be one of the leading healthcare issues in Pakistan, affecting over 6 million people. The existence of HBsAg mutants is well documented in many countries. In Pakistan, HBV screening in the majority of the blood banks is performed by Rapid Detection Devices or ELISA tests. These tests are designed to detect HBsAg, but may not detect the mutant HBsAg. Failure to detect the HBsAg mutant may result in the transmission of HBV infection from donor to recipient. Hence, there is a need to identify a HBsAg assay which can detect mutants in a country where simple and conventional HBsAg assays with varying sensitivity and specificity are used to detect HBV infections.Material and methodsThree routinely used diagnostic tests (Rapid Detection Devices, ELISA and CLIA) for HBsAg were compared with the LIAISON® XL Murex HBsAg Quant Assay to determine the prevalence of HBV mutants in the Pakistani blood donor population.The samples of blood donors from different cities of Pakistan were collected. The testing was performed using SD Bioline rapid assay (n = 1500), ELISA (n = 1500), and Abbott ARCHITECT®CLIA system (n = 1500) at the centers where the donations were collected. All samples (n = 4500) were re-tested for comparative analysis on the LIAISON® XL Murex HBsAg Quant assay (DiaSorin S.p.A.). PCR testing was performed as a gold standard on all discordant samples.Results119/4500 (2.64%) of the samples were positive for antibodies against HBsAg. The sensitivity of SD Bioline Rapid, GB HBsAg ELISA, Abbott ARCHITECT® and LIAISON® XL Murex HBsAg Quant assay was 17.24%, 43.75%, 90.91%and 100% respectively. The specificity of SD Bioline Rapid, GB HBsAg ELISA, Abbott ARCHITECT® and LIAISON® XL Murex HBsAg Quant Assay was 98.82%, 99.59%, 100% and 100%, respectively.ConclusionLIAISON® XL Murex HBsAg Quant assay is a highly sensitive, specific and accurate screening assay for detecting wild type as well as mutant HBsAg.

show abstract

“…CLIA and ECLIA have been proved to be at least as specific and sensitive as common assays in serological detection of many infectious diseases [ 12 – 15 ] but not applied for HIV blood screening in China. CLIA and ECLIA have been used for routine screening among blood donors in the US [ 16 ], Australia [ 17 ], Sweden [ 18 ], and Italy [ 10 ] for many years. Hence, evaluation of ELISA, CLIA, and ECLIA among blood donations is critical for the development of HIV serological screening strategy.…”

Section: Discussionmentioning

confidence: 99%

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

Chang

Zhao

Guo

et al. 2020

Canadian Journal of Infectious Diseases and Medical Microbiolog

View full text Add to dashboard Cite

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.

show abstract

Performance of Liaison XL automated immunoassay platform for blood‐borne infection screening on hepatitis B, hepatitis C, HIV 1/2, HTLV 1/2 and Treponema pallidum serological markers

Abstract: The LIAISON® XL platform demonstrated very high sensitivity for the markers tested and the specificity necessary to fulfil the stringent requirements for blood donor screening.

Cited by 11 publications

References 10 publications

Performance of Commercially Available Serological Screening Tests for Human T-Cell Lymphotropic Virus Infection in Brazil

Performance of Commercially Available Serological Screening Tests for Human T-Cell Lymphotropic Virus Infection in Brazil

Detection of HBsAg mutants in the blood donor population of Pakistan

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

Contact Info

Product

Resources

About