Comparison Between Screening and Confirmatory Serological Assays in Blood Donors in a Region of South Italy

Sommese, Linda; Iannone, Carmela; Cacciatore, Francesco; Iorio, Gustavo De; Napoli, Claudio

doi:10.1002/jcla.21666

Cited by 19 publications

(17 citation statements)

References 21 publications

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“…The overall specificity results reported here were similar for the Elecsys syphilis assay and all other assays tested (Table 2) and compare favorably with those reported in the literature (26)(27)(28)(29)(30)(31)(32)(33)(34)(35)(36)(37)(38)(39)(40), as shown in Fig. 1A.…”

Section: Discussionsupporting

confidence: 89%

Performance Evaluation of the Elecsys Syphilis Assay for the Detection of Total Antibodies to Treponema pallidum

Enders¹,

Hunjet²,

Gleich

et al. 2015

Clin Vaccine Immunol

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Syphilis is a health problem of increasing incidence in recent years that may have severe complications if not diagnosed and treated at an early stage. There are many diagnostic tests available for syphilis, but there is no gold standard, and diagnosis therefore usually relies upon a combination of tests. In this multicenter study, we evaluated the treponemal Elecsys syphilis assay for use in the diagnosis of syphilis in routine samples, i.e., when syphilis is suspected or during antenatal or blood donation screening. The sensitivity and specificity of the Elecsys syphilis assay were compared head to head with those of other treponemal assays used in routine clinical practice and were assessed in potentially cross-reactive samples from patients with Epstein-Barr virus, HIV, and Lyme disease. In a total of 8,063 syphilis-negative samples collected from routine diagnostic requests and blood donations, the Elecsys syphilis assay had a specificity of 99.88%. In 928 samples previously identified as syphilis positive, the sensitivity was 99.57 to 100% (the result is presented as a range depending on whether four initially indeterminate samples are included in the assessment). The specificity of the Elecsys syphilis assay in patients with other infections was 100%; no false-positive samples were identified.

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Section: Discussionsupporting

confidence: 89%

Performance Evaluation of the Elecsys Syphilis Assay for the Detection of Total Antibodies to Treponema pallidum

Enders¹,

Hunjet²,

Gleich

et al. 2015

Clin Vaccine Immunol

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“…The proportion of confirmed active infections among positive screening test results varies widely across studies and test types. The proportion of RNA-positive, active HCV infection cases ranged from 0% to 89.7% among positive antibody-based assays [29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][45][46][47][48][51][52][53][54] and from 0% to 100% among antigen-based assays. 39,44,49,50 Only three studies conducted confirmatory polymerase chain reaction on samples that tested negative for HCV antibody or antigen.…”

Section: Box 1: Grading Of Recommendationsmentioning

confidence: 99%

“…The proportion of negative anti-HCV assays that were confirmed with polymerase chain reaction to be RNA negative ranged from 73.7% to 99.7% for two antibody assays 29,39 and 89.7% in one antigen assay. 32 The wide variation in results may be as a result of actual differences in test performance, varying study sample sizes or underlying variation in population characteristics, including population prevalence.…”

Section: Box 1: Grading Of Recommendationsmentioning

confidence: 99%

Recommendations on hepatitis C screening for adults

2017

CMAJ

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“…Although automated CLIAs are gradually replacing EIAs, data from published studies have compared the results obtained with algorithms that use the two techniques (9, 10, 12, 15–17). It has been reported that the detection of infection markers requires all screening assays to have high levels of sensitivity and specificity (9–11, 18). The present study demonstrated for the first time that the use of an algorithm based on automated CLIAs before GI endoscopy increased the sensitivity of detection of HIV, HCV, and HBV, increased the specificity of detection of HIV, and maintained the specificity of detection of HCV, HBV, and T.…”

Section: Discussionmentioning

confidence: 99%

“…All proposed algorithms should have a high level of sensitivity and specificity for testing for blood-transmitted infections to ensure safety during surgery (9–11). The selection of appropriate algorithms and assays is a critical part of the screening program, and enzyme immunoassays (EIAs) and chemiluminescent immunoassays (CLIAs) are currently the assays that are the most frequently employed in these serological screening algorithms (9–13).…”

Section: Introductionmentioning

confidence: 99%

Screening for Human Immunodeficiency Virus, Hepatitis B Virus, Hepatitis C Virus, and Treponema pallidum by Blood Testing Using a Bio-Flash Technology-Based Algorithm before Gastrointestinal Endoscopy

et al. 2016

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Currently, conventional enzyme immunoassays which use manual gold immunoassays and colloidal tests (GICTs) are used as screening tools to detect Treponema pallidum (syphilis), hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus type 1 (HIV-1), and HIV-2 in patients undergoing surgery. The present observational, cross-sectional study compared the sensitivity, specificity, and work flow characteristics of the conventional algorithm with manual GICTs with those of a newly proposed algorithm that uses the automated Bio-Flash technology as a screening tool in patients undergoing gastrointestinal (GI) endoscopy. A total of 956 patients were examined for the presence of serological markers of infection with HIV-1/2, HCV, HBV, and T. pallidum. The proposed algorithm with the Bio-Flash technology was superior for the detection of all markers (100.0% sensitivity and specificity for detection of anti-HIV and anti-HCV antibodies, HBV surface antigen [HBsAg], and T. pallidum) compared with the conventional algorithm based on the manual method (80.0% sensitivity and 98.6% specificity for the detection of anti-HIV, 75.0% sensitivity for the detection of anti-HCV, 94.7% sensitivity for the detection of HBsAg, and 100% specificity for the detection of anti-HCV and HBsAg) in these patients. The automated Bio-Flash technology-based screening algorithm also reduced the operation time by 85.0% (205 min) per day, saving up to 24 h/week. In conclusion, the use of the newly proposed screening algorithm based on the automated Bio-Flash technology can provide an advantage over the use of conventional algorithms based on manual methods for screening for HIV, HBV, HCV, and syphilis before GI endoscopy.

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Comparison Between Screening and Confirmatory Serological Assays in Blood Donors in a Region of South Italy

Cited by 19 publications

References 21 publications

Performance Evaluation of the Elecsys Syphilis Assay for the Detection of Total Antibodies to Treponema pallidum

Performance Evaluation of the Elecsys Syphilis Assay for the Detection of Total Antibodies to Treponema pallidum

Recommendations on hepatitis C screening for adults

Screening for Human Immunodeficiency Virus, Hepatitis B Virus, Hepatitis C Virus, and Treponema pallidum by Blood Testing Using a Bio-Flash Technology-Based Algorithm before Gastrointestinal Endoscopy

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