Threshold value of LIAISON XL anti‐HCV screening assay predicting positive immunoblotting results

Paschale, Massimo De; Manco, Maria Teresa; Arpino, Olivia; Ricucci, Valentina; Paganini, Alessia; Belvisi, Laura; Cagnin, Debora; Cerulli, Teresa; Cianflone, Annalisa; Agrappi, Carlo; Mirri, Paola; Clerici, Pierangelo

doi:10.1002/jmv.24831

Cited by 3 publications

(3 citation statements)

References 33 publications

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“…Widely implemented to aid in the diagnosis of hepatitis C virus infection, signal strength ratio cutoffs are used to predict positivity to additional tests (9)(10)(11)(12). Just as we suggest for syphilis, that is a valuable means of minimizing the number of samples that require additional (confirmatory) tests.…”

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Using Treponemal Assay Signal Strength Cutoff Ratios To Predict Syphilis Infection

Bristow

Klausner

2018

J Clin Microbiol

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Syphilis screening with the reverse algorithm, a treponemal test for screening followed by a nontreponemal test if reactive, is increasingly being used. That algorithm has several advantages, including use of an automated screening test, saving on laboratory time and costs, as well as detection of very early syphilis infection. However, under that algorithm, in situations where the treponemal result is positive and the nontreponemal result is nonreactive a second treponemal test must be performed, which may actually lead to inefficiencies in the laboratory. In this issue of the Journal of Clinical Microbiology, Y. F. Fakile et al. (J Clin Microbiol 56:e01165-17, 2017, https://doi.org/10.1128/ JCM.01165-17) report the results of their study, which demonstrates the capability of signal strength ratio cutoffs for automated treponemal immunoassays to predict the outcome of repeat treponemal testing. Their findings suggest that anti-treponemal signal strength ratio values above a cutoff value can be used in lieu of repeat treponemal tests.KEYWORDS syphilis, diagnostics, treponemal testing S yphilis is on the increase in the United States. Reported rates of primary and secondary syphilis are the highest that they have been in more than 20 years and are increasing each year across the country and among almost every race/ethnicity and age group (1). There is an urgent need for new paradigms for the use of existing syphilis diagnostic tests.The reverse algorithm for syphilis screening is being used in many settings. (2). That algorithm allows for use of an automated or semiautomated screening test, which can reduce labor requirements and may have particular advantage in high-throughput laboratory settings. An additional advantage is that that algorithm may identify early syphilis infection in which nontreponemal antibodies are not yet detectable (3) or latent syphilis cases when nontreponemal antibodies are no longer detectable. Those early and latent cases would be undetected under the standard algorithm where RPR (or other nontreponemal tests) is used as the screening test. However, using the reverse algorithm, to address the potential of false-positive treponemal test results in cases where the nontreponemal tests are used as confirmatory tests and are nonreactive, the Centers for Disease Control and Prevention (CDC) recommends use of a second treponemal test to confirm the first reactive treponemal result (4). That need for a third assay increases cost and laboratory time and importantly may delay time to result. In an era of increasing syphilis, we want to decrease time to result and subsequent treatment delays as much as possible. Accepted manuscript posted online 18 October 2017Citation Bristow CC, Klausner JD. 2018. Using treponemal assay signal strength cutoff ratios to predict syphilis infection. J Clin Microbiol

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confidence: 99%

Using Treponemal Assay Signal Strength Cutoff Ratios To Predict Syphilis Infection

Bristow

Klausner

2018

J Clin Microbiol

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“…For the VITROS (Ortho) system, the specific S/C ratio under which a supplemental test is recommended is 8.0 [Centers for Disease Control and Prevention, ]. For LIAISON® XL (DiaSorin) system, the proposed S/C ratio is 3.5 [De Paschale et al, ]. In this study, the S/C ratio of the re‐tested positive, but negative to immunoblot samples was always <3.5 for LIAISON® XL and <8.0 for VITROS.…”

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confidence: 54%

Evaluation of LIAISON® XL system for HBsAg, and anti‐HCV and anti‐HIV/Ag p24

Paschale¹,

Manco²,

Belvisi³

et al. 2016

Journal of Medical Virology

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The aim of this study was to compare the data obtained using the new LIAISON® XL chemiluminescence system to search for HBsAg, anti-HCV, and anti-HIV1-2/p24 Ag with those obtained using the VITROS system currently adopted by the Microbiology Unit of the Hospital of Legnano. Routine samples of patients who were referred by practitioners for the determination of HBsAg (1,000 samples) and/or anti-HCV (1,002 samples) and/or anti-HIV1-2 (995 samples) were simultaneously analyzed using both systems. The concordant positive and discordant samples were re-examined for confirmation by means of an HBsAg neutralization assay, anti-HCV immunoblot, or anti-HIV1-2 Western blot; HBV-DNA, or HCV-RNA or HIV-RNA was also sought in the discordant samples. Samples of patients known to be positive were tested (100 HBsAg positive, 100 anti-HCV positive, and 100 HIV 1-2 positive) as well throughout treatment, with viremia levels becoming undetectable after treatment. The HBsAg, anti-HCV, and anti-HIV1-2 concordance between the two systems in routine series was respectively 99.8%, 98.5% and 99.7%, and 100% for all markers in samples known positive. The various molecular biology and confirmatory tests of the discordant samples were all negative (except for one anti-HCV positive sample). Measure of Cohen's kappa coefficient for HBsAg, anti-HCV, and anti-HIV gave K values of respectively 0.992, 0.946, and 0.980. In conclusion, the performance of the LIAISON® XL system in the routine laboratory determination for all three markers was comparable with that of the VITROS system. J. Med. Virol. 89:489-496, 2017. © 2016 Wiley Periodicals, Inc.

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“…However, both of these procedures currently have certain limitations: Anti-HCV usually appears and can be detected 70 days or more after infection, so it cannot be used for early diagnosis of HCV infection. 12 Anti-HCV exists in the body for a long time, and even after HCV has been cleared from the body, anti-HCV can still be detected. Therefore, anti-HCV positivity cannot confirm whether the patient has a current infection or a previous infection.…”

Section: Discussionmentioning

confidence: 99%

Resistant-Associated Substitutions Do Not Affect HCV RNA and HCV Core Antigen Clearance During Direct-Acting Antiviral Agent Treatment in a Real-World Setting

Chen¹,

Liu²,

Kang³

et al. 2022

IDR

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Background: Since oral direct-acting antiviral agents (DAAs) became available, the global hepatitis C treatment situation has undergone tremendous changes. However there are still many issues worthy of attention in treatment. Methods: We selected 53 HCV-infected patients who were treated and followed up in the Peking University First Hospital from December 2017 to January 2021 to detect the RASs in HCV. Pearson correlation analysis was used to analyze HCV RNA and HCV cAg, the Fisher exact test and chi-square test was used to compare the effects of RASs on the rate of decline of HCV RNA and HCV core antigen (cAg) during DAA treatment. Results:The RASs and its prevalence on the NS3 are mainly Y56F 2.56% (1/39), Q80K 23.08% (9/39), S122G 71.79% (28/39), and V170I 38.46% (15/39). On the NS5A were R30Q 10.53% (4/38), P32A 5.26% (2/38), P58S 2.63% (1/39), and Y93H 21.05% (8/38). On NS5B were C316N 71.05% (27/38), C451H 2.63% (1/38), and I585C 2.63% (1/38). There was no significant correlation between the RASs (Y93H, V179I, Q80K, S122G, C316N) and HCV genotype (p > 0.05). The baseline serum HCV RNA and HCV cAg had a significant medium-degree correlation (r = 0.601, p = 0.002). After 1 week of DAA treatment was weak correlation (r = 0.413, p = 0.032). Q80K, S122G, V170I, Y93H, and C316N had no effect on the clearance of HCV RNA and HCV cAg within the first week of DAA treatment (p>0.05). Conclusion:The HCV genotype may have a limited impact on the presence of the five RASs (Y93H, V179I, Q80K, S122G, and C316N) as shown in this study. HCV RNA and HCV cAg have a correlation, especially at baseline is the highest; the appearance of some RASs has no effect on DAA treatment in most chronic hepatitis C patients.

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Threshold value of LIAISON XL anti‐HCV screening assay predicting positive immunoblotting results

Cited by 3 publications

References 33 publications

Using Treponemal Assay Signal Strength Cutoff Ratios To Predict Syphilis Infection

Using Treponemal Assay Signal Strength Cutoff Ratios To Predict Syphilis Infection

Evaluation of LIAISON® XL system for HBsAg, and anti‐HCV and anti‐HIV/Ag p24

Resistant-Associated Substitutions Do Not Affect HCV RNA and HCV Core Antigen Clearance During Direct-Acting Antiviral Agent Treatment in a Real-World Setting

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