A new double-antigen sandwich test based on the light-initiated chemiluminescent assay for detecting anti-hepatitis C virus antibodies with high sensitivity and specificity
ObjectivesThe aim of this study was to evaluate the performance of a new double-antigen sandwich test that is based on the light-initiated chemiluminescent assay (LiCA®) for detecting anti-hepatitis C virus antibodies (anti-HCV) in comparison to Architect®.MethodsAnalytical characteristics and diagn...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2023-11-01
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| Series: | Frontiers in Cellular and Infection Microbiology |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fcimb.2023.1222778/full |
| _version_ | 1797464833822556160 |
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| author | Haicong Li Shuo Yang Dan Cao Qianying Wang Siyu Zhang Yi Zhou Di Liu Ruifeng Yang Liyan Cui Zhaoqin Zhu |
| author_facet | Haicong Li Shuo Yang Dan Cao Qianying Wang Siyu Zhang Yi Zhou Di Liu Ruifeng Yang Liyan Cui Zhaoqin Zhu |
| author_sort | Haicong Li |
| collection | DOAJ |
| description | ObjectivesThe aim of this study was to evaluate the performance of a new double-antigen sandwich test that is based on the light-initiated chemiluminescent assay (LiCA®) for detecting anti-hepatitis C virus antibodies (anti-HCV) in comparison to Architect®.MethodsAnalytical characteristics and diagnostic performance were tested using seroconversion panels and large pools of clinical samples. Positive results were validated by the strip immunoblot assay (RIBA) and HCV RNA.ResultsRepeatability and within-lab imprecision of LiCA® anti-HCV were 1.31%–3.27%. The C5–C95 interval was −5.44%–5.03% away from C50. LiCA® detected seroconversion in an average of 28.9 days and showed a mean of 3.7 (p = 0.0056) days earlier than Architect®. In a pool of 239 samples with known HCV genotypes 1 to 6, both assays correctly detected all subjects. In 16,305 clinical patient sera, LiCA® detected 4 false-negative (0.25‰) and 14 false-positive (0.86‰) anti-HCV cases, while Architect® recorded 6 false-negative (0.37‰) and 138 false-positive (8.46‰) subjects, respectively. Compared to Architect®, LiCA® presented a significantly better performance in specificity (99.91% vs. 99.14%, n = 16,018, p < 0.0001), positive predictive value (95.29% vs. 67.06%, n = 419, p < 0.0001), and overall accuracy (99.89% vs. 99.12%, n = 16,305, p < 0.0001), while no significant difference in sensitivity (98.61% vs. 97.91%, n = 287, p = 0.5217) and negative predictive value (99.98% vs. 99.96%, n = 15,886, p = 0.3021) was seen. An S/Co value of 3.28 was predicted to be the threshold with a positivity ≥95% for the LiCA® anti-HCV assay.ConclusionLiCA® anti-HCV is a precise and fully automatic chemiluminescent assay with superior sensitivity and specificity. The assay can be used as a valuable tool to supplement the diagnosis of HCV infection. |
| first_indexed | 2024-03-09T18:13:47Z |
| format | Article |
| id | doaj.art-63021c54e0204159b083a130ea528c42 |
| institution | Directory Open Access Journal |
| issn | 2235-2988 |
| language | English |
| last_indexed | 2024-03-09T18:13:47Z |
| publishDate | 2023-11-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Cellular and Infection Microbiology |
| spelling | doaj.art-63021c54e0204159b083a130ea528c422023-11-24T08:54:56ZengFrontiers Media S.A.Frontiers in Cellular and Infection Microbiology2235-29882023-11-011310.3389/fcimb.2023.12227781222778A new double-antigen sandwich test based on the light-initiated chemiluminescent assay for detecting anti-hepatitis C virus antibodies with high sensitivity and specificityHaicong Li0Shuo Yang1Dan Cao2Qianying Wang3Siyu Zhang4Yi Zhou5Di Liu6Ruifeng Yang7Liyan Cui8Zhaoqin Zhu9Department of Laboratory Medicine, Shanghai Public Health Clinical Center, Shanghai, ChinaDepartment of Laboratory Medicine, Peking University Third Hospital, Beijing, ChinaDepartment of Laboratory Medicine, Shanghai Public Health Clinical Center, Shanghai, ChinaDepartment of Laboratory Medicine, Shanghai Public Health Clinical Center, Shanghai, ChinaDepartment of Laboratory Medicine, Peking University Third Hospital, Beijing, ChinaDepartment of Laboratory Medicine, Shanghai Public Health Clinical Center, Shanghai, ChinaDepartment of Laboratory Medicine, Peking University Third Hospital, Beijing, ChinaPeking University People’s Hospital, Peking University Hepatology Institute, Beijing, ChinaDepartment of Laboratory Medicine, Peking University Third Hospital, Beijing, ChinaDepartment of Laboratory Medicine, Shanghai Public Health Clinical Center, Shanghai, ChinaObjectivesThe aim of this study was to evaluate the performance of a new double-antigen sandwich test that is based on the light-initiated chemiluminescent assay (LiCA®) for detecting anti-hepatitis C virus antibodies (anti-HCV) in comparison to Architect®.MethodsAnalytical characteristics and diagnostic performance were tested using seroconversion panels and large pools of clinical samples. Positive results were validated by the strip immunoblot assay (RIBA) and HCV RNA.ResultsRepeatability and within-lab imprecision of LiCA® anti-HCV were 1.31%–3.27%. The C5–C95 interval was −5.44%–5.03% away from C50. LiCA® detected seroconversion in an average of 28.9 days and showed a mean of 3.7 (p = 0.0056) days earlier than Architect®. In a pool of 239 samples with known HCV genotypes 1 to 6, both assays correctly detected all subjects. In 16,305 clinical patient sera, LiCA® detected 4 false-negative (0.25‰) and 14 false-positive (0.86‰) anti-HCV cases, while Architect® recorded 6 false-negative (0.37‰) and 138 false-positive (8.46‰) subjects, respectively. Compared to Architect®, LiCA® presented a significantly better performance in specificity (99.91% vs. 99.14%, n = 16,018, p < 0.0001), positive predictive value (95.29% vs. 67.06%, n = 419, p < 0.0001), and overall accuracy (99.89% vs. 99.12%, n = 16,305, p < 0.0001), while no significant difference in sensitivity (98.61% vs. 97.91%, n = 287, p = 0.5217) and negative predictive value (99.98% vs. 99.96%, n = 15,886, p = 0.3021) was seen. An S/Co value of 3.28 was predicted to be the threshold with a positivity ≥95% for the LiCA® anti-HCV assay.ConclusionLiCA® anti-HCV is a precise and fully automatic chemiluminescent assay with superior sensitivity and specificity. The assay can be used as a valuable tool to supplement the diagnosis of HCV infection.https://www.frontiersin.org/articles/10.3389/fcimb.2023.1222778/fullhepatitis C virusLiCA® anti-HCVArchitect® anti-HCVdouble-antigen sandwichperformance evaluation |
| spellingShingle | Haicong Li Shuo Yang Dan Cao Qianying Wang Siyu Zhang Yi Zhou Di Liu Ruifeng Yang Liyan Cui Zhaoqin Zhu A new double-antigen sandwich test based on the light-initiated chemiluminescent assay for detecting anti-hepatitis C virus antibodies with high sensitivity and specificity Frontiers in Cellular and Infection Microbiology hepatitis C virus LiCA® anti-HCV Architect® anti-HCV double-antigen sandwich performance evaluation |
| title | A new double-antigen sandwich test based on the light-initiated chemiluminescent assay for detecting anti-hepatitis C virus antibodies with high sensitivity and specificity |
| title_full | A new double-antigen sandwich test based on the light-initiated chemiluminescent assay for detecting anti-hepatitis C virus antibodies with high sensitivity and specificity |
| title_fullStr | A new double-antigen sandwich test based on the light-initiated chemiluminescent assay for detecting anti-hepatitis C virus antibodies with high sensitivity and specificity |
| title_full_unstemmed | A new double-antigen sandwich test based on the light-initiated chemiluminescent assay for detecting anti-hepatitis C virus antibodies with high sensitivity and specificity |
| title_short | A new double-antigen sandwich test based on the light-initiated chemiluminescent assay for detecting anti-hepatitis C virus antibodies with high sensitivity and specificity |
| title_sort | new double antigen sandwich test based on the light initiated chemiluminescent assay for detecting anti hepatitis c virus antibodies with high sensitivity and specificity |
| topic | hepatitis C virus LiCA® anti-HCV Architect® anti-HCV double-antigen sandwich performance evaluation |
| url | https://www.frontiersin.org/articles/10.3389/fcimb.2023.1222778/full |
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