High-sensitive detection and quantitation of thyroid-stimulating hormone (TSH) from capillary/fingerstick and venepuncture whole-blood using fluorescence-based rapid lateral flow immunoassay (LFIA)
<h3>Background </h3><p dir="ltr">In the last decade, point of care testing (POCT) such as lateral flow immunoassays (LFIA) were developed for rapid TSH measurement. Most of these TSH-LFIAs are designed for qualitative measurements (i.e., if TSH values > 5, or >15 IU...
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2023
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| _version_ | 1864513507145285632 |
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| author | Samar Shurbaji (9938696) |
| author2 | Faleh Al Tamimi (19479850) Mahmoud M. Al Ghwairi (19479853) Dayana El Chaar (19479856) Salma Younes (6424865) Amin F. Majdalawieh (9225529) GianFranco Pintus (19479859) Nader Al-Dewik (4166527) Gheyath K. Nasrallah (9200525) |
| author2_role | author author author author author author author author |
| author_facet | Samar Shurbaji (9938696) Faleh Al Tamimi (19479850) Mahmoud M. Al Ghwairi (19479853) Dayana El Chaar (19479856) Salma Younes (6424865) Amin F. Majdalawieh (9225529) GianFranco Pintus (19479859) Nader Al-Dewik (4166527) Gheyath K. Nasrallah (9200525) |
| author_role | author |
| dc.creator.none.fl_str_mv | Samar Shurbaji (9938696) Faleh Al Tamimi (19479850) Mahmoud M. Al Ghwairi (19479853) Dayana El Chaar (19479856) Salma Younes (6424865) Amin F. Majdalawieh (9225529) GianFranco Pintus (19479859) Nader Al-Dewik (4166527) Gheyath K. Nasrallah (9200525) |
| dc.date.none.fl_str_mv | 2023-10-08T03:00:00Z |
| dc.identifier.none.fl_str_mv | 10.1016/j.heliyon.2023.e20589 |
| dc.relation.none.fl_str_mv | https://figshare.com/articles/journal_contribution/High-sensitive_detection_and_quantitation_of_thyroid-stimulating_hormone_TSH_from_capillary_fingerstick_and_venepuncture_whole-blood_using_fluorescence-based_rapid_lateral_flow_immunoassay_LFIA_/26827819 |
| dc.rights.none.fl_str_mv | CC BY 4.0 info:eu-repo/semantics/openAccess |
| dc.subject.none.fl_str_mv | Biomedical and clinical sciences Clinical sciences Medical biochemistry and metabolomics TSH Evaluation LIFA rapid test Finecare Roche |
| dc.title.none.fl_str_mv | High-sensitive detection and quantitation of thyroid-stimulating hormone (TSH) from capillary/fingerstick and venepuncture whole-blood using fluorescence-based rapid lateral flow immunoassay (LFIA) |
| dc.type.none.fl_str_mv | Text Journal contribution info:eu-repo/semantics/publishedVersion text contribution to journal |
| description | <h3>Background </h3><p dir="ltr">In the last decade, point of care testing (POCT) such as lateral flow immunoassays (LFIA) were developed for rapid TSH measurement. Most of these TSH-LFIAs are designed for qualitative measurements (i.e., if TSH values > 5, or >15 IU/L) and as screening tests for primary hypothyroidism in children and adults. Serum or plasma, but not venepuncture whole-blood or fingerstick/capillary, are usually used to quantify TSH accurately. Studies on performance evaluation of TSH-LFIAs POCT using venepuncture or fingerstick whole-blood are limited. Additionally, limited studies evaluated the performance and validity of TSH-LFIAs POCT compared to valid and reliable reference methods. To our knowledge, this is the first study to evaluate three different blood withdrawal techniques for evaluating POCT of TSH. </p><h3>Aim </h3><p dir="ltr">We aim to evaluate the performance of a new fluorescence-based LFIA and its Finecare™ fluorescent reader for quantitative measurement of TSH from a fingerstick, venepuncture whole-blood, and serum. </p><h3>Methods </h3><p dir="ltr">102 fingerstick, venepuncture whole-blood, and serum samples (with normal and abnormal TSH values) were analyzed by Finecare™ Rapid Quantitative LFIA test and Roche cobas® e 601 as a reference test. </p><h3>Results </h3><p dir="ltr">Using serum, when compared to cobas® e 601 reference method, Finecare™ showed high sensitivity [90.5 % (69.6–98.8)] and specificity [96.3 % (89.6–99.2)] for diagnosis of thyroid abnormalities (<0.35 or >4.5 mIU/L). The actual test values (mIU/L) of Finecare™ showed excellent agreement (Cohen's Kappa = 0.85) and strong correlation (r = 0.93, p < 0.0001) with cobas® e 601. Using venepuncture whole-blood samples, Finecare™ showed similar results to serum with high sensitivity [95.2 % (76.2–99.9)], specificity [97.5 % (91.4–99.7)], excellent agreement (Cohen's Kappa = 0.91), and very strong correlation (r = 0.95, p < 0.0001) with cobas® e 601. These results suggest that Finecare™ can be used for quantitative measurement of TSH using serum or venepuncture whole-blood. These key performance indicators were slightly decreased when fingerstick whole-blood samples were used: sensitivity [85.7 %(63.7–97)], specificity [90.0 %,(81.5–96)], good agreement (Cohen's Kappa = 0.7) and very strong correlation (r = 0.9, p < 0.0001) with cobas® e 601. A subgroup analysis of abnormal TSH samples revealed a strong and significant correlation between the reference, Finecare™ whole-blood (r = 0.692; p = 0.0015), and fingerstick test Finecare™ (r = 0.66; p = 0.0025). A very strong correlation was also observed between cobas® e 601 serum and Finecare™ serum (r = 0.88; p < 0.0001). Conclusion: In comparison to the reference assay, our study demonstrates that Finecare™ exhibits high sensitivity, specificity, agreement, and a strong correlation. These findings provide evidence that Finecare™ is a reliable, valid, and accurate point-of-care test for TSH screening and quantitative measurement, especially in non- or small laboratory settings.</p><h2>Other Information</h2><p dir="ltr">Published in: Heliyon<br>License: <a href="http://creativecommons.org/licenses/by/4.0/" target="_blank">http://creativecommons.org/licenses/by/4.0/</a><br>See article on publisher's website: <a href="https://dx.doi.org/10.1016/j.heliyon.2023.e20589" target="_blank">https://dx.doi.org/10.1016/j.heliyon.2023.e20589</a></p> |
| eu_rights_str_mv | openAccess |
| id | Manara2_1605f1756f26eea1efbf26ad0fa27882 |
| identifier_str_mv | 10.1016/j.heliyon.2023.e20589 |
| network_acronym_str | Manara2 |
| network_name_str | Manara2 |
| oai_identifier_str | oai:figshare.com:article/26827819 |
| publishDate | 2023 |
| repository.mail.fl_str_mv | |
| repository.name.fl_str_mv | |
| repository_id_str | |
| rights_invalid_str_mv | CC BY 4.0 |
| spelling | High-sensitive detection and quantitation of thyroid-stimulating hormone (TSH) from capillary/fingerstick and venepuncture whole-blood using fluorescence-based rapid lateral flow immunoassay (LFIA)Samar Shurbaji (9938696)Faleh Al Tamimi (19479850)Mahmoud M. Al Ghwairi (19479853)Dayana El Chaar (19479856)Salma Younes (6424865)Amin F. Majdalawieh (9225529)GianFranco Pintus (19479859)Nader Al-Dewik (4166527)Gheyath K. Nasrallah (9200525)Biomedical and clinical sciencesClinical sciencesMedical biochemistry and metabolomicsTSHEvaluationLIFA rapid testFinecareRoche<h3>Background </h3><p dir="ltr">In the last decade, point of care testing (POCT) such as lateral flow immunoassays (LFIA) were developed for rapid TSH measurement. Most of these TSH-LFIAs are designed for qualitative measurements (i.e., if TSH values > 5, or >15 IU/L) and as screening tests for primary hypothyroidism in children and adults. Serum or plasma, but not venepuncture whole-blood or fingerstick/capillary, are usually used to quantify TSH accurately. Studies on performance evaluation of TSH-LFIAs POCT using venepuncture or fingerstick whole-blood are limited. Additionally, limited studies evaluated the performance and validity of TSH-LFIAs POCT compared to valid and reliable reference methods. To our knowledge, this is the first study to evaluate three different blood withdrawal techniques for evaluating POCT of TSH. </p><h3>Aim </h3><p dir="ltr">We aim to evaluate the performance of a new fluorescence-based LFIA and its Finecare™ fluorescent reader for quantitative measurement of TSH from a fingerstick, venepuncture whole-blood, and serum. </p><h3>Methods </h3><p dir="ltr">102 fingerstick, venepuncture whole-blood, and serum samples (with normal and abnormal TSH values) were analyzed by Finecare™ Rapid Quantitative LFIA test and Roche cobas® e 601 as a reference test. </p><h3>Results </h3><p dir="ltr">Using serum, when compared to cobas® e 601 reference method, Finecare™ showed high sensitivity [90.5 % (69.6–98.8)] and specificity [96.3 % (89.6–99.2)] for diagnosis of thyroid abnormalities (<0.35 or >4.5 mIU/L). The actual test values (mIU/L) of Finecare™ showed excellent agreement (Cohen's Kappa = 0.85) and strong correlation (r = 0.93, p < 0.0001) with cobas® e 601. Using venepuncture whole-blood samples, Finecare™ showed similar results to serum with high sensitivity [95.2 % (76.2–99.9)], specificity [97.5 % (91.4–99.7)], excellent agreement (Cohen's Kappa = 0.91), and very strong correlation (r = 0.95, p < 0.0001) with cobas® e 601. These results suggest that Finecare™ can be used for quantitative measurement of TSH using serum or venepuncture whole-blood. These key performance indicators were slightly decreased when fingerstick whole-blood samples were used: sensitivity [85.7 %(63.7–97)], specificity [90.0 %,(81.5–96)], good agreement (Cohen's Kappa = 0.7) and very strong correlation (r = 0.9, p < 0.0001) with cobas® e 601. A subgroup analysis of abnormal TSH samples revealed a strong and significant correlation between the reference, Finecare™ whole-blood (r = 0.692; p = 0.0015), and fingerstick test Finecare™ (r = 0.66; p = 0.0025). A very strong correlation was also observed between cobas® e 601 serum and Finecare™ serum (r = 0.88; p < 0.0001). Conclusion: In comparison to the reference assay, our study demonstrates that Finecare™ exhibits high sensitivity, specificity, agreement, and a strong correlation. These findings provide evidence that Finecare™ is a reliable, valid, and accurate point-of-care test for TSH screening and quantitative measurement, especially in non- or small laboratory settings.</p><h2>Other Information</h2><p dir="ltr">Published in: Heliyon<br>License: <a href="http://creativecommons.org/licenses/by/4.0/" target="_blank">http://creativecommons.org/licenses/by/4.0/</a><br>See article on publisher's website: <a href="https://dx.doi.org/10.1016/j.heliyon.2023.e20589" target="_blank">https://dx.doi.org/10.1016/j.heliyon.2023.e20589</a></p>2023-10-08T03:00:00ZTextJournal contributioninfo:eu-repo/semantics/publishedVersiontextcontribution to journal10.1016/j.heliyon.2023.e20589https://figshare.com/articles/journal_contribution/High-sensitive_detection_and_quantitation_of_thyroid-stimulating_hormone_TSH_from_capillary_fingerstick_and_venepuncture_whole-blood_using_fluorescence-based_rapid_lateral_flow_immunoassay_LFIA_/26827819CC BY 4.0info:eu-repo/semantics/openAccessoai:figshare.com:article/268278192023-10-08T03:00:00Z |
| spellingShingle | High-sensitive detection and quantitation of thyroid-stimulating hormone (TSH) from capillary/fingerstick and venepuncture whole-blood using fluorescence-based rapid lateral flow immunoassay (LFIA) Samar Shurbaji (9938696) Biomedical and clinical sciences Clinical sciences Medical biochemistry and metabolomics TSH Evaluation LIFA rapid test Finecare Roche |
| status_str | publishedVersion |
| title | High-sensitive detection and quantitation of thyroid-stimulating hormone (TSH) from capillary/fingerstick and venepuncture whole-blood using fluorescence-based rapid lateral flow immunoassay (LFIA) |
| title_full | High-sensitive detection and quantitation of thyroid-stimulating hormone (TSH) from capillary/fingerstick and venepuncture whole-blood using fluorescence-based rapid lateral flow immunoassay (LFIA) |
| title_fullStr | High-sensitive detection and quantitation of thyroid-stimulating hormone (TSH) from capillary/fingerstick and venepuncture whole-blood using fluorescence-based rapid lateral flow immunoassay (LFIA) |
| title_full_unstemmed | High-sensitive detection and quantitation of thyroid-stimulating hormone (TSH) from capillary/fingerstick and venepuncture whole-blood using fluorescence-based rapid lateral flow immunoassay (LFIA) |
| title_short | High-sensitive detection and quantitation of thyroid-stimulating hormone (TSH) from capillary/fingerstick and venepuncture whole-blood using fluorescence-based rapid lateral flow immunoassay (LFIA) |
| title_sort | High-sensitive detection and quantitation of thyroid-stimulating hormone (TSH) from capillary/fingerstick and venepuncture whole-blood using fluorescence-based rapid lateral flow immunoassay (LFIA) |
| topic | Biomedical and clinical sciences Clinical sciences Medical biochemistry and metabolomics TSH Evaluation LIFA rapid test Finecare Roche |