Performance Evaluation of BD FACSPresto<sup>TM</sup> Near-Patient CD4 Counter for Monitoring Antiretroviral Therapy in HIV-Infected Individuals in Primary Healthcare Clinics in Thailand
HIV viral load is more reliable tool for monitoring treatment throughout the course of HIV/AIDS, but the test may be expensive in resource-limited settings. Therefore, enumeration of CD4 T-lymphocyte count remains important in these settings. This study evaluated the performance of BDFACSPresto, a n...
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| Format: | Article |
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MDPI AG
2022-02-01
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| Series: | Diagnostics |
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| Online Access: | https://www.mdpi.com/2075-4418/12/2/382 |
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| author | Kasama Sukapirom Somrat Matchua Charin Thepthai Narinee Srimark Ladawan Khowawisetsut Kovit Pattanapanyasat |
| author_facet | Kasama Sukapirom Somrat Matchua Charin Thepthai Narinee Srimark Ladawan Khowawisetsut Kovit Pattanapanyasat |
| author_sort | Kasama Sukapirom |
| collection | DOAJ |
| description | HIV viral load is more reliable tool for monitoring treatment throughout the course of HIV/AIDS, but the test may be expensive in resource-limited settings. Therefore, enumeration of CD4 T-lymphocyte count remains important in these settings. This study evaluated the performance of BDFACSPresto, a near-patient CD4 counter planned to be used in primary healthcare clinics in Thailand. Results of percent, absolute CD4 count and hemoglobin (Hb) on the FACSPresto were compared with the TriTEST/TruCOUNT/BDFACSCalibur method and a Sysmex hematology analyzer. Phase I of the study was performed in an ISO15189 laboratory. Both percentage and absolute values showed Passing–Bablok slopes within 0.98–1.06 and 0.97–1.13, mean Bland–Altman biases of +1.2% and +20.5 cells/µL, respectively. In phase II, venous and some capillary blood samples were analyzed in four primary healthcare clinics. The results showed good correlation between capillary and venous blood. For venous blood samples, regression lines showed slopes of 1.01–1.05 and 1.01–1.07 for all percentage and absolute values. The overall mean biases were +0.9% and +17.0 cells/µL. For Hb, Passing–Bablok regression result gave slope within 1.01–1.07 and mean bias of −0.06 g/dL. Thus, CD4 enumeration in blood by the FACSPresto is reliable and can be performed to an identical standard at primary healthcare clinics. |
| first_indexed | 2024-03-09T22:11:01Z |
| format | Article |
| id | doaj.art-0eb62a7b0dd34a4e9388c675d2001bcd |
| institution | Directory Open Access Journal |
| issn | 2075-4418 |
| language | English |
| last_indexed | 2024-03-09T22:11:01Z |
| publishDate | 2022-02-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Diagnostics |
| spelling | doaj.art-0eb62a7b0dd34a4e9388c675d2001bcd2023-11-23T19:31:08ZengMDPI AGDiagnostics2075-44182022-02-0112238210.3390/diagnostics12020382Performance Evaluation of BD FACSPresto<sup>TM</sup> Near-Patient CD4 Counter for Monitoring Antiretroviral Therapy in HIV-Infected Individuals in Primary Healthcare Clinics in ThailandKasama Sukapirom0Somrat Matchua1Charin Thepthai2Narinee Srimark3Ladawan Khowawisetsut4Kovit Pattanapanyasat5Siriraj Center of Research Excellence in Microparticle and Exosome in Diseases, Research Department, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, ThailandDepartment of Medical Technology, Chonburi Hospital, Chonburi 20000, ThailandDepartment of Immunology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, ThailandSiriraj Center of Research Excellence in Microparticle and Exosome in Diseases, Research Department, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, ThailandDepartment of Parasitology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, ThailandSiriraj Center of Research Excellence in Microparticle and Exosome in Diseases, Research Department, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok 10700, ThailandHIV viral load is more reliable tool for monitoring treatment throughout the course of HIV/AIDS, but the test may be expensive in resource-limited settings. Therefore, enumeration of CD4 T-lymphocyte count remains important in these settings. This study evaluated the performance of BDFACSPresto, a near-patient CD4 counter planned to be used in primary healthcare clinics in Thailand. Results of percent, absolute CD4 count and hemoglobin (Hb) on the FACSPresto were compared with the TriTEST/TruCOUNT/BDFACSCalibur method and a Sysmex hematology analyzer. Phase I of the study was performed in an ISO15189 laboratory. Both percentage and absolute values showed Passing–Bablok slopes within 0.98–1.06 and 0.97–1.13, mean Bland–Altman biases of +1.2% and +20.5 cells/µL, respectively. In phase II, venous and some capillary blood samples were analyzed in four primary healthcare clinics. The results showed good correlation between capillary and venous blood. For venous blood samples, regression lines showed slopes of 1.01–1.05 and 1.01–1.07 for all percentage and absolute values. The overall mean biases were +0.9% and +17.0 cells/µL. For Hb, Passing–Bablok regression result gave slope within 1.01–1.07 and mean bias of −0.06 g/dL. Thus, CD4 enumeration in blood by the FACSPresto is reliable and can be performed to an identical standard at primary healthcare clinics.https://www.mdpi.com/2075-4418/12/2/382AIDSCD4FACSPrestoflow cytometryHIVpoint-of-care testing |
| spellingShingle | Kasama Sukapirom Somrat Matchua Charin Thepthai Narinee Srimark Ladawan Khowawisetsut Kovit Pattanapanyasat Performance Evaluation of BD FACSPresto<sup>TM</sup> Near-Patient CD4 Counter for Monitoring Antiretroviral Therapy in HIV-Infected Individuals in Primary Healthcare Clinics in Thailand Diagnostics AIDS CD4 FACSPresto flow cytometry HIV point-of-care testing |
| title | Performance Evaluation of BD FACSPresto<sup>TM</sup> Near-Patient CD4 Counter for Monitoring Antiretroviral Therapy in HIV-Infected Individuals in Primary Healthcare Clinics in Thailand |
| title_full | Performance Evaluation of BD FACSPresto<sup>TM</sup> Near-Patient CD4 Counter for Monitoring Antiretroviral Therapy in HIV-Infected Individuals in Primary Healthcare Clinics in Thailand |
| title_fullStr | Performance Evaluation of BD FACSPresto<sup>TM</sup> Near-Patient CD4 Counter for Monitoring Antiretroviral Therapy in HIV-Infected Individuals in Primary Healthcare Clinics in Thailand |
| title_full_unstemmed | Performance Evaluation of BD FACSPresto<sup>TM</sup> Near-Patient CD4 Counter for Monitoring Antiretroviral Therapy in HIV-Infected Individuals in Primary Healthcare Clinics in Thailand |
| title_short | Performance Evaluation of BD FACSPresto<sup>TM</sup> Near-Patient CD4 Counter for Monitoring Antiretroviral Therapy in HIV-Infected Individuals in Primary Healthcare Clinics in Thailand |
| title_sort | performance evaluation of bd facspresto sup tm sup near patient cd4 counter for monitoring antiretroviral therapy in hiv infected individuals in primary healthcare clinics in thailand |
| topic | AIDS CD4 FACSPresto flow cytometry HIV point-of-care testing |
| url | https://www.mdpi.com/2075-4418/12/2/382 |
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