Evaluation of portable point-of-care CD4 counter with high sensitivity for detecting patients eligible for antiretroviral therapy
Accurate, inexpensive point-of-care CD4+ T cell testing technologies are needed that can deliver CD4+ T cell results at lower level health centers or community outreach voluntary counseling and testing. We sought to evaluate a point-of-care CD4+ T cell counter, the Pima CD4 Test System, a portable,...
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| Veröffentlicht in: | PloS one 2012-04, Vol.7 (4), p.e34319-e34319 |
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| creator | Manabe, Yukari C Wang, Yaping Elbireer, Ali Auerbach, Brandon Castelnuovo, Barbara |
| description | Accurate, inexpensive point-of-care CD4+ T cell testing technologies are needed that can deliver CD4+ T cell results at lower level health centers or community outreach voluntary counseling and testing. We sought to evaluate a point-of-care CD4+ T cell counter, the Pima CD4 Test System, a portable, battery-operated bench-top instrument that is designed to use finger stick blood samples suitable for field use in conjunction with rapid HIV testing.
Duplicate measurements were performed on both capillary and venous samples using Pima CD4 analyzers, compared to the BD FACSCalibur (reference method). The mean bias was estimated by paired Student's t-test. Bland Altman plots were used to assess agreement.
206 participants were enrolled with a median CD4 count of 396 (range; 18-1500). The finger stick PIMA had a mean bias of -66.3 cells/µL (95%CI -83.4-49.2, P500 cells/µL) with a mean bias of -120.6 (95%CI -162.8, -78.4, P |
| doi_str_mv | 10.1371/journal.pone.0034319 |
| format | Article |
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Duplicate measurements were performed on both capillary and venous samples using Pima CD4 analyzers, compared to the BD FACSCalibur (reference method). The mean bias was estimated by paired Student's t-test. Bland Altman plots were used to assess agreement.
206 participants were enrolled with a median CD4 count of 396 (range; 18-1500). The finger stick PIMA had a mean bias of -66.3 cells/µL (95%CI -83.4-49.2, P<0.001) compared to the FACSCalibur; the bias was smaller at lower CD4 counts (0-250 cells/µL) with a mean bias of -10.8 (95%CI -27.3-+5.6, P = 0.198), and much greater at higher CD4 cell counts (>500 cells/µL) with a mean bias of -120.6 (95%CI -162.8, -78.4, P<0.001). The sensitivity (95%CI) of the Pima CD4 analyzer was 96.3% (79.1-99.8%) for a <250 cells/ul cut-off with a negative predictive value of 99.2% (95.1-99.9%).
The Pima CD4 finger stick test is an easy-to-use, portable, relatively fast device to test CD4+ T cell counts in the field. Issues of negatively-biased CD4 cell counts especially at higher absolute numbers will limit its utility for longitudinal immunologic response to ART. The high sensitivity and negative predictive value of the test makes it an attractive option for field use to identify patients eligible for ART, thus potentially reducing delays in linkage to care and ART initiation.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0034319</identifier><identifier>PMID: 22536323</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Acquired immune deficiency syndrome ; Adolescent ; Adult ; Aged ; AIDS ; Analyzers ; Anti-HIV Agents - therapeutic use ; Antiretroviral agents ; Antiretroviral drugs ; Antiretroviral therapy ; Batteries ; Bias ; Biology ; CD4 antigen ; CD4 Lymphocyte Count ; Clinics ; Comparative analysis ; Drug therapy ; Evaluation ; Female ; Field study ; Finger ; Fluorescent Antibody Technique, Direct ; Health facilities ; Health sciences ; Health services ; Highly active antiretroviral therapy ; HIV ; HIV Infections - drug therapy ; HIV Infections - immunology ; HIV tests ; Human immunodeficiency virus ; Humans ; Infectious diseases ; Instruments (Equipment) ; Laboratories ; Lymphocytes ; Lymphocytes T ; Male ; Measurement methods ; Medical diagnosis ; Medicine ; Middle Aged ; Mortality ; Pathology ; Patients ; Point-of-Care Systems ; Portable equipment ; Sensitivity ; Sensitivity analysis ; Sensitivity and Specificity ; T cells ; Test procedures ; Test systems ; Young Adult</subject><ispartof>PloS one, 2012-04, Vol.7 (4), p.e34319-e34319</ispartof><rights>COPYRIGHT 2012 Public Library of Science</rights><rights>2012 Manabe et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License: https://creativecommons.org/licenses/by/4.0/ (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><rights>Manabe et al. 2012</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-d49722298912b74d5afdf515f24a07b197e54e562eb410b08e01023111867ba03</citedby><cites>FETCH-LOGICAL-c692t-d49722298912b74d5afdf515f24a07b197e54e562eb410b08e01023111867ba03</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3334961/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3334961/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,2102,2928,23866,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/22536323$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Fox, Matthew P.</contributor><creatorcontrib>Manabe, Yukari C</creatorcontrib><creatorcontrib>Wang, Yaping</creatorcontrib><creatorcontrib>Elbireer, Ali</creatorcontrib><creatorcontrib>Auerbach, Brandon</creatorcontrib><creatorcontrib>Castelnuovo, Barbara</creatorcontrib><title>Evaluation of portable point-of-care CD4 counter with high sensitivity for detecting patients eligible for antiretroviral therapy</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>Accurate, inexpensive point-of-care CD4+ T cell testing technologies are needed that can deliver CD4+ T cell results at lower level health centers or community outreach voluntary counseling and testing. We sought to evaluate a point-of-care CD4+ T cell counter, the Pima CD4 Test System, a portable, battery-operated bench-top instrument that is designed to use finger stick blood samples suitable for field use in conjunction with rapid HIV testing.
Duplicate measurements were performed on both capillary and venous samples using Pima CD4 analyzers, compared to the BD FACSCalibur (reference method). The mean bias was estimated by paired Student's t-test. Bland Altman plots were used to assess agreement.
206 participants were enrolled with a median CD4 count of 396 (range; 18-1500). The finger stick PIMA had a mean bias of -66.3 cells/µL (95%CI -83.4-49.2, P<0.001) compared to the FACSCalibur; the bias was smaller at lower CD4 counts (0-250 cells/µL) with a mean bias of -10.8 (95%CI -27.3-+5.6, P = 0.198), and much greater at higher CD4 cell counts (>500 cells/µL) with a mean bias of -120.6 (95%CI -162.8, -78.4, P<0.001). The sensitivity (95%CI) of the Pima CD4 analyzer was 96.3% (79.1-99.8%) for a <250 cells/ul cut-off with a negative predictive value of 99.2% (95.1-99.9%).
The Pima CD4 finger stick test is an easy-to-use, portable, relatively fast device to test CD4+ T cell counts in the field. Issues of negatively-biased CD4 cell counts especially at higher absolute numbers will limit its utility for longitudinal immunologic response to ART. The high sensitivity and negative predictive value of the test makes it an attractive option for field use to identify patients eligible for ART, thus potentially reducing delays in linkage to care and ART initiation.</description><subject>Acquired immune deficiency syndrome</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>AIDS</subject><subject>Analyzers</subject><subject>Anti-HIV Agents - therapeutic use</subject><subject>Antiretroviral agents</subject><subject>Antiretroviral drugs</subject><subject>Antiretroviral therapy</subject><subject>Batteries</subject><subject>Bias</subject><subject>Biology</subject><subject>CD4 antigen</subject><subject>CD4 Lymphocyte Count</subject><subject>Clinics</subject><subject>Comparative analysis</subject><subject>Drug therapy</subject><subject>Evaluation</subject><subject>Female</subject><subject>Field study</subject><subject>Finger</subject><subject>Fluorescent Antibody Technique, Direct</subject><subject>Health facilities</subject><subject>Health sciences</subject><subject>Health services</subject><subject>Highly active antiretroviral therapy</subject><subject>HIV</subject><subject>HIV Infections - drug therapy</subject><subject>HIV Infections - immunology</subject><subject>HIV tests</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Infectious diseases</subject><subject>Instruments (Equipment)</subject><subject>Laboratories</subject><subject>Lymphocytes</subject><subject>Lymphocytes T</subject><subject>Male</subject><subject>Measurement methods</subject><subject>Medical diagnosis</subject><subject>Medicine</subject><subject>Middle Aged</subject><subject>Mortality</subject><subject>Pathology</subject><subject>Patients</subject><subject>Point-of-Care Systems</subject><subject>Portable equipment</subject><subject>Sensitivity</subject><subject>Sensitivity analysis</subject><subject>Sensitivity and Specificity</subject><subject>T cells</subject><subject>Test procedures</subject><subject>Test systems</subject><subject>Young Adult</subject><issn>1932-6203</issn><issn>1932-6203</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2012</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>DOA</sourceid><recordid>eNqNk12L1DAUhoso7rr6D0QLguhFx3y1aW6EZVx1YGHBr9uQtqdtlk5Tk3R0Lv3npjvdZSp7IblISJ7znpw3OVH0HKMVphy_uzaj7VW3GkwPK4Qoo1g8iE6xoCTJCKIPj9Yn0RPnrhFKaZ5lj6MTQlKaUUJPoz8XO9WNymvTx6aOB2O9KjoIC937xNRJqSzE6w8sLs3Ye7DxL-3buNVNGzvonfZ6p_0-ro2NK_BQet038RAEofcuhk43etKbzlXvtQVvzU5b1cW-BauG_dPoUa06B8_m-Sz6_vHi2_pzcnn1abM-v0zKTBCfVExwQojIBSYFZ1Wq6qpOcVoTphAvsOCQMkgzAgXDqEA5IIwIxRjnGS8UomfRy4Pu0BknZ_ecxJSwNBOCi0BsDkRl1LUcrN4qu5dGaXmzYWwjlfW67EAiXIiS8mB6zRkgIgpKM8xzIKLELJ-yvZ-zjcUWqjK4EWpeiC5Pet3KxuwkpZSJDAeBN7OANT9HcF5utSuh61QPZgz3vikvRYIF9NU_6P3VzVSjQgG6r03IW06i8pxxjrKM5jxQq3uoMCrY6jJ8tVqH_UXA20VAYDz89o0anZObr1_-n736sWRfH7EtqM63znTj9FPdEmQHsLTGOQv1nckYyalTbt2QU6fIuVNC2IvjB7oLum0N-hcZGQ3_</recordid><startdate>20120419</startdate><enddate>20120419</enddate><creator>Manabe, Yukari C</creator><creator>Wang, Yaping</creator><creator>Elbireer, Ali</creator><creator>Auerbach, Brandon</creator><creator>Castelnuovo, Barbara</creator><general>Public Library of Science</general><general>Public Library of Science (PLoS)</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>IOV</scope><scope>ISR</scope><scope>3V.</scope><scope>7QG</scope><scope>7QL</scope><scope>7QO</scope><scope>7RV</scope><scope>7SN</scope><scope>7SS</scope><scope>7T5</scope><scope>7TG</scope><scope>7TM</scope><scope>7U9</scope><scope>7X2</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FD</scope><scope>8FE</scope><scope>8FG</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABJCF</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>ARAPS</scope><scope>ATCPS</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BGLVJ</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>D1I</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB.</scope><scope>KB0</scope><scope>KL.</scope><scope>L6V</scope><scope>LK8</scope><scope>M0K</scope><scope>M0S</scope><scope>M1P</scope><scope>M7N</scope><scope>M7P</scope><scope>M7S</scope><scope>NAPCQ</scope><scope>P5Z</scope><scope>P62</scope><scope>P64</scope><scope>PATMY</scope><scope>PDBOC</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>PTHSS</scope><scope>PYCSY</scope><scope>RC3</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope></search><sort><creationdate>20120419</creationdate><title>Evaluation of portable point-of-care CD4 counter with high sensitivity for detecting patients eligible for antiretroviral therapy</title><author>Manabe, Yukari C ; Wang, Yaping ; Elbireer, Ali ; Auerbach, Brandon ; Castelnuovo, Barbara</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c692t-d49722298912b74d5afdf515f24a07b197e54e562eb410b08e01023111867ba03</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2012</creationdate><topic>Acquired immune deficiency syndrome</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>AIDS</topic><topic>Analyzers</topic><topic>Anti-HIV Agents - therapeutic use</topic><topic>Antiretroviral agents</topic><topic>Antiretroviral drugs</topic><topic>Antiretroviral therapy</topic><topic>Batteries</topic><topic>Bias</topic><topic>Biology</topic><topic>CD4 antigen</topic><topic>CD4 Lymphocyte Count</topic><topic>Clinics</topic><topic>Comparative analysis</topic><topic>Drug therapy</topic><topic>Evaluation</topic><topic>Female</topic><topic>Field study</topic><topic>Finger</topic><topic>Fluorescent Antibody Technique, Direct</topic><topic>Health facilities</topic><topic>Health sciences</topic><topic>Health services</topic><topic>Highly active antiretroviral therapy</topic><topic>HIV</topic><topic>HIV Infections - drug therapy</topic><topic>HIV Infections - immunology</topic><topic>HIV tests</topic><topic>Human immunodeficiency virus</topic><topic>Humans</topic><topic>Infectious diseases</topic><topic>Instruments (Equipment)</topic><topic>Laboratories</topic><topic>Lymphocytes</topic><topic>Lymphocytes T</topic><topic>Male</topic><topic>Measurement methods</topic><topic>Medical diagnosis</topic><topic>Medicine</topic><topic>Middle Aged</topic><topic>Mortality</topic><topic>Pathology</topic><topic>Patients</topic><topic>Point-of-Care Systems</topic><topic>Portable equipment</topic><topic>Sensitivity</topic><topic>Sensitivity analysis</topic><topic>Sensitivity and Specificity</topic><topic>T cells</topic><topic>Test procedures</topic><topic>Test systems</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Manabe, Yukari C</creatorcontrib><creatorcontrib>Wang, Yaping</creatorcontrib><creatorcontrib>Elbireer, Ali</creatorcontrib><creatorcontrib>Auerbach, Brandon</creatorcontrib><creatorcontrib>Castelnuovo, Barbara</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Gale In Context: Opposing Viewpoints</collection><collection>Gale In Context: Science</collection><collection>ProQuest Central (Corporate)</collection><collection>Animal Behavior Abstracts</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Biotechnology Research Abstracts</collection><collection>Nursing & Allied Health Database</collection><collection>Ecology Abstracts</collection><collection>Entomology Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>Meteorological & Geoastrophysical Abstracts</collection><collection>Nucleic Acids Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Agricultural Science Collection</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>Technology Research Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Technology Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Materials Science & Engineering Collection</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>Advanced Technologies & Aerospace Collection</collection><collection>Agricultural & Environmental Science Collection</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Technology Collection</collection><collection>Natural Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Materials Science Collection</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Materials Science Database</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Meteorological & Geoastrophysical Abstracts - 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Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Manabe, Yukari C</au><au>Wang, Yaping</au><au>Elbireer, Ali</au><au>Auerbach, Brandon</au><au>Castelnuovo, Barbara</au><au>Fox, Matthew P.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of portable point-of-care CD4 counter with high sensitivity for detecting patients eligible for antiretroviral therapy</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2012-04-19</date><risdate>2012</risdate><volume>7</volume><issue>4</issue><spage>e34319</spage><epage>e34319</epage><pages>e34319-e34319</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>Accurate, inexpensive point-of-care CD4+ T cell testing technologies are needed that can deliver CD4+ T cell results at lower level health centers or community outreach voluntary counseling and testing. We sought to evaluate a point-of-care CD4+ T cell counter, the Pima CD4 Test System, a portable, battery-operated bench-top instrument that is designed to use finger stick blood samples suitable for field use in conjunction with rapid HIV testing.
Duplicate measurements were performed on both capillary and venous samples using Pima CD4 analyzers, compared to the BD FACSCalibur (reference method). The mean bias was estimated by paired Student's t-test. Bland Altman plots were used to assess agreement.
206 participants were enrolled with a median CD4 count of 396 (range; 18-1500). The finger stick PIMA had a mean bias of -66.3 cells/µL (95%CI -83.4-49.2, P<0.001) compared to the FACSCalibur; the bias was smaller at lower CD4 counts (0-250 cells/µL) with a mean bias of -10.8 (95%CI -27.3-+5.6, P = 0.198), and much greater at higher CD4 cell counts (>500 cells/µL) with a mean bias of -120.6 (95%CI -162.8, -78.4, P<0.001). The sensitivity (95%CI) of the Pima CD4 analyzer was 96.3% (79.1-99.8%) for a <250 cells/ul cut-off with a negative predictive value of 99.2% (95.1-99.9%).
The Pima CD4 finger stick test is an easy-to-use, portable, relatively fast device to test CD4+ T cell counts in the field. Issues of negatively-biased CD4 cell counts especially at higher absolute numbers will limit its utility for longitudinal immunologic response to ART. The high sensitivity and negative predictive value of the test makes it an attractive option for field use to identify patients eligible for ART, thus potentially reducing delays in linkage to care and ART initiation.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>22536323</pmid><doi>10.1371/journal.pone.0034319</doi><tpages>e34319</tpages><oa>free_for_read</oa></addata></record> |
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| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2012-04, Vol.7 (4), p.e34319-e34319 |
| issn | 1932-6203 1932-6203 |
| language | eng |
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| source | MEDLINE; DOAJ Directory of Open Access Journals; Public Library of Science (PLoS) Journals Open Access; EZB-FREE-00999 freely available EZB journals; PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Acquired immune deficiency syndrome Adolescent Adult Aged AIDS Analyzers Anti-HIV Agents - therapeutic use Antiretroviral agents Antiretroviral drugs Antiretroviral therapy Batteries Bias Biology CD4 antigen CD4 Lymphocyte Count Clinics Comparative analysis Drug therapy Evaluation Female Field study Finger Fluorescent Antibody Technique, Direct Health facilities Health sciences Health services Highly active antiretroviral therapy HIV HIV Infections - drug therapy HIV Infections - immunology HIV tests Human immunodeficiency virus Humans Infectious diseases Instruments (Equipment) Laboratories Lymphocytes Lymphocytes T Male Measurement methods Medical diagnosis Medicine Middle Aged Mortality Pathology Patients Point-of-Care Systems Portable equipment Sensitivity Sensitivity analysis Sensitivity and Specificity T cells Test procedures Test systems Young Adult |
| title | Evaluation of portable point-of-care CD4 counter with high sensitivity for detecting patients eligible for antiretroviral therapy |
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