Point-of-care CD4 technology invalid result rates in public health care settings across five countries
Since 2010, point-of-care (POC) CD4 testing platforms have been introduced in both urban and rural settings to expand access to testing by bringing diagnostic services closer to patients. We conducted an analysis of routinely collected CD4 testing data to determine the invalid result rates associate...
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| Veröffentlicht in: | PloS one 2019-07, Vol.14 (7), p.e0219021-e0219021 |
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| creator | Lamp, Katherine McGovern, Seth Fong, Youyi Abere, Biruhtesfa Kebede, Adisu Ayana, Gonfa Mulugeta, Achamyeleh Atem, Chares Diko Elat Nfetam, Jean Bosco Nzuobontane, Divine Bollinger, Timothy Jani, Ilesh Sitoe, Nadia Kiyaga, Charles Senyama, George Mangwendeza, Phibeon Munyaradzi Mtapuri-Zinyowera, Sekesai Sacks, Jilian A Doi, Naoko Peter, Trevor F Vojnov, Lara |
| description | Since 2010, point-of-care (POC) CD4 testing platforms have been introduced in both urban and rural settings to expand access to testing by bringing diagnostic services closer to patients. We conducted an analysis of routinely collected CD4 testing data to determine the invalid result rates associated with POC CD4 testing.
We analyzed 981,152 CD4 testing records collected from Alere Pima Analyzers between January 2011 and December 2016 across five countries in sub-Saharan Africa. Routinely collected data and programmatic records were used to determine the rate of invalid test results per month, by facility type, and by operator based on cumulative usage during the study period. In addition, frequency of invalid test types and utilization of control beads were assessed.
Across the five countries, 75,530 invalid messages were returned, resulting in an overall invalid result rate of 7.7%. The invalid result rate by country ranged from 6.6% to 11.2%. Invalid result rates were consistent across facility types. Invalid result rates were inversely correlated with operator usage: low volume operators (500 tests over study period) experienced an invalid result rate of 5.5%. Two invalid result types (exposure position control and reagent control) accounted for nearly 50% of invalid results. Routine data showed that control beads were run on 88.3% of days that the device was used.
Our analysis found that the rate of invalid results was consistent across all types of health facilities, indicating that decentralization of POC CD4 testing to lower level health facilities did not exhibit high invalid result rates or increase cartridge wastage. Additionally, invalid result rates were inversely correlated to operator usage, with high-volume operators experiencing lower invalid result rates than low-volume operators. POC CD4 testing can, therefore, be performed in decentralized national testing programs; however, adequate training, quality assurance, routine monitoring, and ongoing mentorship should also be implemented for success. |
| doi_str_mv | 10.1371/journal.pone.0219021 |
| format | Article |
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We analyzed 981,152 CD4 testing records collected from Alere Pima Analyzers between January 2011 and December 2016 across five countries in sub-Saharan Africa. Routinely collected data and programmatic records were used to determine the rate of invalid test results per month, by facility type, and by operator based on cumulative usage during the study period. In addition, frequency of invalid test types and utilization of control beads were assessed.
Across the five countries, 75,530 invalid messages were returned, resulting in an overall invalid result rate of 7.7%. The invalid result rate by country ranged from 6.6% to 11.2%. Invalid result rates were consistent across facility types. Invalid result rates were inversely correlated with operator usage: low volume operators (<50 tests over study period) experienced an invalid result rate of 10.2%, while high volume operators (>500 tests over study period) experienced an invalid result rate of 5.5%. Two invalid result types (exposure position control and reagent control) accounted for nearly 50% of invalid results. Routine data showed that control beads were run on 88.3% of days that the device was used.
Our analysis found that the rate of invalid results was consistent across all types of health facilities, indicating that decentralization of POC CD4 testing to lower level health facilities did not exhibit high invalid result rates or increase cartridge wastage. Additionally, invalid result rates were inversely correlated to operator usage, with high-volume operators experiencing lower invalid result rates than low-volume operators. POC CD4 testing can, therefore, be performed in decentralized national testing programs; however, adequate training, quality assurance, routine monitoring, and ongoing mentorship should also be implemented for success.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0219021</identifier><identifier>PMID: 31276477</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Acquired immune deficiency syndrome ; Africa South of the Sahara ; AIDS ; Analyzers ; Beads ; Biology and Life Sciences ; Blood analyzers ; CD4 antigen ; CD4 Lymphocyte Count ; CD4 lymphocytes ; Computer and Information Sciences ; Cross-Sectional Studies ; Diagnostic systems ; Equipment and supplies ; Health aspects ; Health care facilities ; Health facilities ; HIV ; HIV Infections - immunology ; Human immunodeficiency virus ; Humans ; Laboratories ; Medicine and Health Sciences ; Mentoring ; Operators ; People and Places ; Point-of-Care Testing ; Public Health ; Quality assurance ; Quality management ; Reagents ; Reproducibility of Results ; Retrospective Studies ; Rural Health Services ; Statistics ; Systematic review ; Technology ; Test procedures ; Test validity ; Testing ; Wireless Technology - instrumentation</subject><ispartof>PloS one, 2019-07, Vol.14 (7), p.e0219021-e0219021</ispartof><rights>COPYRIGHT 2019 Public Library of Science</rights><rights>2019 Lamp et al. This is an open access article distributed under the terms of the Creative Commons Attribution License: http://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>2019 Lamp et al 2019 Lamp et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c692t-8ae2bc14c982596f9497bd823ca24cdbcec89c3e6f9856fcebe594759862dd673</citedby><cites>FETCH-LOGICAL-c692t-8ae2bc14c982596f9497bd823ca24cdbcec89c3e6f9856fcebe594759862dd673</cites><orcidid>0000-0003-0996-161X</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6611583/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC6611583/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2095,2914,23846,27903,27904,53770,53772,79347,79348</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/31276477$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Torpey, Kwasi</contributor><creatorcontrib>Lamp, Katherine</creatorcontrib><creatorcontrib>McGovern, Seth</creatorcontrib><creatorcontrib>Fong, Youyi</creatorcontrib><creatorcontrib>Abere, Biruhtesfa</creatorcontrib><creatorcontrib>Kebede, Adisu</creatorcontrib><creatorcontrib>Ayana, Gonfa</creatorcontrib><creatorcontrib>Mulugeta, Achamyeleh</creatorcontrib><creatorcontrib>Atem, Chares Diko</creatorcontrib><creatorcontrib>Elat Nfetam, Jean Bosco</creatorcontrib><creatorcontrib>Nzuobontane, Divine</creatorcontrib><creatorcontrib>Bollinger, Timothy</creatorcontrib><creatorcontrib>Jani, Ilesh</creatorcontrib><creatorcontrib>Sitoe, Nadia</creatorcontrib><creatorcontrib>Kiyaga, Charles</creatorcontrib><creatorcontrib>Senyama, George</creatorcontrib><creatorcontrib>Mangwendeza, Phibeon Munyaradzi</creatorcontrib><creatorcontrib>Mtapuri-Zinyowera, Sekesai</creatorcontrib><creatorcontrib>Sacks, Jilian A</creatorcontrib><creatorcontrib>Doi, Naoko</creatorcontrib><creatorcontrib>Peter, Trevor F</creatorcontrib><creatorcontrib>Vojnov, Lara</creatorcontrib><title>Point-of-care CD4 technology invalid result rates in public health care settings across five countries</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>Since 2010, point-of-care (POC) CD4 testing platforms have been introduced in both urban and rural settings to expand access to testing by bringing diagnostic services closer to patients. We conducted an analysis of routinely collected CD4 testing data to determine the invalid result rates associated with POC CD4 testing.
We analyzed 981,152 CD4 testing records collected from Alere Pima Analyzers between January 2011 and December 2016 across five countries in sub-Saharan Africa. Routinely collected data and programmatic records were used to determine the rate of invalid test results per month, by facility type, and by operator based on cumulative usage during the study period. In addition, frequency of invalid test types and utilization of control beads were assessed.
Across the five countries, 75,530 invalid messages were returned, resulting in an overall invalid result rate of 7.7%. The invalid result rate by country ranged from 6.6% to 11.2%. Invalid result rates were consistent across facility types. Invalid result rates were inversely correlated with operator usage: low volume operators (<50 tests over study period) experienced an invalid result rate of 10.2%, while high volume operators (>500 tests over study period) experienced an invalid result rate of 5.5%. Two invalid result types (exposure position control and reagent control) accounted for nearly 50% of invalid results. Routine data showed that control beads were run on 88.3% of days that the device was used.
Our analysis found that the rate of invalid results was consistent across all types of health facilities, indicating that decentralization of POC CD4 testing to lower level health facilities did not exhibit high invalid result rates or increase cartridge wastage. Additionally, invalid result rates were inversely correlated to operator usage, with high-volume operators experiencing lower invalid result rates than low-volume operators. POC CD4 testing can, therefore, be performed in decentralized national testing programs; however, adequate training, quality assurance, routine monitoring, and ongoing mentorship should also be implemented for success.</description><subject>Acquired immune deficiency syndrome</subject><subject>Africa South of the Sahara</subject><subject>AIDS</subject><subject>Analyzers</subject><subject>Beads</subject><subject>Biology and Life Sciences</subject><subject>Blood analyzers</subject><subject>CD4 antigen</subject><subject>CD4 Lymphocyte Count</subject><subject>CD4 lymphocytes</subject><subject>Computer and Information Sciences</subject><subject>Cross-Sectional Studies</subject><subject>Diagnostic systems</subject><subject>Equipment and supplies</subject><subject>Health aspects</subject><subject>Health care facilities</subject><subject>Health facilities</subject><subject>HIV</subject><subject>HIV Infections - immunology</subject><subject>Human immunodeficiency virus</subject><subject>Humans</subject><subject>Laboratories</subject><subject>Medicine and Health Sciences</subject><subject>Mentoring</subject><subject>Operators</subject><subject>People and Places</subject><subject>Point-of-Care Testing</subject><subject>Public Health</subject><subject>Quality assurance</subject><subject>Quality management</subject><subject>Reagents</subject><subject>Reproducibility of Results</subject><subject>Retrospective Studies</subject><subject>Rural Health Services</subject><subject>Statistics</subject><subject>Systematic review</subject><subject>Technology</subject><subject>Test procedures</subject><subject>Test validity</subject><subject>Testing</subject><subject>Wireless Technology - 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CD4 technology invalid result rates in public health care settings across five countries</title><author>Lamp, Katherine ; McGovern, Seth ; Fong, Youyi ; Abere, Biruhtesfa ; Kebede, Adisu ; Ayana, Gonfa ; Mulugeta, Achamyeleh ; Atem, Chares Diko ; Elat Nfetam, Jean Bosco ; Nzuobontane, Divine ; Bollinger, Timothy ; Jani, Ilesh ; Sitoe, Nadia ; Kiyaga, Charles ; Senyama, George ; Mangwendeza, Phibeon Munyaradzi ; Mtapuri-Zinyowera, Sekesai ; Sacks, Jilian A ; Doi, Naoko ; Peter, Trevor F ; Vojnov, Lara</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c692t-8ae2bc14c982596f9497bd823ca24cdbcec89c3e6f9856fcebe594759862dd673</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Acquired immune deficiency syndrome</topic><topic>Africa South of the Sahara</topic><topic>AIDS</topic><topic>Analyzers</topic><topic>Beads</topic><topic>Biology and Life Sciences</topic><topic>Blood 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one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Lamp, Katherine</au><au>McGovern, Seth</au><au>Fong, Youyi</au><au>Abere, Biruhtesfa</au><au>Kebede, Adisu</au><au>Ayana, Gonfa</au><au>Mulugeta, Achamyeleh</au><au>Atem, Chares Diko</au><au>Elat Nfetam, Jean Bosco</au><au>Nzuobontane, Divine</au><au>Bollinger, Timothy</au><au>Jani, Ilesh</au><au>Sitoe, Nadia</au><au>Kiyaga, Charles</au><au>Senyama, George</au><au>Mangwendeza, Phibeon Munyaradzi</au><au>Mtapuri-Zinyowera, Sekesai</au><au>Sacks, Jilian A</au><au>Doi, Naoko</au><au>Peter, Trevor F</au><au>Vojnov, Lara</au><au>Torpey, Kwasi</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Point-of-care CD4 technology invalid result rates in public health care settings across five countries</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2019-07-05</date><risdate>2019</risdate><volume>14</volume><issue>7</issue><spage>e0219021</spage><epage>e0219021</epage><pages>e0219021-e0219021</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>Since 2010, point-of-care (POC) CD4 testing platforms have been introduced in both urban and rural settings to expand access to testing by bringing diagnostic services closer to patients. We conducted an analysis of routinely collected CD4 testing data to determine the invalid result rates associated with POC CD4 testing.
We analyzed 981,152 CD4 testing records collected from Alere Pima Analyzers between January 2011 and December 2016 across five countries in sub-Saharan Africa. Routinely collected data and programmatic records were used to determine the rate of invalid test results per month, by facility type, and by operator based on cumulative usage during the study period. In addition, frequency of invalid test types and utilization of control beads were assessed.
Across the five countries, 75,530 invalid messages were returned, resulting in an overall invalid result rate of 7.7%. The invalid result rate by country ranged from 6.6% to 11.2%. Invalid result rates were consistent across facility types. Invalid result rates were inversely correlated with operator usage: low volume operators (<50 tests over study period) experienced an invalid result rate of 10.2%, while high volume operators (>500 tests over study period) experienced an invalid result rate of 5.5%. Two invalid result types (exposure position control and reagent control) accounted for nearly 50% of invalid results. Routine data showed that control beads were run on 88.3% of days that the device was used.
Our analysis found that the rate of invalid results was consistent across all types of health facilities, indicating that decentralization of POC CD4 testing to lower level health facilities did not exhibit high invalid result rates or increase cartridge wastage. Additionally, invalid result rates were inversely correlated to operator usage, with high-volume operators experiencing lower invalid result rates than low-volume operators. POC CD4 testing can, therefore, be performed in decentralized national testing programs; however, adequate training, quality assurance, routine monitoring, and ongoing mentorship should also be implemented for success.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>31276477</pmid><doi>10.1371/journal.pone.0219021</doi><tpages>e0219021</tpages><orcidid>https://orcid.org/0000-0003-0996-161X</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2019-07, Vol.14 (7), p.e0219021-e0219021 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_2252704425 |
| 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 Africa South of the Sahara AIDS Analyzers Beads Biology and Life Sciences Blood analyzers CD4 antigen CD4 Lymphocyte Count CD4 lymphocytes Computer and Information Sciences Cross-Sectional Studies Diagnostic systems Equipment and supplies Health aspects Health care facilities Health facilities HIV HIV Infections - immunology Human immunodeficiency virus Humans Laboratories Medicine and Health Sciences Mentoring Operators People and Places Point-of-Care Testing Public Health Quality assurance Quality management Reagents Reproducibility of Results Retrospective Studies Rural Health Services Statistics Systematic review Technology Test procedures Test validity Testing Wireless Technology - instrumentation |
| title | Point-of-care CD4 technology invalid result rates in public health care settings across five countries |
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