Development and validation of point‐of‐care testing of albuminuria for early screening of chronic kidney disease
Introduction Chronic kidney disease (CKD) is a significant global health issue. As the prevalence of renal replacement therapy (RRT) in Thailand is increasing, early detection and management of CKD is the most important step to prevent CKD progression and the need for RRT. Current diagnostic tests f...
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| Veröffentlicht in: | Journal of clinical laboratory analysis 2021-04, Vol.35 (4), p.e23729-n/a |
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| creator | Vutthikraivit, Nuntanuj Kiatamornrak, Patcharakorn Boonkrai, Chatikorn Pisitkun, Trairak Komolpis, Kittinan Puthong, Songchan Lumlertgul, Nuttha Peerapornratana, Sadudee Thanawattano, Chusak Tungsanga, Somkanya Praditpornsilpa, Kearkiat Tungsanga, Kriang Eiam‐Ong, Somchai Srisawat, Nattachai |
| description | Introduction
Chronic kidney disease (CKD) is a significant global health issue. As the prevalence of renal replacement therapy (RRT) in Thailand is increasing, early detection and management of CKD is the most important step to prevent CKD progression and the need for RRT. Current diagnostic tests for CKD are non‐specific and expensive. We aimed to develop and validate antibody‐based‐albumin point‐of‐care testing (POCT) to detect patients with impaired kidney function at early stage.
Methods
The prototype strip test was developed under the concept of competitive lateral flow immunochromatography assay, or strip test. Monoclonal antibodies (MAbs) to human serum albumin (HSA) were harvested from the hybridomas of spleen cells from immunized mice and mouse myeloma cells. Presence of MAbs was detected by enzyme‐linked immunosorbent assay (ELISA). Spot urine was obtained from patients with kidney disease, type I, or type II Diabetes Mellitus upon their visit at King Chulalongkorn Memorial Hospital during 2018–2019. All samples were analyzed for urine albumin with our POCT (CU microalbumin) and the other two commercial POCTs (Microalbu PHAN and MICRAL). The results were validated against standard method for urine microalbumin measurement. A urine microalbumin concentration of less than 20 ug/ml was defined as normal. The sensitivity, specificity, and predictive values were calculated in comparison with the standard laboratory method.
Result
A total of 100 adult patients were included. CU microalbumin had a sensitivity of 86%, a specificity of 94%, and a positive predictive value of 96%. Our POCT showed good correlation with the laboratory results.
Conclusion
CU microalbumin correlated well with the standard method for quantitative measurement of urine albumin. Therefore, it has the potential for early screening of CKD, especially in primary health care facilities in resource limited settings. |
| doi_str_mv | 10.1002/jcla.23729 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_8059747</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2515755065</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4489-7836578f111558adf2eb5ca8b7bec432c4159dfe24b8346d540b40623aec8a623</originalsourceid><addsrcrecordid>eNp9kcuKFDEUhoMoTju68QEk4GYQasy1KtkIQ3unwY2uQyp1aiZtOmmTqpbe-Qg-o09i2m4HdeHmnMX5-Dg_P0KPKbmkhLDnaxfsJeMd03fQghKtGqaYvIsWRKmuUYTyM_SglDUhRGna3kdnnEtNtKALNL2EHYS03UCcsI0D3tngBzv5FHEa8Tb5OP349j2NdTibAU9QJh-vD0cb-nnj45y9xWPKGGwOe1xcBognxN3kFL3Dn_0QYY8HX8AWeIjujTYUeHTa5-jT61cfl2-b1Yc375ZXq8YJoXTTKd7KTo2UUimVHUYGvXRW9V0PTnDmBJV6GIGJXnHRDlKQXpCWcQtO2brP0Yujdzv3GxhczZhtMNvsNzbvTbLe_H2J_sZcp51RROpOdFVwcRLk9GWuyc3GFwch2AhpLoYJTSjTvOUVffoPuk5zjjWeYZLKTkrSyko9O1Iup1IyjLfPUGIOZZpDmeZXmRV-8uf7t-jv9ipAj8BXH2D_H5V5v1xdHaU_AeNprew</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2515755065</pqid></control><display><type>article</type><title>Development and validation of point‐of‐care testing of albuminuria for early screening of chronic kidney disease</title><source>MEDLINE</source><source>DOAJ Directory of Open Access Journals</source><source>Access via Wiley Online Library</source><source>EZB-FREE-00999 freely available EZB journals</source><source>Wiley Online Library (Open Access Collection)</source><source>PubMed Central</source><creator>Vutthikraivit, Nuntanuj ; Kiatamornrak, Patcharakorn ; Boonkrai, Chatikorn ; Pisitkun, Trairak ; Komolpis, Kittinan ; Puthong, Songchan ; Lumlertgul, Nuttha ; Peerapornratana, Sadudee ; Thanawattano, Chusak ; Tungsanga, Somkanya ; Praditpornsilpa, Kearkiat ; Tungsanga, Kriang ; Eiam‐Ong, Somchai ; Srisawat, Nattachai</creator><creatorcontrib>Vutthikraivit, Nuntanuj ; Kiatamornrak, Patcharakorn ; Boonkrai, Chatikorn ; Pisitkun, Trairak ; Komolpis, Kittinan ; Puthong, Songchan ; Lumlertgul, Nuttha ; Peerapornratana, Sadudee ; Thanawattano, Chusak ; Tungsanga, Somkanya ; Praditpornsilpa, Kearkiat ; Tungsanga, Kriang ; Eiam‐Ong, Somchai ; Srisawat, Nattachai</creatorcontrib><description>Introduction
Chronic kidney disease (CKD) is a significant global health issue. As the prevalence of renal replacement therapy (RRT) in Thailand is increasing, early detection and management of CKD is the most important step to prevent CKD progression and the need for RRT. Current diagnostic tests for CKD are non‐specific and expensive. We aimed to develop and validate antibody‐based‐albumin point‐of‐care testing (POCT) to detect patients with impaired kidney function at early stage.
Methods
The prototype strip test was developed under the concept of competitive lateral flow immunochromatography assay, or strip test. Monoclonal antibodies (MAbs) to human serum albumin (HSA) were harvested from the hybridomas of spleen cells from immunized mice and mouse myeloma cells. Presence of MAbs was detected by enzyme‐linked immunosorbent assay (ELISA). Spot urine was obtained from patients with kidney disease, type I, or type II Diabetes Mellitus upon their visit at King Chulalongkorn Memorial Hospital during 2018–2019. All samples were analyzed for urine albumin with our POCT (CU microalbumin) and the other two commercial POCTs (Microalbu PHAN and MICRAL). The results were validated against standard method for urine microalbumin measurement. A urine microalbumin concentration of less than 20 ug/ml was defined as normal. The sensitivity, specificity, and predictive values were calculated in comparison with the standard laboratory method.
Result
A total of 100 adult patients were included. CU microalbumin had a sensitivity of 86%, a specificity of 94%, and a positive predictive value of 96%. Our POCT showed good correlation with the laboratory results.
Conclusion
CU microalbumin correlated well with the standard method for quantitative measurement of urine albumin. Therefore, it has the potential for early screening of CKD, especially in primary health care facilities in resource limited settings.</description><identifier>ISSN: 0887-8013</identifier><identifier>EISSN: 1098-2825</identifier><identifier>DOI: 10.1002/jcla.23729</identifier><identifier>PMID: 33590941</identifier><language>eng</language><publisher>United States: John Wiley & Sons, Inc</publisher><subject>Age ; Albumin ; Albuminuria - diagnosis ; Animals ; Chromatography ; chronic kidney disease ; Cloning ; Diabetes mellitus ; Early Diagnosis ; Enzyme-linked immunosorbent assay ; Enzymes ; Female ; Human serum albumin ; Humans ; Immunoassay ; Kidney diseases ; Kinetics ; Mice ; Mice, Inbred BALB C ; microalbuminuria ; Monoclonal antibodies ; monoclonal antibody to albumin ; Myeloma ; Patients ; Point-of-Care Testing ; Proteins ; Public health ; Renal Insufficiency, Chronic - diagnosis ; Renal Insufficiency, Chronic - urine ; Serum Albumin, Human - urine ; Spleen ; Urine ; urine strip test</subject><ispartof>Journal of clinical laboratory analysis, 2021-04, Vol.35 (4), p.e23729-n/a</ispartof><rights>2021 The Authors. published by Wiley Periodicals LLC</rights><rights>2021 The Authors. Journal of Clinical Laboratory Analysis published by Wiley Periodicals LLC.</rights><rights>2021. This work is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4489-7836578f111558adf2eb5ca8b7bec432c4159dfe24b8346d540b40623aec8a623</citedby><cites>FETCH-LOGICAL-c4489-7836578f111558adf2eb5ca8b7bec432c4159dfe24b8346d540b40623aec8a623</cites><orcidid>0000-0002-8544-8132</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/PMC8059747/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8059747/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,885,1417,11562,27924,27925,45574,45575,46052,46476,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/33590941$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Vutthikraivit, Nuntanuj</creatorcontrib><creatorcontrib>Kiatamornrak, Patcharakorn</creatorcontrib><creatorcontrib>Boonkrai, Chatikorn</creatorcontrib><creatorcontrib>Pisitkun, Trairak</creatorcontrib><creatorcontrib>Komolpis, Kittinan</creatorcontrib><creatorcontrib>Puthong, Songchan</creatorcontrib><creatorcontrib>Lumlertgul, Nuttha</creatorcontrib><creatorcontrib>Peerapornratana, Sadudee</creatorcontrib><creatorcontrib>Thanawattano, Chusak</creatorcontrib><creatorcontrib>Tungsanga, Somkanya</creatorcontrib><creatorcontrib>Praditpornsilpa, Kearkiat</creatorcontrib><creatorcontrib>Tungsanga, Kriang</creatorcontrib><creatorcontrib>Eiam‐Ong, Somchai</creatorcontrib><creatorcontrib>Srisawat, Nattachai</creatorcontrib><title>Development and validation of point‐of‐care testing of albuminuria for early screening of chronic kidney disease</title><title>Journal of clinical laboratory analysis</title><addtitle>J Clin Lab Anal</addtitle><description>Introduction
Chronic kidney disease (CKD) is a significant global health issue. As the prevalence of renal replacement therapy (RRT) in Thailand is increasing, early detection and management of CKD is the most important step to prevent CKD progression and the need for RRT. Current diagnostic tests for CKD are non‐specific and expensive. We aimed to develop and validate antibody‐based‐albumin point‐of‐care testing (POCT) to detect patients with impaired kidney function at early stage.
Methods
The prototype strip test was developed under the concept of competitive lateral flow immunochromatography assay, or strip test. Monoclonal antibodies (MAbs) to human serum albumin (HSA) were harvested from the hybridomas of spleen cells from immunized mice and mouse myeloma cells. Presence of MAbs was detected by enzyme‐linked immunosorbent assay (ELISA). Spot urine was obtained from patients with kidney disease, type I, or type II Diabetes Mellitus upon their visit at King Chulalongkorn Memorial Hospital during 2018–2019. All samples were analyzed for urine albumin with our POCT (CU microalbumin) and the other two commercial POCTs (Microalbu PHAN and MICRAL). The results were validated against standard method for urine microalbumin measurement. A urine microalbumin concentration of less than 20 ug/ml was defined as normal. The sensitivity, specificity, and predictive values were calculated in comparison with the standard laboratory method.
Result
A total of 100 adult patients were included. CU microalbumin had a sensitivity of 86%, a specificity of 94%, and a positive predictive value of 96%. Our POCT showed good correlation with the laboratory results.
Conclusion
CU microalbumin correlated well with the standard method for quantitative measurement of urine albumin. Therefore, it has the potential for early screening of CKD, especially in primary health care facilities in resource limited settings.</description><subject>Age</subject><subject>Albumin</subject><subject>Albuminuria - diagnosis</subject><subject>Animals</subject><subject>Chromatography</subject><subject>chronic kidney disease</subject><subject>Cloning</subject><subject>Diabetes mellitus</subject><subject>Early Diagnosis</subject><subject>Enzyme-linked immunosorbent assay</subject><subject>Enzymes</subject><subject>Female</subject><subject>Human serum albumin</subject><subject>Humans</subject><subject>Immunoassay</subject><subject>Kidney diseases</subject><subject>Kinetics</subject><subject>Mice</subject><subject>Mice, Inbred BALB C</subject><subject>microalbuminuria</subject><subject>Monoclonal antibodies</subject><subject>monoclonal antibody to albumin</subject><subject>Myeloma</subject><subject>Patients</subject><subject>Point-of-Care Testing</subject><subject>Proteins</subject><subject>Public health</subject><subject>Renal Insufficiency, Chronic - diagnosis</subject><subject>Renal Insufficiency, Chronic - urine</subject><subject>Serum Albumin, Human - urine</subject><subject>Spleen</subject><subject>Urine</subject><subject>urine strip test</subject><issn>0887-8013</issn><issn>1098-2825</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2021</creationdate><recordtype>article</recordtype><sourceid>24P</sourceid><sourceid>WIN</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><recordid>eNp9kcuKFDEUhoMoTju68QEk4GYQasy1KtkIQ3unwY2uQyp1aiZtOmmTqpbe-Qg-o09i2m4HdeHmnMX5-Dg_P0KPKbmkhLDnaxfsJeMd03fQghKtGqaYvIsWRKmuUYTyM_SglDUhRGna3kdnnEtNtKALNL2EHYS03UCcsI0D3tngBzv5FHEa8Tb5OP349j2NdTibAU9QJh-vD0cb-nnj45y9xWPKGGwOe1xcBognxN3kFL3Dn_0QYY8HX8AWeIjujTYUeHTa5-jT61cfl2-b1Yc375ZXq8YJoXTTKd7KTo2UUimVHUYGvXRW9V0PTnDmBJV6GIGJXnHRDlKQXpCWcQtO2brP0Yujdzv3GxhczZhtMNvsNzbvTbLe_H2J_sZcp51RROpOdFVwcRLk9GWuyc3GFwch2AhpLoYJTSjTvOUVffoPuk5zjjWeYZLKTkrSyko9O1Iup1IyjLfPUGIOZZpDmeZXmRV-8uf7t-jv9ipAj8BXH2D_H5V5v1xdHaU_AeNprew</recordid><startdate>202104</startdate><enddate>202104</enddate><creator>Vutthikraivit, Nuntanuj</creator><creator>Kiatamornrak, Patcharakorn</creator><creator>Boonkrai, Chatikorn</creator><creator>Pisitkun, Trairak</creator><creator>Komolpis, Kittinan</creator><creator>Puthong, Songchan</creator><creator>Lumlertgul, Nuttha</creator><creator>Peerapornratana, Sadudee</creator><creator>Thanawattano, Chusak</creator><creator>Tungsanga, Somkanya</creator><creator>Praditpornsilpa, Kearkiat</creator><creator>Tungsanga, Kriang</creator><creator>Eiam‐Ong, Somchai</creator><creator>Srisawat, Nattachai</creator><general>John Wiley & Sons, Inc</general><general>John Wiley and Sons Inc</general><scope>24P</scope><scope>WIN</scope><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>3V.</scope><scope>7QP</scope><scope>7T5</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>LK8</scope><scope>M0S</scope><scope>M7P</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-8544-8132</orcidid></search><sort><creationdate>202104</creationdate><title>Development and validation of point‐of‐care testing of albuminuria for early screening of chronic kidney disease</title><author>Vutthikraivit, Nuntanuj ; Kiatamornrak, Patcharakorn ; Boonkrai, Chatikorn ; Pisitkun, Trairak ; Komolpis, Kittinan ; Puthong, Songchan ; Lumlertgul, Nuttha ; Peerapornratana, Sadudee ; Thanawattano, Chusak ; Tungsanga, Somkanya ; Praditpornsilpa, Kearkiat ; Tungsanga, Kriang ; Eiam‐Ong, Somchai ; Srisawat, Nattachai</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4489-7836578f111558adf2eb5ca8b7bec432c4159dfe24b8346d540b40623aec8a623</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2021</creationdate><topic>Age</topic><topic>Albumin</topic><topic>Albuminuria - diagnosis</topic><topic>Animals</topic><topic>Chromatography</topic><topic>chronic kidney disease</topic><topic>Cloning</topic><topic>Diabetes mellitus</topic><topic>Early Diagnosis</topic><topic>Enzyme-linked immunosorbent assay</topic><topic>Enzymes</topic><topic>Female</topic><topic>Human serum albumin</topic><topic>Humans</topic><topic>Immunoassay</topic><topic>Kidney diseases</topic><topic>Kinetics</topic><topic>Mice</topic><topic>Mice, Inbred BALB C</topic><topic>microalbuminuria</topic><topic>Monoclonal antibodies</topic><topic>monoclonal antibody to albumin</topic><topic>Myeloma</topic><topic>Patients</topic><topic>Point-of-Care Testing</topic><topic>Proteins</topic><topic>Public health</topic><topic>Renal Insufficiency, Chronic - diagnosis</topic><topic>Renal Insufficiency, Chronic - urine</topic><topic>Serum Albumin, Human - urine</topic><topic>Spleen</topic><topic>Urine</topic><topic>urine strip test</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Vutthikraivit, Nuntanuj</creatorcontrib><creatorcontrib>Kiatamornrak, Patcharakorn</creatorcontrib><creatorcontrib>Boonkrai, Chatikorn</creatorcontrib><creatorcontrib>Pisitkun, Trairak</creatorcontrib><creatorcontrib>Komolpis, Kittinan</creatorcontrib><creatorcontrib>Puthong, Songchan</creatorcontrib><creatorcontrib>Lumlertgul, Nuttha</creatorcontrib><creatorcontrib>Peerapornratana, Sadudee</creatorcontrib><creatorcontrib>Thanawattano, Chusak</creatorcontrib><creatorcontrib>Tungsanga, Somkanya</creatorcontrib><creatorcontrib>Praditpornsilpa, Kearkiat</creatorcontrib><creatorcontrib>Tungsanga, Kriang</creatorcontrib><creatorcontrib>Eiam‐Ong, Somchai</creatorcontrib><creatorcontrib>Srisawat, Nattachai</creatorcontrib><collection>Wiley Online Library (Open Access Collection)</collection><collection>Wiley Online Library Free Content</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Calcium & Calcified Tissue Abstracts</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Public Health Database</collection><collection>ProQuest SciTech 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>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</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>ProQuest Biological Science Collection</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Biological Science Database</collection><collection>Access via ProQuest (Open Access)</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central China</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of clinical laboratory analysis</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Vutthikraivit, Nuntanuj</au><au>Kiatamornrak, Patcharakorn</au><au>Boonkrai, Chatikorn</au><au>Pisitkun, Trairak</au><au>Komolpis, Kittinan</au><au>Puthong, Songchan</au><au>Lumlertgul, Nuttha</au><au>Peerapornratana, Sadudee</au><au>Thanawattano, Chusak</au><au>Tungsanga, Somkanya</au><au>Praditpornsilpa, Kearkiat</au><au>Tungsanga, Kriang</au><au>Eiam‐Ong, Somchai</au><au>Srisawat, Nattachai</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Development and validation of point‐of‐care testing of albuminuria for early screening of chronic kidney disease</atitle><jtitle>Journal of clinical laboratory analysis</jtitle><addtitle>J Clin Lab Anal</addtitle><date>2021-04</date><risdate>2021</risdate><volume>35</volume><issue>4</issue><spage>e23729</spage><epage>n/a</epage><pages>e23729-n/a</pages><issn>0887-8013</issn><eissn>1098-2825</eissn><abstract>Introduction
Chronic kidney disease (CKD) is a significant global health issue. As the prevalence of renal replacement therapy (RRT) in Thailand is increasing, early detection and management of CKD is the most important step to prevent CKD progression and the need for RRT. Current diagnostic tests for CKD are non‐specific and expensive. We aimed to develop and validate antibody‐based‐albumin point‐of‐care testing (POCT) to detect patients with impaired kidney function at early stage.
Methods
The prototype strip test was developed under the concept of competitive lateral flow immunochromatography assay, or strip test. Monoclonal antibodies (MAbs) to human serum albumin (HSA) were harvested from the hybridomas of spleen cells from immunized mice and mouse myeloma cells. Presence of MAbs was detected by enzyme‐linked immunosorbent assay (ELISA). Spot urine was obtained from patients with kidney disease, type I, or type II Diabetes Mellitus upon their visit at King Chulalongkorn Memorial Hospital during 2018–2019. All samples were analyzed for urine albumin with our POCT (CU microalbumin) and the other two commercial POCTs (Microalbu PHAN and MICRAL). The results were validated against standard method for urine microalbumin measurement. A urine microalbumin concentration of less than 20 ug/ml was defined as normal. The sensitivity, specificity, and predictive values were calculated in comparison with the standard laboratory method.
Result
A total of 100 adult patients were included. CU microalbumin had a sensitivity of 86%, a specificity of 94%, and a positive predictive value of 96%. Our POCT showed good correlation with the laboratory results.
Conclusion
CU microalbumin correlated well with the standard method for quantitative measurement of urine albumin. Therefore, it has the potential for early screening of CKD, especially in primary health care facilities in resource limited settings.</abstract><cop>United States</cop><pub>John Wiley & Sons, Inc</pub><pmid>33590941</pmid><doi>10.1002/jcla.23729</doi><tpages>10</tpages><orcidid>https://orcid.org/0000-0002-8544-8132</orcidid><oa>free_for_read</oa></addata></record> |
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| issn | 0887-8013 1098-2825 |
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| source | MEDLINE; DOAJ Directory of Open Access Journals; Access via Wiley Online Library; EZB-FREE-00999 freely available EZB journals; Wiley Online Library (Open Access Collection); PubMed Central |
| subjects | Age Albumin Albuminuria - diagnosis Animals Chromatography chronic kidney disease Cloning Diabetes mellitus Early Diagnosis Enzyme-linked immunosorbent assay Enzymes Female Human serum albumin Humans Immunoassay Kidney diseases Kinetics Mice Mice, Inbred BALB C microalbuminuria Monoclonal antibodies monoclonal antibody to albumin Myeloma Patients Point-of-Care Testing Proteins Public health Renal Insufficiency, Chronic - diagnosis Renal Insufficiency, Chronic - urine Serum Albumin, Human - urine Spleen Urine urine strip test |
| title | Development and validation of point‐of‐care testing of albuminuria for early screening of chronic kidney disease |
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