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Haemoglobin variants may cause significant differences in haemoglobin A1c as measured by high-performance liquid chromatography and enzymatic methods in diabetic patients: a cross-sectional study
Background We aimed to determine whether the discrepancy between haemoglobin A1c values determined by high-performance liquid chromatography and enzymatic haemoglobin A1c measurements in diabetic patients was clinically relevant. Methods We randomly recruited 1421 outpatients undergoing diabetic tre...
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| Published in: | Annals of clinical biochemistry 2017-07, Vol.54 (4), p.432-437 |
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| cites | cdi_FETCH-LOGICAL-c337t-e53d7aff0abd5828331ae881b529aa1774e48069f74962d490ce7d600430c89c3 |
| container_end_page | 437 |
| container_issue | 4 |
| container_start_page | 432 |
| container_title | Annals of clinical biochemistry |
| container_volume | 54 |
| creator | Otabe, Shuichi Nakayama, Hitomi Ohki, Tsuyoshi Soejima, Eri Tajiri, Yuji Yamada, Kentaro |
| description | Background
We aimed to determine whether the discrepancy between haemoglobin A1c values determined by high-performance liquid chromatography and enzymatic haemoglobin A1c measurements in diabetic patients was clinically relevant.
Methods
We randomly recruited 1421 outpatients undergoing diabetic treatment and follow-up who underwent at least three haemoglobin A1c measurements between April 2014 and March 2015 at our clinic. In 6369 samples, haemoglobin A1c was simultaneously measured by HA-8160 and MetaboLead (enzymatic assay), and the values were compared.
Results
haemoglobin A1c measurements by high-performance liquid chromatography and enzymatic assay were strongly correlated (correlation coefficient: 0.9828, linear approximation curve y = 0.9986x − 0.2507). Mean haemoglobin A1c (6.8 ± 1.0%) measured by high-performance liquid chromatography was significantly higher than that measured by enzymatic assay (6.5 ± 1.0%, P C) mutation in the δ-globin gene. These unrelated asymptomatic subjects had normal erythrocyte profiles, without anaemia.
Conclusions
We showed that haemoglobin A1c values measured by high-performance liquid chromatography were significantly higher than those measured by enzymatic assay in diabetic subjects. However, when an oversized deviation (>0.7%) between glycaemic control status and haemoglobin A1c is apparent, clinicians should check the methods used to measure haemoglobin A1c and consider the possible presence of a haemoglobin variant. |
| doi_str_mv | 10.1177/0004563216664366 |
| format | article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_1859711722</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sage_id>10.1177_0004563216664366</sage_id><sourcerecordid>1859711722</sourcerecordid><originalsourceid>FETCH-LOGICAL-c337t-e53d7aff0abd5828331ae881b529aa1774e48069f74962d490ce7d600430c89c3</originalsourceid><addsrcrecordid>eNp1UU9r1zAYDqK4n5t3T5Kjl86kaZPW2xi6CYNd3Lm8Td60GW3TJa3QfT2_mOl-U0TYKeT5x8vzEPKBs3POlfrMGCtKKXIupSyElK_Igauyyjhj_DU57HS28yfkXYz36Zsrxt6Sk1wVtVR1fiC_rgFH3w2-dRP9CcHBtEQ6wkY1rBFpdN3krNMJpsZZiwEnjZEmdf-P84JrCsmHENeAhrYb7V3XZzMG68MIyUMH97A6Q3Uf_AiL7wLM_UZhMhSnxy1BTqeApffmKd44aHHH5sRguuoLBaqDjzGLqBfnJxhoXFaznZE3FoaI75_fU3L37euPy-vs5vbq--XFTaaFUEuGpTAKrGXQmrLKKyE4YFXxtsxrgFRngUXFZG33cnJT1EyjMjJ1KJiuai1Oyadj7hz8w4pxaUYXNQ4DTOjX2PCqrFXaJc-TlB2lTwcHtM0c3Ahhazhr9uma_6dLlo_P6Ws7ovlr-LNVEmRHQYQOm3u_htRAfDnwN_x7pU4</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1859711722</pqid></control><display><type>article</type><title>Haemoglobin variants may cause significant differences in haemoglobin A1c as measured by high-performance liquid chromatography and enzymatic methods in diabetic patients: a cross-sectional study</title><source>Sage Journals Online</source><creator>Otabe, Shuichi ; Nakayama, Hitomi ; Ohki, Tsuyoshi ; Soejima, Eri ; Tajiri, Yuji ; Yamada, Kentaro</creator><creatorcontrib>Otabe, Shuichi ; Nakayama, Hitomi ; Ohki, Tsuyoshi ; Soejima, Eri ; Tajiri, Yuji ; Yamada, Kentaro</creatorcontrib><description>Background
We aimed to determine whether the discrepancy between haemoglobin A1c values determined by high-performance liquid chromatography and enzymatic haemoglobin A1c measurements in diabetic patients was clinically relevant.
Methods
We randomly recruited 1421 outpatients undergoing diabetic treatment and follow-up who underwent at least three haemoglobin A1c measurements between April 2014 and March 2015 at our clinic. In 6369 samples, haemoglobin A1c was simultaneously measured by HA-8160 and MetaboLead (enzymatic assay), and the values were compared.
Results
haemoglobin A1c measurements by high-performance liquid chromatography and enzymatic assay were strongly correlated (correlation coefficient: 0.9828, linear approximation curve y = 0.9986x − 0.2507). Mean haemoglobin A1c (6.8 ± 1.0%) measured by high-performance liquid chromatography was significantly higher than that measured by enzymatic assay (6.5 ± 1.0%, P < 0.0001). During the sample processing, four (0.3%) subjects presented consistently lower haemoglobin A1c values (<0.7%) by high-performance liquid chromatography than those from enzymatic assay. Of these, three had Hb Toranomon [β112 (G14) Cys→Trp]. The fourth had Hb Ube-2 [α68 (E17) Asn→Asp]. One other subject presented consistently higher haemoglobin A1c values (>1%) by high-performance liquid chromatography than those from enzymatic assay and was diagnosed with a −77 (T > C) mutation in the δ-globin gene. These unrelated asymptomatic subjects had normal erythrocyte profiles, without anaemia.
Conclusions
We showed that haemoglobin A1c values measured by high-performance liquid chromatography were significantly higher than those measured by enzymatic assay in diabetic subjects. However, when an oversized deviation (>0.7%) between glycaemic control status and haemoglobin A1c is apparent, clinicians should check the methods used to measure haemoglobin A1c and consider the possible presence of a haemoglobin variant.</description><identifier>ISSN: 0004-5632</identifier><identifier>EISSN: 1758-1001</identifier><identifier>DOI: 10.1177/0004563216664366</identifier><identifier>PMID: 27496792</identifier><language>eng</language><publisher>London, England: SAGE Publications</publisher><subject>Adult ; Aged ; Chromatography, High Pressure Liquid - statistics & numerical data ; Diabetes Mellitus - blood ; Diabetes Mellitus - diagnosis ; Enzyme Assays - statistics & numerical data ; Female ; gamma-Globins - analysis ; gamma-Globins - genetics ; Gene Expression ; Glycated Hemoglobin A - analysis ; Glycated Hemoglobin A - genetics ; Hemoglobins, Abnormal - analysis ; Hemoglobins, Abnormal - genetics ; Humans ; Male ; Middle Aged ; Mutation ; Outpatients ; Quality Control ; Sensitivity and Specificity</subject><ispartof>Annals of clinical biochemistry, 2017-07, Vol.54 (4), p.432-437</ispartof><rights>The Author(s) 2016</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c337t-e53d7aff0abd5828331ae881b529aa1774e48069f74962d490ce7d600430c89c3</citedby><cites>FETCH-LOGICAL-c337t-e53d7aff0abd5828331ae881b529aa1774e48069f74962d490ce7d600430c89c3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925,79364</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/27496792$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Otabe, Shuichi</creatorcontrib><creatorcontrib>Nakayama, Hitomi</creatorcontrib><creatorcontrib>Ohki, Tsuyoshi</creatorcontrib><creatorcontrib>Soejima, Eri</creatorcontrib><creatorcontrib>Tajiri, Yuji</creatorcontrib><creatorcontrib>Yamada, Kentaro</creatorcontrib><title>Haemoglobin variants may cause significant differences in haemoglobin A1c as measured by high-performance liquid chromatography and enzymatic methods in diabetic patients: a cross-sectional study</title><title>Annals of clinical biochemistry</title><addtitle>Ann Clin Biochem</addtitle><description>Background
We aimed to determine whether the discrepancy between haemoglobin A1c values determined by high-performance liquid chromatography and enzymatic haemoglobin A1c measurements in diabetic patients was clinically relevant.
Methods
We randomly recruited 1421 outpatients undergoing diabetic treatment and follow-up who underwent at least three haemoglobin A1c measurements between April 2014 and March 2015 at our clinic. In 6369 samples, haemoglobin A1c was simultaneously measured by HA-8160 and MetaboLead (enzymatic assay), and the values were compared.
Results
haemoglobin A1c measurements by high-performance liquid chromatography and enzymatic assay were strongly correlated (correlation coefficient: 0.9828, linear approximation curve y = 0.9986x − 0.2507). Mean haemoglobin A1c (6.8 ± 1.0%) measured by high-performance liquid chromatography was significantly higher than that measured by enzymatic assay (6.5 ± 1.0%, P < 0.0001). During the sample processing, four (0.3%) subjects presented consistently lower haemoglobin A1c values (<0.7%) by high-performance liquid chromatography than those from enzymatic assay. Of these, three had Hb Toranomon [β112 (G14) Cys→Trp]. The fourth had Hb Ube-2 [α68 (E17) Asn→Asp]. One other subject presented consistently higher haemoglobin A1c values (>1%) by high-performance liquid chromatography than those from enzymatic assay and was diagnosed with a −77 (T > C) mutation in the δ-globin gene. These unrelated asymptomatic subjects had normal erythrocyte profiles, without anaemia.
Conclusions
We showed that haemoglobin A1c values measured by high-performance liquid chromatography were significantly higher than those measured by enzymatic assay in diabetic subjects. However, when an oversized deviation (>0.7%) between glycaemic control status and haemoglobin A1c is apparent, clinicians should check the methods used to measure haemoglobin A1c and consider the possible presence of a haemoglobin variant.</description><subject>Adult</subject><subject>Aged</subject><subject>Chromatography, High Pressure Liquid - statistics & numerical data</subject><subject>Diabetes Mellitus - blood</subject><subject>Diabetes Mellitus - diagnosis</subject><subject>Enzyme Assays - statistics & numerical data</subject><subject>Female</subject><subject>gamma-Globins - analysis</subject><subject>gamma-Globins - genetics</subject><subject>Gene Expression</subject><subject>Glycated Hemoglobin A - analysis</subject><subject>Glycated Hemoglobin A - genetics</subject><subject>Hemoglobins, Abnormal - analysis</subject><subject>Hemoglobins, Abnormal - genetics</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Mutation</subject><subject>Outpatients</subject><subject>Quality Control</subject><subject>Sensitivity and Specificity</subject><issn>0004-5632</issn><issn>1758-1001</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><recordid>eNp1UU9r1zAYDqK4n5t3T5Kjl86kaZPW2xi6CYNd3Lm8Td60GW3TJa3QfT2_mOl-U0TYKeT5x8vzEPKBs3POlfrMGCtKKXIupSyElK_Igauyyjhj_DU57HS28yfkXYz36Zsrxt6Sk1wVtVR1fiC_rgFH3w2-dRP9CcHBtEQ6wkY1rBFpdN3krNMJpsZZiwEnjZEmdf-P84JrCsmHENeAhrYb7V3XZzMG68MIyUMH97A6Q3Uf_AiL7wLM_UZhMhSnxy1BTqeApffmKd44aHHH5sRguuoLBaqDjzGLqBfnJxhoXFaznZE3FoaI75_fU3L37euPy-vs5vbq--XFTaaFUEuGpTAKrGXQmrLKKyE4YFXxtsxrgFRngUXFZG33cnJT1EyjMjJ1KJiuai1Oyadj7hz8w4pxaUYXNQ4DTOjX2PCqrFXaJc-TlB2lTwcHtM0c3Ahhazhr9uma_6dLlo_P6Ws7ovlr-LNVEmRHQYQOm3u_htRAfDnwN_x7pU4</recordid><startdate>201707</startdate><enddate>201707</enddate><creator>Otabe, Shuichi</creator><creator>Nakayama, Hitomi</creator><creator>Ohki, Tsuyoshi</creator><creator>Soejima, Eri</creator><creator>Tajiri, Yuji</creator><creator>Yamada, Kentaro</creator><general>SAGE Publications</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>7X8</scope></search><sort><creationdate>201707</creationdate><title>Haemoglobin variants may cause significant differences in haemoglobin A1c as measured by high-performance liquid chromatography and enzymatic methods in diabetic patients: a cross-sectional study</title><author>Otabe, Shuichi ; Nakayama, Hitomi ; Ohki, Tsuyoshi ; Soejima, Eri ; Tajiri, Yuji ; Yamada, Kentaro</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c337t-e53d7aff0abd5828331ae881b529aa1774e48069f74962d490ce7d600430c89c3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Chromatography, High Pressure Liquid - statistics & numerical data</topic><topic>Diabetes Mellitus - blood</topic><topic>Diabetes Mellitus - diagnosis</topic><topic>Enzyme Assays - statistics & numerical data</topic><topic>Female</topic><topic>gamma-Globins - analysis</topic><topic>gamma-Globins - genetics</topic><topic>Gene Expression</topic><topic>Glycated Hemoglobin A - analysis</topic><topic>Glycated Hemoglobin A - genetics</topic><topic>Hemoglobins, Abnormal - analysis</topic><topic>Hemoglobins, Abnormal - genetics</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Mutation</topic><topic>Outpatients</topic><topic>Quality Control</topic><topic>Sensitivity and Specificity</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Otabe, Shuichi</creatorcontrib><creatorcontrib>Nakayama, Hitomi</creatorcontrib><creatorcontrib>Ohki, Tsuyoshi</creatorcontrib><creatorcontrib>Soejima, Eri</creatorcontrib><creatorcontrib>Tajiri, Yuji</creatorcontrib><creatorcontrib>Yamada, Kentaro</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Annals of clinical biochemistry</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Otabe, Shuichi</au><au>Nakayama, Hitomi</au><au>Ohki, Tsuyoshi</au><au>Soejima, Eri</au><au>Tajiri, Yuji</au><au>Yamada, Kentaro</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Haemoglobin variants may cause significant differences in haemoglobin A1c as measured by high-performance liquid chromatography and enzymatic methods in diabetic patients: a cross-sectional study</atitle><jtitle>Annals of clinical biochemistry</jtitle><addtitle>Ann Clin Biochem</addtitle><date>2017-07</date><risdate>2017</risdate><volume>54</volume><issue>4</issue><spage>432</spage><epage>437</epage><pages>432-437</pages><issn>0004-5632</issn><eissn>1758-1001</eissn><abstract>Background
We aimed to determine whether the discrepancy between haemoglobin A1c values determined by high-performance liquid chromatography and enzymatic haemoglobin A1c measurements in diabetic patients was clinically relevant.
Methods
We randomly recruited 1421 outpatients undergoing diabetic treatment and follow-up who underwent at least three haemoglobin A1c measurements between April 2014 and March 2015 at our clinic. In 6369 samples, haemoglobin A1c was simultaneously measured by HA-8160 and MetaboLead (enzymatic assay), and the values were compared.
Results
haemoglobin A1c measurements by high-performance liquid chromatography and enzymatic assay were strongly correlated (correlation coefficient: 0.9828, linear approximation curve y = 0.9986x − 0.2507). Mean haemoglobin A1c (6.8 ± 1.0%) measured by high-performance liquid chromatography was significantly higher than that measured by enzymatic assay (6.5 ± 1.0%, P < 0.0001). During the sample processing, four (0.3%) subjects presented consistently lower haemoglobin A1c values (<0.7%) by high-performance liquid chromatography than those from enzymatic assay. Of these, three had Hb Toranomon [β112 (G14) Cys→Trp]. The fourth had Hb Ube-2 [α68 (E17) Asn→Asp]. One other subject presented consistently higher haemoglobin A1c values (>1%) by high-performance liquid chromatography than those from enzymatic assay and was diagnosed with a −77 (T > C) mutation in the δ-globin gene. These unrelated asymptomatic subjects had normal erythrocyte profiles, without anaemia.
Conclusions
We showed that haemoglobin A1c values measured by high-performance liquid chromatography were significantly higher than those measured by enzymatic assay in diabetic subjects. However, when an oversized deviation (>0.7%) between glycaemic control status and haemoglobin A1c is apparent, clinicians should check the methods used to measure haemoglobin A1c and consider the possible presence of a haemoglobin variant.</abstract><cop>London, England</cop><pub>SAGE Publications</pub><pmid>27496792</pmid><doi>10.1177/0004563216664366</doi><tpages>6</tpages></addata></record> |
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| ispartof | Annals of clinical biochemistry, 2017-07, Vol.54 (4), p.432-437 |
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| source | Sage Journals Online |
| subjects | Adult Aged Chromatography, High Pressure Liquid - statistics & numerical data Diabetes Mellitus - blood Diabetes Mellitus - diagnosis Enzyme Assays - statistics & numerical data Female gamma-Globins - analysis gamma-Globins - genetics Gene Expression Glycated Hemoglobin A - analysis Glycated Hemoglobin A - genetics Hemoglobins, Abnormal - analysis Hemoglobins, Abnormal - genetics Humans Male Middle Aged Mutation Outpatients Quality Control Sensitivity and Specificity |
| title | Haemoglobin variants may cause significant differences in haemoglobin A1c as measured by high-performance liquid chromatography and enzymatic methods in diabetic patients: a cross-sectional study |
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