{"id":"https://openalex.org/W7202070920","doi":"https://doi.org/10.25259/jlp_31_2026","title":"Analytical performance evaluation of commercially available hepatitis A virus IgM immunoassays: ELISA, ICTs, and chemiluminescence immunoassay","display_name":"Analytical performance evaluation of commercially available hepatitis A virus IgM immunoassays: ELISA, ICTs, and chemiluminescence immunoassay","publication_year":2026,"publication_date":"2026-08-10","ids":{"openalex":"https://openalex.org/W7202070920","doi":"https://doi.org/10.25259/jlp_31_2026"},"language":"en","primary_location":{"id":"doi:10.25259/jlp_31_2026","doi":"https://doi.org/10.25259/jlp_31_2026","is_oa":true,"landing_page_url":"https://doi.org/10.25259/jlp_31_2026","pdf_url":"https://jlabphy.org/content/164/2026/0/1/pdf/JLP-31-2026.pdf","source":{"id":"https://openalex.org/S4210187584","display_name":"Journal of Laboratory Physicians","issn_l":"0974-2727","issn":["0974-2727","0974-7826"],"is_oa":true,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","poland-20","russia-white-list-2"],"host_organization":"https://openalex.org/P4310320000","host_organization_name":"Thieme Medical Publishers (Germany)","host_organization_lineage":["https://openalex.org/P4310320000"],"host_organization_lineage_names":["Thieme Medical Publishers (Germany)"],"type":"journal"},"license":"cc-by-nc-sa","license_id":"https://openalex.org/licenses/cc-by-nc-sa","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Laboratory Physicians","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref"],"open_access":{"is_oa":true,"oa_status":"gold","oa_url":"https://jlabphy.org/content/164/2026/0/1/pdf/JLP-31-2026.pdf","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5101134762","display_name":"Rajeev Kumar Jain","orcid":"https://orcid.org/0000-0002-8157-7914","observed_orcids":["https://orcid.org/0000-0002-8157-7914"]},"institutions":[{"id":"https://openalex.org/I4210151372","display_name":"Gandhi Medical College","ror":"https://ror.org/04npss011","country_code":"IN","type":"healthcare","lineage":["https://openalex.org/I4210151372"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Rajeev Kumar Jain","raw_affiliation_strings":["State Virology Laboratory, Gandhi Medical College, Bhopal, Madhya Pradesh, India,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"State Virology Laboratory, Gandhi Medical College, Bhopal, Madhya Pradesh, India,","institution_ids":["https://openalex.org/I4210151372"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5104019131","display_name":"Rakesh Kumar Shrivastava","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210151372","display_name":"Gandhi Medical College","ror":"https://ror.org/04npss011","country_code":"IN","type":"healthcare","lineage":["https://openalex.org/I4210151372"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Rakesh Kumar Shrivastava","raw_affiliation_strings":["Department of Microbiology, Gandhi Medical College, Bhopal, Madhya Pradesh, India,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Microbiology, Gandhi Medical College, Bhopal, Madhya Pradesh, India,","institution_ids":["https://openalex.org/I4210151372"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5039793037","display_name":"Ankita Agarwal","orcid":"https://orcid.org/0000-0002-7356-4507","observed_orcids":["https://orcid.org/0000-0002-7356-4507"]},"institutions":[{"id":"https://openalex.org/I4210151372","display_name":"Gandhi Medical College","ror":"https://ror.org/04npss011","country_code":"IN","type":"healthcare","lineage":["https://openalex.org/I4210151372"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Ankita Agarwal","raw_affiliation_strings":["State Virology Laboratory, Gandhi Medical College, Bhopal, Madhya Pradesh, India,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"State Virology Laboratory, Gandhi Medical College, Bhopal, Madhya Pradesh, India,","institution_ids":["https://openalex.org/I4210151372"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5032033783","display_name":"Kamlesh Kumar Ahirwar","orcid":"https://orcid.org/0009-0001-4876-3846","observed_orcids":["https://orcid.org/0009-0001-4876-3846"]},"institutions":[{"id":"https://openalex.org/I4210151372","display_name":"Gandhi Medical College","ror":"https://ror.org/04npss011","country_code":"IN","type":"healthcare","lineage":["https://openalex.org/I4210151372"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Kamlesh Kumar Ahirwar","raw_affiliation_strings":["State Virology Laboratory, Gandhi Medical College, Bhopal, Madhya Pradesh, India,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"State Virology Laboratory, Gandhi Medical College, Bhopal, Madhya Pradesh, India,","institution_ids":["https://openalex.org/I4210151372"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5038860348","display_name":"Deepti Chaurasia","orcid":"https://orcid.org/0000-0001-5780-5254","observed_orcids":["https://orcid.org/0000-0001-5780-5254"]},"institutions":[{"id":"https://openalex.org/I4210151372","display_name":"Gandhi Medical College","ror":"https://ror.org/04npss011","country_code":"IN","type":"healthcare","lineage":["https://openalex.org/I4210151372"]}],"countries":["IN"],"is_corresponding":false,"raw_author_name":"Deepti Chaurasia","raw_affiliation_strings":["Department of Microbiology, Gandhi Medical College, Bhopal, Madhya Pradesh, India,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Microbiology, Gandhi Medical College, Bhopal, Madhya Pradesh, India,","institution_ids":["https://openalex.org/I4210151372"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5055701607","display_name":"Nagaraj Perumal","orcid":"https://orcid.org/0000-0002-3545-4171","observed_orcids":["https://orcid.org/0000-0002-3545-4171"]},"institutions":[{"id":"https://openalex.org/I4210151372","display_name":"Gandhi Medical College","ror":"https://ror.org/04npss011","country_code":"IN","type":"healthcare","lineage":["https://openalex.org/I4210151372"]}],"countries":["IN"],"is_corresponding":true,"raw_author_name":"Nagaraj Perumal","raw_affiliation_strings":["State Virology Laboratory, Gandhi Medical College, Bhopal, Madhya Pradesh, India,"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"State Virology Laboratory, Gandhi Medical College, Bhopal, Madhya Pradesh, India,","institution_ids":["https://openalex.org/I4210151372"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":1,"corresponding_author_ids":["https://openalex.org/A5055701607"],"corresponding_institution_ids":["https://openalex.org/I4210151372"],"apc_list":{"value":200,"currency":"USD","value_usd":200},"apc_paid":{"value":200,"currency":"USD","value_usd":200},"fwci":0.0,"has_fulltext":true,"cited_by_count":0,"citation_normalized_percentile":{"value":0.0,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":"18","issue":null,"first_page":"422","last_page":"430"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T12025","display_name":"Hepatitis Viruses Studies and Epidemiology","score":0.9247999787330627,"subfield":{"id":"https://openalex.org/subfields/2721","display_name":"Hepatology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T12025","display_name":"Hepatitis Viruses Studies and Epidemiology","score":0.9247999787330627,"subfield":{"id":"https://openalex.org/subfields/2721","display_name":"Hepatology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11393","display_name":"Biosensors and Analytical Detection","score":0.019099999219179153,"subfield":{"id":"https://openalex.org/subfields/2204","display_name":"Biomedical Engineering"},"field":{"id":"https://openalex.org/fields/22","display_name":"Engineering"},"domain":{"id":"https://openalex.org/domains/3","display_name":"Physical Sciences"}},{"id":"https://openalex.org/T10976","display_name":"Viral gastroenteritis research and epidemiology","score":0.01720000058412552,"subfield":{"id":"https://openalex.org/subfields/2725","display_name":"Infectious Diseases"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/hepatitis-a-virus","display_name":"hepatitis A virus","score":0.9980000257492065},{"id":"https://openalex.org/keywords/igm","display_name":"IgM","score":0.6449999809265137},{"id":"https://openalex.org/keywords/elisa","display_name":"ELISA","score":0.8410000205039978},{"id":"https://openalex.org/keywords/rapid-immunochromatographic-test","display_name":"rapid immunochromatographic test","score":0.925000011920929},{"id":"https://openalex.org/keywords/chemiluminescence-immunoassay","display_name":"chemiluminescence immunoassay","score":0.9950000047683716},{"id":"https://openalex.org/keywords/reference-method-comparison","display_name":"reference method comparison","score":0.5090000033378601},{"id":"https://openalex.org/keywords/sensitivity-and-specificity","display_name":"sensitivity and specificity","score":0.8429999947547913}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.6301000118255615},{"id":"https://openalex.org/C2780420688","wikidata":"https://www.wikidata.org/wiki/Q759183","display_name":"Immunoassay","level":3,"score":0.5767999887466431},{"id":"https://openalex.org/C45189115","wikidata":"https://www.wikidata.org/wiki/Q502159","display_name":"Serology","level":3,"score":0.513700008392334},{"id":"https://openalex.org/C145802702","wikidata":"https://www.wikidata.org/wiki/Q2931725","display_name":"Chemiluminescence","level":2,"score":0.5109000205993652},{"id":"https://openalex.org/C160798450","wikidata":"https://www.wikidata.org/wiki/Q4230870","display_name":"Concordance","level":2,"score":0.48730000853538513},{"id":"https://openalex.org/C159047783","wikidata":"https://www.wikidata.org/wiki/Q7215","display_name":"Virology","level":1,"score":0.38960000872612},{"id":"https://openalex.org/C3019983190","wikidata":"https://www.wikidata.org/wiki/Q157661","display_name":"Hepatitis a virus","level":3,"score":0.38850000500679016},{"id":"https://openalex.org/C3019719930","wikidata":"https://www.wikidata.org/wiki/Q3910099","display_name":"Predictive value","level":2,"score":0.38690000772476196},{"id":"https://openalex.org/C2778724333","wikidata":"https://www.wikidata.org/wiki/Q14401","display_name":"Kappa","level":2,"score":0.35850000381469727},{"id":"https://openalex.org/C44249647","wikidata":"https://www.wikidata.org/wiki/Q208498","display_name":"Confidence interval","level":2,"score":0.3124000132083893},{"id":"https://openalex.org/C159654299","wikidata":"https://www.wikidata.org/wiki/Q79460","display_name":"Antibody","level":2,"score":0.3000999987125397},{"id":"https://openalex.org/C2994453816","wikidata":"https://www.wikidata.org/wiki/Q759183","display_name":"Chemiluminescent immunoassay","level":4,"score":0.2903999984264374},{"id":"https://openalex.org/C2522874641","wikidata":"https://www.wikidata.org/wiki/Q808","display_name":"Virus","level":2,"score":0.2897999882698059},{"id":"https://openalex.org/C2776553844","wikidata":"https://www.wikidata.org/wiki/Q79451","display_name":"Immunoglobulin M","level":4,"score":0.28220000863075256},{"id":"https://openalex.org/C203014093","wikidata":"https://www.wikidata.org/wiki/Q101929","display_name":"Immunology","level":1,"score":0.28130000829696655},{"id":"https://openalex.org/C3020132585","wikidata":"https://www.wikidata.org/wiki/Q2671652","display_name":"Diagnostic accuracy","level":2,"score":0.27810001373291016},{"id":"https://openalex.org/C2775876817","wikidata":"https://www.wikidata.org/wiki/Q157661","display_name":"Hepatitis A","level":3,"score":0.2777999937534332},{"id":"https://openalex.org/C154020017","wikidata":"https://www.wikidata.org/wiki/Q520171","display_name":"Repeatability","level":2,"score":0.27619999647140503},{"id":"https://openalex.org/C89838059","wikidata":"https://www.wikidata.org/wiki/Q623738","display_name":"Coefficient of variation","level":2,"score":0.2639000117778778},{"id":"https://openalex.org/C2777451964","wikidata":"https://www.wikidata.org/wiki/Q2141450","display_name":"Seroconversion","level":3,"score":0.2522999942302704},{"id":"https://openalex.org/C2777072776","wikidata":"https://www.wikidata.org/wiki/Q1983841","display_name":"Viral hepatitis","level":2,"score":0.251800000667572}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.25259/jlp_31_2026","doi":"https://doi.org/10.25259/jlp_31_2026","is_oa":true,"landing_page_url":"https://doi.org/10.25259/jlp_31_2026","pdf_url":"https://jlabphy.org/content/164/2026/0/1/pdf/JLP-31-2026.pdf","source":{"id":"https://openalex.org/S4210187584","display_name":"Journal of Laboratory Physicians","issn_l":"0974-2727","issn":["0974-2727","0974-7826"],"is_oa":true,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","poland-20","russia-white-list-2"],"host_organization":"https://openalex.org/P4310320000","host_organization_name":"Thieme Medical Publishers (Germany)","host_organization_lineage":["https://openalex.org/P4310320000"],"host_organization_lineage_names":["Thieme Medical Publishers (Germany)"],"type":"journal"},"license":"cc-by-nc-sa","license_id":"https://openalex.org/licenses/cc-by-nc-sa","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Laboratory Physicians","raw_type":"journal-article"}],"best_oa_location":{"id":"doi:10.25259/jlp_31_2026","doi":"https://doi.org/10.25259/jlp_31_2026","is_oa":true,"landing_page_url":"https://doi.org/10.25259/jlp_31_2026","pdf_url":"https://jlabphy.org/content/164/2026/0/1/pdf/JLP-31-2026.pdf","source":{"id":"https://openalex.org/S4210187584","display_name":"Journal of Laboratory Physicians","issn_l":"0974-2727","issn":["0974-2727","0974-7826"],"is_oa":true,"is_in_doaj":false,"is_core":true,"listed_in":["cwts-core","poland-20","russia-white-list-2"],"host_organization":"https://openalex.org/P4310320000","host_organization_name":"Thieme Medical Publishers (Germany)","host_organization_lineage":["https://openalex.org/P4310320000"],"host_organization_lineage_names":["Thieme Medical Publishers (Germany)"],"type":"journal"},"license":"cc-by-nc-sa","license_id":"https://openalex.org/licenses/cc-by-nc-sa","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Journal of Laboratory Physicians","raw_type":"journal-article"},"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","score":0.8999999761581421,"display_name":"Good health and well-being"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":true,"grobid_xml":true},"content_urls":{"pdf":"https://content.openalex.org/works/W7202070920.pdf","grobid_xml":"https://content.openalex.org/works/W7202070920.grobid-xml"},"referenced_works_count":22,"referenced_works":["https://openalex.org/W1489065511","https://openalex.org/W1978654037","https://openalex.org/W1998678731","https://openalex.org/W2063313528","https://openalex.org/W2091238369","https://openalex.org/W2117122657","https://openalex.org/W2337114621","https://openalex.org/W2554768185","https://openalex.org/W2787754419","https://openalex.org/W2792780083","https://openalex.org/W2914432742","https://openalex.org/W2975884448","https://openalex.org/W3021186559","https://openalex.org/W3022920345","https://openalex.org/W3040786956","https://openalex.org/W3197144319","https://openalex.org/W4232295757","https://openalex.org/W4233907537","https://openalex.org/W4295910803","https://openalex.org/W4313490200","https://openalex.org/W4399879439","https://openalex.org/W4402441678"],"related_works":["https://openalex.org/W2442467078","https://openalex.org/W7166167360","https://openalex.org/W2091238369","https://openalex.org/W7097540278","https://openalex.org/W4411612348","https://openalex.org/W2351555640","https://openalex.org/W2117122657","https://openalex.org/W1969910550","https://openalex.org/W4300002746","https://openalex.org/W2977383493"],"abstract_inverted_index":{"Objectives:":[0],"The":[1,45],"objective":[2],"of":[3,12,48,97,181,229,239],"the":[4,9,78,131,150,168,194,201],"study":[5],"is":[6],"to":[7,234],"evaluate":[8],"diagnostic":[10,46,230],"performance":[11,47,158],"commercially":[13,50,219],"available":[14,51,220],"hepatitis":[15],"A":[16,141],"virus":[17],"(HAV)":[18],"immunoglobulin":[19],"M":[20],"(IgM)":[21],"index":[22],"tests,":[23],"specifically":[24],"enzyme-linked":[25],"immunosorbent":[26],"assays":[27],"(ELISA)":[28],"and":[29,43,61,63,70,118,154,162,164,174,183,206,226],"rapid":[30,65,190],"immunochromatographic":[31],"tests":[32],"(ICTs),":[33],"against":[34],"a":[35,75],"chemiluminescence":[36],"immunoassay":[37],"(CLIA)":[38],"serological":[39],"reference":[40,79,132,169,202],"standard.":[41],"Materials":[42],"Methods:":[44],"four":[49],"HAV":[52,221,241],"IgM":[53,222],"ELISA":[54,151,176],"kits":[55,67,177,209],"(Dia.Pro,":[56],"MBS":[57,171],"New":[58,172],"S.R.L.,":[59],"Wantai,":[60],"Biogenix)":[62],"three":[64],"ICT":[66,191,208],"(Biogenix,":[68],"Biotrol,":[69],"Insight)":[71],"was":[72,84,107,134,144],"evaluated":[73],"using":[74,86,109,136],"CLIA":[76],"as":[77],"comparator.":[80,170],"An":[81],"initial":[82],"assessment":[83],"conducted":[85],"48":[87],"well-characterized":[88],"external":[89],"quality":[90],"assurance":[91],"serum":[92,101],"samples,":[93],"followed":[94],"by":[95],"evaluation":[96,225],"250":[98],"residual":[99],"clinical":[100],"samples.":[102],"Statistical":[103,105,111],"analysis:":[104],"analysis":[106],"performed":[108],"MedCalc":[110],"Software.":[112],"Sensitivity,":[113],"specificity,":[114],"positive":[115],"predictive":[116,120],"value,":[117],"negative":[119],"value":[121],"were":[122],"calculated":[123],"with":[124,130,159,167,200],"95%":[125],"confidence":[126],"intervals.":[127],"Inter-assay":[128],"agreement":[129,166],"comparator":[133],"assessed":[135],"Cohen\u2019s":[137],"kappa":[138],"(\u03ba)":[139],"coefficient.":[140],"p":[142],"<0.05":[143],"considered":[145],"statistically":[146],"significant.":[147],"Results:":[148],"Among":[149,189],"kits,":[152,192],"Dia.Pro":[153],"Wantai":[155],"demonstrated":[156,210],"optimal":[157],"100%":[160],"sensitivity":[161],"specificity":[163],"perfect":[165],"S.R.L.":[173],"Biogenix":[175,205],"showed":[178,197],"lower":[179],"sensitivities":[180],"92.0":[182],"84.8%,":[184],"respectively,":[185],"despite":[186],"high":[187],"specificity.":[188],"only":[193],"Insight":[195],"assay":[196],"complete":[198],"concordance":[199],"method,":[203],"whereas":[204],"Biotrol":[207],"reduced":[211],"sensitivity.":[212],"Conclusions:":[213],"Significant":[214],"inter-assay":[215],"variability":[216],"exists":[217],"among":[218],"immunoassays.":[223],"Independent":[224],"careful":[227],"selection":[228],"platforms":[231],"are":[232],"essential":[233],"ensure":[235],"reliable":[236],"laboratory":[237],"diagnosis":[238],"acute":[240],"infection.":[242]},"counts_by_year":[],"updated_date":"2026-11-08T12:12:28.789561","created_date":"2026-08-10T00:00:00"}
