The Protection Level of S-RBD SARS-CoV-2 Immunoglobulin G Antibodies Using the Chemiluminescent Immunoassay Compared to the Surrogate Virus Neutralization Test MethodArticle Published on 2024-08-142024-09-05 Journal: Diagnostics [Category] update2024, [키워드] antibody protective CLIA IgG SARS-CoV-2 S-RBD sVNT [DOI] 10.3390/diagnostics14161776 PMC 바로가기 [Article Type] Article
FDA’s proposed rule for the regulation of laboratory-developed testsCommentary Published on 2024-02-112024-09-05 Journal: Journal of Clinical Microbiology [Category] update2024, [키워드] CLIA enforcement discretion in vitro diagnostics [DOI] 10.1128/jcm.01488-23 PMC 바로가기 [Article Type] Commentary
Effect of storage temperatures simulating transport conditions of nasopharyngeal swabs on the results of a chemiluminescence immunoassay (CLIA) to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antigenOriginal Research Article Published on 2023-05-062024-09-05 Journal: Indian journal of medical microbiology [Category] update2024, [키워드] CLIA SARS-CoV-2 antigen Storage temperature Transport [DOI] 10.1016/j.ijmmb.2023.100379 PMC 바로가기 [Article Type] Original Research Article
A review post-vaccination SARS-CoV-2 serological test: Method and antibody titer responseArticle Published on 2022-12-012022-11-15 Journal: Analytical biochemistry [Category] COVID19(2023년), SARS, 진단, [키워드] Antibody titer chemiluminescent immunoassay CLIA CMIA Convalescent plasma therapy Coronavirus disease 2019 COVID-19 Efficacy effort ELISA human donor identify immune response Immune titer immunoassay Lateral LFIA pandemic plaque PRNT reactive SARS-CoV-2 serological serological test Serologist Serologist method serology test Test Vaccine Vaccines [DOI] 10.1016/j.ab.2022.114902 PMC 바로가기
Safety and immunogenicity of inactivated COVID-19 vaccination in adult rheumatic patients in South China: a prospective studyArticle Published on 2022-11-302022-11-15 Journal: Human vaccines & immunotherapeutics [Category] COVID19(2023년), SARS, 진단, 치료기술, [키워드] acute respiratory syndrome antibodies antibody Blood C-reactive protein carried Cell China CLIA Coronavirus-2 COVID-19 COVID-19 vaccination COVID-19 vaccine decrease described detect distribution dose effective Effectiveness healthy control high-risk population ICV IgG immunization immunoassay immunogenicity immunosuppressive agent inactivated Inactivated vaccine Infection inoculated Logistic regression analysis magnitude methotrexate parameter Patient patients patients treated positive response Prednisolone Prospective Study Protective antibody receiving recruited response to vaccination rheumatic disease Safe Safety SARS-CoV-2 serious adverse reaction South [DOI] 10.1080/21645515.2022.2090176 PMC 바로가기
Evaluation of five immunoassays and one lateral flow immunochromatography for anti-SARS-CoV-2 antibodies detectionArticle Published on 2022-11-012022-11-15 Journal: Enfermedades infecciosas y microbiologia clinica ( [Category] SARS, 진단, 치료기술, [키워드] addition anti-SARS-CoV-2 anti-SARS-CoV-2 antibodies anti-SARS-CoV-2 antibody approach caused CLIA CLIA assays Clinical practice complementary coronavirus SARS-CoV-2 COVID-19 COVID-19 patient criteria diagnostic ELISA English evaluated FIVE greater healthcare worker healthy IgG IgM IgM antibody immunoassay immunochromatographic test immunochromatography Inmunocromatografía involved lateral flow Pandemia pandemic para performed Rapid test ROC ROC curves RT-PCR SARS-CoV-2 SARS-CoV-2 coronavirus sensitivity serología serological serology serum sample Sin Spanish specificity Support Vaccine [DOI] 10.1016/j.eimce.2020.12.007 PMC 바로가기
Evaluation of qualitative and semi-quantitative cut offs for rapid diagnostic lateral flow test in relation to serology for the detection of SARS-CoV-2 antibodies: findings of a prospective studyArticle Published on 2022-10-312022-11-15 Journal: BMC Infectious Diseases [Category] COVID19(2023년), SARS, 진단, 치료기술, [키워드] 95% CI Accuracy acute respiratory syndrome Analysis antibodies antibody Antibody detection assessments Blood capillary blood chemiluminescent immunoassay CLIA coronavirus coronavirus disease COVID-19 COVID-19 disease cut off cut-off Diagnosis diagnosis of COVID-19 diagnostic Efficacy ELISA evaluate facilitate gold standard identify IgM and IgG immunochromatographic assay information intensity Italy Laboratory Lateral lateral flow lateral flow immunoassay Lateral flow test measure NAAT Non-invasive nucleic acid amplification Patient patients performed POC positive Prospective Study provided Quantitative Rapid Rapid diagnostic test RDT SARS-CoV-2 SARS-CoV-2 antibody semi-quantitative sensitivity serological test serology Severity of disease specificity symptom onset Test the timing venous whole sample [DOI] 10.1186/s12879-022-07786-5 PMC 바로가기
Immune Response after the Fourth Dose of SARS-CoV-2 mRNA Vaccine Compared to Natural Infection in Three Doses’ Vaccinated Solid Organ Transplant RecipientsArticle Published on 2022-10-192022-11-15 Journal: Viruses [Category] COVID19(2023년), SARS, 변종, 진단, [키워드] administration analyzed booster booster dose booster doses Breakthrough infection cellular response CLIA Cohort COVID-19 dose Efficacy ELISA ELISpot assay fourth dose General population humoral IgA IgA level IgG immune immune response IMPROVE in both group Infection mRNA mRNA vaccine natural natural infection new SARS-CoV-2 no difference Organ transplant Patient positive recipient recipients repeated response SARS-CoV-2 SARS-COV-2 infection secretion serum IgG severe COVID-19 significant increase significantly increased Solid solid organ transplant Solid organ transplant recipients Still T cell T-cell T-cell Response Transplant vaccination Vaccine vaccine-induced immune response variants of concern [DOI] 10.3390/v14102299 PMC 바로가기
Buildout and integration of an automated high-throughput CLIA laboratory for SARS-CoV-2 testing on a large urban campusArticle Published on 2022-10-012022-11-15 Journal: Slas Technology [Category] COVID19(2023년), SARS, 치료기술, [키워드] addition automated Boston changed CLIA clinical clinical testing costly COVID-19 COVID-19 testing CTL equipment increase in Laboratory lifted mitigate Outbreaks pandemic performed Personal protective equipment Precaution protocol reverse transcription PCR RT-qPCR Safe SARS-CoV-2 SARS-COV-2 infection SARS-CoV-2 PCR test SARS-CoV-2 testing Testing The United States university Wuhan, China [DOI] 10.1016/j.slast.2022.06.003 PMC 바로가기
A How to Guide: Clinical Population Test Development and Authorization of MALDI-ToF Mass Spectrometry-Based Screening Tests for Viral InfectionsArticle Published on 2022-09-032022-11-15 Journal: Viruses [Category] 치료기술, [키워드] applied Applying Asymptomatic asymptomatic screening authorization Bacteria Bacterial CLIA CLIA-LDT clinical clinical process clinical testing COVID-19 criteria detection development diagnostic fungi Infection Laboratory limits MALDI-TOF MS mass MS test overcome pathogenic Population Population screening Proteins regulatory authority SAR-CoV-2 SARS-CoV-2 Screening Systems biology Test viral infection viral infections Viral protein virus viruses [DOI] 10.3390/v14091958 PMC 바로가기