scholarly journals Immediate determination of ACPA and rheumatoid factor - a novel point of care test for detection of anti-MCV antibodies and rheumatoid factor using a lateral-flow immunoassay

2010 ◽  
Vol 12 (3) ◽  
pp. R120 ◽  
Author(s):  
Franziska Renger ◽  
Holger Bang ◽  
Eugen Feist ◽  
Gert Fredenhagen ◽  
Alexander Natusch ◽  
...  
2020 ◽  
Vol 58 (9) ◽  
Author(s):  
Katharina Ziegler ◽  
Anca Rath ◽  
Christoph Schoerner ◽  
Renate Meyer ◽  
Thomas Bertsch ◽  
...  

ABSTRACT Diagnosis of Lyme neuroborreliosis (LNB) is challenging, as long as Borrelia-specific intrathecal antibodies are not yet detectable. The chemokine CXCL13 is elevated in the cerebrospinal fluid (CSF) of LNB patients. Here, we compared the performances of the Euroimmun CXCL13 enzyme-linked immunosorbent assay (CXCL13 ELISA) and the ReaScan CXCL13 lateral flow immunoassay (CXCL13 LFA), a rapid point-of-care test, to support the diagnosis of LNB. In a dual-center case-control study, CSF samples from 90 patients (34 with definite LNB, 10 with possible LNB, and 46 with other central nervous system [CNS] diseases [non-LNB group]) were analyzed with the CXCL13 ELISA and the CXCL13 LFA. Classification of patients followed the European Federation of Neurological Societies (EFNS) guidelines on LNB. The CXCL13 ELISA detected elevated CXCL13 levels in all patients with definite LNB (median, 1,409 pg/ml) compared to the non-LNB controls (median, 20.7 pg/ml; P < 0.0001), with a sensitivity of 100% and a specificity of 84.8% (cutoff value, 78.6 pg/ml; area under the receiver operating characteristic [ROC] curve, 0.93). Similarly, the CXCL13 LFA yielded elevated CXCL13 levels in 31 patients with definite LNB (median arbitrary value, 223.5) compared to the non-LNB control patients (median arbitrary value, 0; P < 0.0001) and had a sensitivity and specificity of 91.2% and 93.5%, respectively (cutoff arbitrary value, 22.5; area under the ROC curve, 0.94). The correlation between the CXCL13 levels obtained by ELISA and LFA was strong (Spearman correlation coefficient r = 0.89; P < 0.0001). The CXCL13 ELISA and the CXCL13 LFA are comparable diagnostic tools for the detection of CXCL13 in the CSF of patients with definite LNB. The advantage of the CXCL13 LFA is the shorter time to result.


2014 ◽  
Vol 42 (6) ◽  
pp. 635-645 ◽  
Author(s):  
Yongbin Gu ◽  
Yongliang Yang ◽  
Jing Zhang ◽  
ShengXiang Ge ◽  
Zhanghong Tang ◽  
...  

2011 ◽  
Vol 311-313 ◽  
pp. 436-445 ◽  
Author(s):  
Liang Shi ◽  
Xi Chang Wang ◽  
Yuan Liu ◽  
Ying Lu

In this study, a competitive assay format using superparamagnetic nanoparticle-based lateral flow immunoassay (LFIA) was developed for rapid, quantitative detection of shellfish major allergen tropomyosin (Tm). Sartorius CN140 nitrocellulose membrane and 0.05mg/mL Tm immobilized in the test line (T line) were optimized in order to improve the performance of the LFIA system. Calibration curves for Tm under PBS-T diluents and carp muscle extraction diluents were established. Limit of detection (LOD) for Tm calibrated by carp muscle matrix was 12.4ng/mL with a work range of 0.01 to 20μg/mL. According to magnetic signals change with the time of sample flowing on the strip, the qualitative time of the LFIA was about 10min, while the quantitative time of the LFIA was about 25min. 30 food species were detected separately by the LFIA and Western blot method to evaluate the specificity of the LFIA. Overall relative agreement of the two methods was 96.7% (29/30). Moreover, intra- and inter-assay precisions of the LFIA for Tm detection were <10.20% and <12.34%, respectively. The average recovery range in different food matrices was 80.3~111.8%, within a reasonable range. Our data confirmed that the superparamagnetic nanoparticle-based LFIA method developed in this study is rapid, simple, high specificity and capable of quantitative test. Consequently, the LFIA has the potential application in the field of point-of-care test of shellfish major allergen Tm.


2021 ◽  
Vol 334 ◽  
pp. 129673
Author(s):  
Wanghong He ◽  
Minli You ◽  
Zedong Li ◽  
Lei Cao ◽  
Feng Xu ◽  
...  

Author(s):  
Fadi Haddad ◽  
Christopher C Lamb ◽  
Ravina Kullar ◽  
George Sakoulas

Background: Covid-19 remains a pandemic with multiple challenges to confirm patient infectivity: lack of sufficient tests, accurate results, validated quality, and timeliness of results. We hypothesize that a rapid 15-minute Point-Of-Care serological test to evaluate past infection complements diagnostic testing for Covid-19 and significantly enhances testing availability. Method: A three arm observational study at Sharp Healthcare, San Diego, California was conducted using the Clungene® lateral flow immunoassay (LFI) and compared with the Cobas® Roche RT PCR results. Arm 1: Thirty-five (35) subjects with confirmed Covid-19 using RT-PCR were tested twice: prior to 14 days following symptom onset and once between 12 and 70 days. Arm 2: Thirty (30) subjects with confirmed Covid-19 using RT-PCR were tested 12-70 days post symptom onset. Arm 3: Thirty (30) subjects with a negative RT-PCR for Covid-19 were tested 1-10 days following the RT-PCR test date. Results: Specificity of confirmed negative Covid-19 by RT-PCR was 100% (95% CI, 88.4%-100.0%); meaning there was 100% negative positive agreement between the RT-PCR and the Clungene® serological test results. Covid-19 subjects tested prior to day 7 symptom onset were antibody negative. In subjects 7-12 days following symptom onset with a confirmed positive Covid-19 by RT-PCR, the combined sensitivity of IgM and IgG was 58.6% (95% CI, 38.9%-76.5%). In subjects 13-70 days following symptom onset with a confirmed positive Covid-19 by RT-PCR the combined sensitivity of IgM and IgG was 90.5% (95% CI, 80.4%-96.4%). Conclusion: The Clungene® lateral flow immunoassay (LFI) is a useful tool to confirm individuals with an adaptive immune response to SARS-CoV-2 indicating past infection. Providing Point-Of-Care results within 15 minutes without any laboratory instrumentation or specialized software has an added value of increasing test availability to patients who have been symptomatic for more than one week to confirm past infection. Performance characteristics are optimal after 13 days with a sensitivity and specificity of 90% and 100%, respectively.


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