Alltest rapid lateral flow immunoassays is reliable in diagnosing SARS-CoV-2 infection from 14 days after symptom onset: A prospective single-center study

Pérez-García, Felipe; Pérez‐Tanoira, Ramón; Romanyk, Juan; Arroyo, Teresa; Gómez-Herruz, Peña; Cuadros-González, Juan

doi:10.1016/j.jcv.2020.104473

Cited by 41 publications

(42 citation statements)

References 23 publications

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“…Nevertheless, as RDTs are meant to be used without centrifugation, the implication of this observation is merely technical. Our results contrast with current RDT data available in the literature [ 2 , 3 , 4 , 5 , 15 , 16 ]. Indeed, Cassaniti and colleagues tested a RDT in the specific setting of acute diagnosis in the emergency department and found very low performance, thus suggesting that RDTs should be avoided in this particular acute clinical setting with potentially very short DPDs.…”

Section: Discussioncontrasting

confidence: 99%

Head-to-Head Accuracy Comparison of Three Commercial COVID-19 IgM/IgG Serology Rapid Tests

Andrey

Cohen

Meyer

et al. 2020

JCM

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Background: Comparative data of SARS-CoV-2 IgM/IgG serology rapid diagnostic tests (RDTs) is scarce. We thus performed a head-to-head comparison of three RDTs. Methods: In this unmatched case-control study, blood samples from 41 RT-PCR-confirmed COVID-19 cases and 50 negative controls were studied. The diagnostic accuracy of three commercially available COVID-19 RDTs: NTBIO (RDT-A), Orient-Gene (RDT-B), and MEDsan (RDT-C), against both a recombinant spike-expressing immunofluorescence assay (rIFA) and Euroimmun IgG ELISA, was assessed. RDT results concordant with the reference methods, and between whole blood and plasma, were established by the Kendall coefficient. Results: COVID-19 cases’ median time from RT-PCR to serology was 22 days (interquartile range (IQR) 13–31 days). Whole-blood IgG detection with RDT-A, -B, and -C showed 0.93, 0.83, and 0.98 concordance with rIFA. Against rIFA, RDT-A sensitivity (SN) was 92% (95% CI: 78–98) and specificity (SP) 100% (95% CI: 91–100), RDT-B showed 87% SN (95% CI: 72–95) and 98% SP (95% CI: 88–100), and RDT-C 100% SN (95% CI: 88–100) and 98% SP (95% CI: 88–100). Against ELISA, SN and SP were above 90% for all three RDTs. Conclusions: RDT-A and RDT-C displayed IgG detection SN and SP above 90% in whole blood. These RDTs could be considered in the absence of routine diagnostic serology facilities.

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Section: Discussioncontrasting

confidence: 99%

Head-to-Head Accuracy Comparison of Three Commercial COVID-19 IgM/IgG Serology Rapid Tests

Andrey

Cohen

Meyer

et al. 2020

JCM

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“…Recent reviews have shown that nucleic acid-based methods are prone to false negative results because of insufficient viral RNA at the point of detection [ 4 ], and that antibody-based methods have slightly lower sensitivity but higher accuracy compared to molecular assays [ 5 ]. Serological assays have been suggested for the diagnosis of the infection [ 6 ] and combining the two methods is recommended to improve the detection accuracy of COVID-19 [ [4] , [5] ]. Although accurate, laboratory-based assays cannot guarantee the massive case finding so helping curb the epidemic.…”

Section: Introductionmentioning

confidence: 99%

“…As other virus affecting the respiratory traits, also SARS CoV-2 elicits the production of another class of specific immunoglobulins A (IgA) in respiratory specimens and the presence of specific anti-SARS CoV-2 IgA in the blood has also been reported [ [5] , [6] , [7] , [8] , [9] , [10] , [11] ]. Hence, we conceived a novel diagnostic strategy that aimed at targeting the ‘total antibody’ response elicited by SARS CoV-2 infection to enhance sensitivity and, hopefully, expedite diagnosis.…”

Section: Introductionmentioning

confidence: 99%

A multi-target lateral flow immunoassay enabling the specific and sensitive detection of total antibodies to SARS COV-2

Cavalera

Colitti

Rosati

et al. 2021

Talanta

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A rapid test for detecting total immunoglobulins directed towards the nucleocapsid protein (N) of severe acute syndrome coronavirus 2 (SARS CoV-2) was developed, based on a multi-target lateral flow immunoassay comprising two test lines. Both test lines bound to several classes of immunoglobulins (G, M, and A). Specific anti-SARS immunoglobulins were revealed by a colorimetric probe formed by N and gold nanoparticles. Targeting the total antibodies response to infection enabled achieving 100% diagnostic specificity (95.75-100, C.I. 95%, n=85 healthy and with other infections individuals) and 94.6% sensitivity (84.9-98.9, C.I. 95%, n= 62 SARS CoV-2 infected subjects) as early as 7 days post confirmation of positivity. Agreeing results with a reference serological ELISA were achieved, except for the earlier detection capability of the rapid test. Follow up of the three seroconverting patients endorsed the hypothesis of the random rise of the different immunoglobulins and strengthened the ‘total antibodies’ approach for the trustworthy detection of serological response to SARS CoV-2 infection.

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“…Recently, rapid lateral flow assays for IgG and IgM antibodies produced during the COVID-19 epidemic have been developed [ 11 ]. Several reports have shown that COVID-19 IgG/IgM lateral flow immunoassays may be a reliable tool to diagnose SARS-CoV-2 infection from 14 days of onset of symptoms [ 12 , 13 ]. In some countries, rapid diagnostic testing for COVID-19 has been incorporated into the local guidelines for testing asymptomatic contacts of positive cases, at day 14 of home surveillance [ 14 ].…”

Section: Introductionmentioning

confidence: 99%

Capillary whole-blood IgG-IgM COVID-19 self-test as a serological screening tool for SARS-CoV-2 infection adapted to the general public

Tonen‐Wolyec

Dupont²,

Batina‐Agasa

et al. 2020

PLoS ONE

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The practicability of a prototype capillary whole-blood IgG-IgM COVID-19 self-test (Exacto ® COVID-19 self-test, Biosynex Swiss SA, Freiburg, Switzerland) as a serological screening tool for SARS-CoV-2 infection adapted to the general public was evaluated in a cross-sectional, general adult population study performed between April and May 2020 in Strasbourg, France, consisting of face-to-face, paper-based, semi-structured, and self-administrated questionnaires. Practicability was defined as the correct use of the self-test and the correct interpretation of the result. The correct use of self-test was conditioned by the presence of the control band after 15-min of migration. The correct interpretation of the tests was defined by the percent agreement between the tests results read and interpret by the participants compared to the expected results coded by the numbers and verified by trained observers. A total of 167 participants (52.7% female; median age, 35.8 years; 82% with post-graduate level) were enrolled, including 83 and 84 for usability and test results interpretation substudies, respectively. All participants (100%; 95% CI: 95.6–100) correctly used the self-test. However, 12 (14.5%; 95% CI: 8.5–23.6) asked for verbal help. The percent agreement between the tests results read and interpret by the participants compared to the expected results was 98.5% (95% CI: 96.5–99.4). However, misinterpretation occurred in only 2.3% of positive and 1.2% of invalid test results. Finally, all (100%) participants found that performing the COVID-19 self-test was easy; and 98.8% found the interpretation of the self-test results easy. Taken together, these pilot observations demonstrated for the first-time, high practicability and satisfaction of COVID-19 self-testing for serological IgG and IgM immune status, indicating its potential for use by the general public to complete the arsenal of available SARS-CoV-2 serological assays in the urgent context of the COVID-19 epidemic.

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Alltest rapid lateral flow immunoassays is reliable in diagnosing SARS-CoV-2 infection from 14 days after symptom onset: A prospective single-center study

Cited by 41 publications

References 23 publications

Head-to-Head Accuracy Comparison of Three Commercial COVID-19 IgM/IgG Serology Rapid Tests

Head-to-Head Accuracy Comparison of Three Commercial COVID-19 IgM/IgG Serology Rapid Tests

A multi-target lateral flow immunoassay enabling the specific and sensitive detection of total antibodies to SARS COV-2

Capillary whole-blood IgG-IgM COVID-19 self-test as a serological screening tool for SARS-CoV-2 infection adapted to the general public

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