Performance of VivaDiag COVID‐19 IgM/IgG Rapid Test is inadequate for diagnosis of COVID‐19 in acute patients referring to emergency room department

Cassaniti, Irene; Novazzi, Federica; Giardina, Federica; Salinaro, Francesco; Sachs, Michele; Perlini, Stefano; Bruno, Raffaele; Mojoli, Francesco; Baldanti, Fausto

doi:10.1002/jmv.25800

Cited by 241 publications

(262 citation statements)

References 5 publications

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“…In the case of non-urgent elective procedures, especially in the case of aesthetic procedures without a curative indication, surgeons have to be aware that even with a solid routine testing protocol in place for all elective patients there is still a window of uncertainty due to test sensitivity and incubations times [27][28][29].…”

Section: Clinical Considerations For Reintegration Of Elective Non-umentioning

confidence: 99%

“…Seroconversion (detectable antibodies) in a patient cohort in Germany with mild COVID-19 symptoms occurred in half of all patients by day 7, and in all by day 14 [84]. An Italian paper showed that serological rapid tests are not useful for diagnosing COVID-19 in the acute setting [29], when the RT-PCR is more useful. Other studies showed that IgM is detectable in samples from 10 to 30 days after SARS-CoV-2 infection, while IgG can be detected from 20 days onward [89].…”

Section: Clinical Relevance Serological Antibody Testsmentioning

confidence: 99%

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Elective, Non-urgent Procedures and Aesthetic Surgery in the Wake of SARS–COVID-19: Considerations Regarding Safety, Feasibility and Impact on Clinical Management

Kaye¹,

Paprottka²,

Escudero³

et al. 2020

Aesth Plast Surg

101

145

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Background The worldwide spread of a novel coronavirus disease has led to a near total stop of nonurgent, elective surgeries across all specialties in most affected countries. In the field of aesthetic surgery, the selfimposed moratorium for all aesthetic surgery procedures recommended by most international scientific societies has been adopted by many surgeons worldwide and resulted in a huge socioeconomic impact for most private practices and clinics. An important question still unanswered in most countries is when and how should elective/aesthetic procedures be scheduled again and what kind of organizational changes are necessary to protect patients and healthcare workers when clinics and practices reopen. Defining manageable, evidence-based protocols for testing, surgical/ procedural risk mitigation and clinical flow management/contamination management will be paramount for the safety of non-urgent surgical procedures. Methods We conducted a MEDLINE/PubMed research for all available publications on COVID-19 and surgery and COVID-19 and anesthesia. Articles and referenced literature describing possible procedural impact factors leading to exacerbation of the clinical evolution of COVID-19positive patients were identified to perform risk stratification for elective surgery. Based on these impact factors, considerations for patient selection, choice of procedural complexity, duration of procedure, type of anesthesia, etc., are discussed in this article and translated into algorithms for surgical/anesthesia risk management and clinical management. Current recommendations and published protocols on contamination control, avoidance of crosscontamination and procedural patient flow are reviewed. A COVID-19 testing guideline protocol for patients planning to undergo elective aesthetic surgery is presented and recommendations are made regarding adaptation of current patient information/informed consent forms and patient health questionnaires. Conclusion The COVID-19 crisis has led to unprecedented challenges in the acute management of the crisis, and the wave only recently seems to flatten out in some countries. The adaptation of surgical and procedural steps for a riskminimizing management of potential COVID-19-positive patients seeking to undergo elective aesthetic procedures in the wake of that wave will present the next big challenge for the aesthetic surgery community. We propose a clinical algorithm to enhance patient safety in elective surgery in the context of COVID-19 and to minimize cross-contamination between healthcare workers and patients. New evidence-based guidelines regarding surgical risk stratification, testing, and clinical flow management/contamination management are proposed. We believe that only the continuous development and broad implementation of guidelines like the ones proposed in this paper will allow an early reintegration of all aesthetic procedures into the scope of surgical care currently performed and to prepare

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Section: Clinical Considerations For Reintegration Of Elective Non-umentioning

confidence: 99%

Section: Clinical Relevance Serological Antibody Testsmentioning

confidence: 99%

Elective, Non-urgent Procedures and Aesthetic Surgery in the Wake of SARS–COVID-19: Considerations Regarding Safety, Feasibility and Impact on Clinical Management

Kaye¹,

Paprottka²,

Escudero³

et al. 2020

Aesth Plast Surg

101

145

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“…A point-of-care lateral flow immunoassay (LFIA) test product (VivaDiag COVID-19 IgM/IgG Rapid Test) was designed to detect IgM and IgG in blood samples of COVID-19 patients in 15 min [75]. However, the sensitivity of the VivaDiag COVID-19 IgM/IgG Rapid Test was only 18.4% in blood samples of acute COVID-19 patients from the emergency department [76], suggesting that serological tests require more research before being deemed suitable for routine diagnosis. Additionally, the seroconversion rate for total antibodies, IgM, and IgG were shown to be 93.1%, 82.7%, and 64.7%, respectively, in hospitalised COVID-19 patients, peaking 7-14 days after symptom onset [77].…”

Section: Salivary Immunity Monitoring For Covid-19mentioning

confidence: 99%

Saliva—Friend and Foe in the COVID-19 Outbreak

Han

Ivanovski

2020

Diagnostics

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The coronavirus disease 2019 outbreak, caused by the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has become a global ongoing pandemic. Timely, accurate and non-invasive SARS-CoV-2 detection in both symptomatic and asymptomatic patients, as well as determination of their immune status, will facilitate effective large-scale pandemic control measures to prevent the spread of COVID-19. Saliva is a biofluid whose anatomical source and location is of particularly strategic relevance to COVID-19 transmission and monitoring. This review focuses on the role of saliva as both a foe (a common mode of viral transmission via salivary droplets and potentially aerosols) and a friend (as a non-invasive diagnostic tool for viral detection and immune status surveillance) in combating COVID-19.

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“…More than 200 different assays have been proposed so far but almost all have poor regulatory status and lack clinical and analytical performance review. 8 In fact the speed with which they are released in the market and the versatility of immunoassays such as source of antigen and secondary antibody conjugate, make them poorly evaluated tests. Given that during the outbreak test validation is not a priority and given that nonlaboratory specialists are allowed to handle these tests because of limited staff resources has meant that unregulated testing has spread widely.…”

mentioning

confidence: 99%

Diagnostic accuracy of an automated chemiluminescent immunoassay for anti‐SARS‐CoV‐2 IgM and IgG antibodies: an Italian experience

Infantino

Grossi

Lari

et al. 2020

Journal of Medical Virology

146

124

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A pandemic of coronavirus disease 2019 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been spreading throughout the world. Though molecular diagnostic tests are the gold standard for COVID-19, serological testing is emerging as a potential surveillance tool, in addition to its complementary role in COVID-19 diagnostics. Indubitably quantitative serological testing provides greater advantages than qualitative tests but today there is still little known about serological diagnostics and what the most appropriate role quantitative tests might play. Sixty-one COVID-19 patients and 64 patients from a control group were tested by iFlash1800 CLIA analyzer for anti-SARS CoV-2 antibodies IgM and IgG. All COVID-19 patients were hospitalized in San Giovanni di Dio Hospital (Florence, Italy) and had a positive oro/nasopharyngeal swab reversetranscription polymerase chain reaction result. The highest sensitivity with a very good specificity performance was reached at a cutoff value of 10.0 AU/mL for IgM and of 7.1 for IgG antibodies, hence near to the manufacturer's cutoff values of 10 AU/mL for both isotypes. The receiver operating characteristic curves showed area under the curve values of 0.918 and 0.980 for anti-SARS CoV-2 antibodies IgM and IgG, respectively. iFlash1800 CLIA analyzer has shown highly accurate results for the anti-SARS-CoV-2 antibodies profile and can be considered an excellent tool for COVID-19 diagnostics.

show abstract

Performance of VivaDiag COVID‐19 IgM/IgG Rapid Test is inadequate for diagnosis of COVID‐19 in acute patients referring to emergency room department

Cited by 241 publications

References 5 publications

Elective, Non-urgent Procedures and Aesthetic Surgery in the Wake of SARS–COVID-19: Considerations Regarding Safety, Feasibility and Impact on Clinical Management

Elective, Non-urgent Procedures and Aesthetic Surgery in the Wake of SARS–COVID-19: Considerations Regarding Safety, Feasibility and Impact on Clinical Management

Saliva—Friend and Foe in the COVID-19 Outbreak

Diagnostic accuracy of an automated chemiluminescent immunoassay for anti‐SARS‐CoV‐2 IgM and IgG antibodies: an Italian experience

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