First performance report of QIAreach™ Anti-SARS-CoV-2 Total Test, an innovative nanoparticle fluorescence digital detection platform

Stieber, Francis; Howard, Jenny; Rao, Sonia N.; Kawamura, L. Masae; Manissero, Davide; Love, Joanna; Yang, Mei; Uchiyama, Robin; Parsons, Sean P.; Miller, C. J.; Douwes, H; McDonald, Aaron; Fairburn, Luke; Boyle, Jeffrey

doi:10.1016/j.jcv.2020.104681

Cited by 7 publications

(3 citation statements)

References 28 publications

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“…The high level of agreement observed in this study is consistent with the performance reported by the manufacturer [ 27 ], and significantly expands upon the number of clinical specimens used in the previous evaluation. In contrast, the pooled sensitivity calculated in a meta-analysis of other anti-SARS-CoV-2 LFIAs was 66.0% (95% CI: 49.3 to 79.3) [ 9 ].…”

Section: Discussionsupporting

confidence: 89%

Evaluation of SARS-CoV-2 total antibody detection via a lateral flow nanoparticle fluorescence immunoassay

Sibai

Solis

Röltgen

et al. 2021

Journal of Clinical Virology

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Background The coronavirus disease 2019 (COVID-19) endgame may benefit from simple, accurate antibody testing to characterize seroprevalence and immunization coverage. Objectives To evaluate the performance of the lateral flow QIAreach anti-SARS-CoV-2 Total rapid nanoparticle fluorescence immunoassay compared to reference isotype-specific IgG, IgM, and IgA SARS-CoV-2 ELISA using S1 or receptor binding domain (RBD) as antigens. Study design A diagnostic comparison study was carried out using 154 well-characterized heparin plasma samples. Agreement between assays was assessed by overall, positive, and negative percent agreement and Cohen’s kappa coefficient. Results Overall agreement between the QIAreach anti-SARS-CoV-2 Total and any anti-spike domain (S1 or RBD) antibody isotype was 96.0% (95% CI 89.8 to 98.8), the positive percent agreement was 97.6% (95% CI 91.0 to 99.9), the negative percent agreement was 88.2% (95% CI 64.4 to 98.0). The kappa coefficient was 0.86 (95% CI 0.72 to 0.99). Conclusion The QIAreach anti-SARS-CoV-2 Total rapid antibody test provides comparable performance to high-complexity, laboratory-based ELISA.

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Section: Discussionsupporting

confidence: 89%

Evaluation of SARS-CoV-2 total antibody detection via a lateral flow nanoparticle fluorescence immunoassay

Sibai

Solis

Röltgen

et al. 2021

Journal of Clinical Virology

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“…Hu et al found that EDTA-K2 could chelate with colloidal gold, and the chelated colloidal gold was adsorbed on a conjugate release pad, which significantly improved the sensitivity and specificity of the diagnosis (Hu et al, 2021). Stieber et al reported an LFIA detection device using fluorescent nanoparticles as a signal for antibodies against SARS-CoV-2, showing 100% specificity and sensitivity by qualitative detection of the IgM, IgA, and IgG antibodies against SARS-CoV-2 (Stieber et al, 2020). The results of this study need further independent evaluation, but if more researchers can continue to improve the detection accuracy of the LFIA, this method will display greater commercial application value.…”

Section: Lateral Flow Immunoassaymentioning

confidence: 99%

Evaluation and Comparison of Serological Methods for COVID-19 Diagnosis

Gong

Wei

et al. 2021

Front. Mol. Biosci.

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The worldwide pandemic of COVID-19 has become a global public health crisis. Various clinical diagnosis methods have been developed to distinguish COVID-19–infected patients from healthy people. The nucleic acid test is the golden standard for virus detection as it is suitable for early diagnosis. However, due to the low amount of viral nucleic acid in the respiratory tract, the sensitivity of nucleic acid detection is unsatisfactory. As a result, serological screening began to be widely used with the merits of simple procedures, lower cost, and shorter detection time. Serological tests currently include the enzyme-linked immunosorbent assay (ELISA), lateral flow immunoassay (LFIA), and chemiluminescence immunoassay (CLIA). This review describes various serological methods, discusses the performance and diagnostic effects of different methods, and points out the problems and the direction of optimization, to improve the efficiency of clinical diagnosis. These increasingly sophisticated and diverse serological diagnostic technologies will help human beings to control the spread of COVID-19.

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“…Fortunately, the move towards point of care COVID testing is now well underway with the development of both immunoassay and rapid-antigen (RAT) COVID-19 RATs [88]. Field testing of these COVID-19 RATs have correlated results with laboratory-based RT-PCR testing, reaching 99-100% specificity, 22-100% sensitivity [89][90][91][92][93][94][95][96][97] and their epidemiological outcomes can be comparable to that of PCR [43]. With the use of COVID-19 RATs increasing to up to 87% [98] of COVID-19 of tests, it has been proposed that a 100% COVID-19 RAT test regime should be acceptable [43].…”

Section: Rdts For Improved Detection Of Covid-19 In Rural and Remote ...mentioning

confidence: 99%

Lessons for improved COVID-19 surveillance from the scale-up of malaria testing strategies

Kerr

Robinson

Russell

et al. 2022

Malar J

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Effective control of infectious diseases is facilitated by informed decisions that require accurate and timely diagnosis of disease. For malaria, improved access to malaria diagnostics has revolutionized malaria control and elimination programmes. However, for COVID-19, diagnosis currently remains largely centralized and puts many low- and middle-income countries (LMICs) at a disadvantage. Malaria and COVID-19 are infectious diseases that share overlapping symptoms. While the strategic responses to disease control for malaria and COVID-19 are dependent on the disease ecologies of each disease, the fundamental need for accurate and timely testing remains paramount to inform accurate responses. This review highlights how the roll-out of rapid diagnostic tests has been fundamental in the fight against malaria, primarily within the Asia Pacific and along the Greater Mekong Subregion. By learning from the successful elements of malaria control programmes, it is clear that improving access to point-of-care testing strategies for COVID-19 will provide a suitable framework for COVID-19 diagnosis in not only the Asia Pacific, but all malarious countries. In malaria-endemic countries, an integrated approach to point-of-care testing for COVID-19 and malaria would provide bi-directional benefits for COVID-19 and malaria control, particularly due to their paralleled likeness of symptoms, infection control strategies and at-risk individuals. This is especially important, as previous disease pandemics have disrupted malaria control infrastructure, resulting in malaria re-emergence and halting elimination progress. Understanding and combining strategies may help to both limit disruptions to malaria control and support COVID-19 control.

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First performance report of QIAreach™ Anti-SARS-CoV-2 Total Test, an innovative nanoparticle fluorescence digital detection platform

Cited by 7 publications

References 28 publications

Evaluation of SARS-CoV-2 total antibody detection via a lateral flow nanoparticle fluorescence immunoassay

Evaluation of SARS-CoV-2 total antibody detection via a lateral flow nanoparticle fluorescence immunoassay

Evaluation and Comparison of Serological Methods for COVID-19 Diagnosis

Lessons for improved COVID-19 surveillance from the scale-up of malaria testing strategies

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