scholarly journals Expanding access to SARS-CoV-2 IgG and IgM serologic testing using fingerstick whole blood, plasma, and rapid lateral flow assays

2021 ◽  
Author(s):  
Mark Anderson ◽  
Vera Holzmayer ◽  
Ana Vallari ◽  
Russell Taylor ◽  
James Moy ◽  
...  
Keyword(s):  
Whole Blood ◽  
Point Of Care ◽  
Lateral Flow ◽  
Signal Recovery ◽  
Sample Collection ◽  
Serologic Testing ◽  
Resource Limited ◽  
High Concordance ◽  
Serology Testing ◽  
Venous Plasma

AbstractSerologic testing for SARS-CoV-2 antibodies can be used to confirm diagnosis, estimate seroprevalence, screen convalescent plasma donors, and assess vaccine efficacy. Several logistical and infrastructure challenges limit access to SARS-CoV-2 serologic testing. Dried blood spot (DBS) samples have been used for serology testing of various diseases in resource-limited settings. We examined the use of DBS samples and capillary blood (fingerstick) plasma collected in Microtainer tubes for SARS-CoV-2 testing with the automated Abbott ARCHITECT™ SARS-CoV-2 IgG (List 6R86) and IgM assays and use of venous whole blood with a prototype PANBIO™ rapid point-of-care lateral flow SARS-CoV-2 IgG assay. The ARCHITECT™ SARS-CoV-2 IgG assay was initially optimized for use with DBS, venous and capillary plasma, and venous whole blood collected from patients with symptoms and PCR-confirmed COVID-19 and negative asymptomatic controls. Assay linearity and reproducibility was confirmed with 3 contrived DBS samples, with sample stability and signal recovery after 14 days at room temperature. ARCHITECT™ SARS-CoV-2 IgG and IgM assay results showed high concordance between fingerstick DBS and venous DBS samples, and between fingerstick DBS and venous whole blood samples (n=61). Discordant results were seen in 3 participants (2 IgG, 1 IgM) who were in the process of seroreversion at the time of sample collection and had results near the assay cutoff. Use of fingerstick plasma collected in Microtainer tubes (n=109) showed 100% concordant results (R2=0.997) with matched patient venous plasma on the ARCHITECT™ SARS-CoV-2 IgG assay. High concordance of assay results (92.9% positive, 100% negative) was also observed for the PANBIO™ SARS-CoV-2 IgG assay compared to the ARCHITECT™ SARS-CoV-2 IgG assay run with matched venous plasma (n=61). Fingerstick DBS and plasma samples are easy and inexpensive to collect and, along with the use of rapid point-of-care testing platforms, will expand access to SARS-CoV-2 serology testing, particularly in resource-limited areas.

scholarly journals Direct comparison of venipuncture serum draws versus whole blood finger-stick specimens by anti-COVID-19 IgG/IgM rapid lateral flow immunoassay and ELISA.

2021 ◽  
Author(s):  
Irfan Baig ◽  
Christian Tagwerker ◽  
Eric J. Brunson ◽  
Kristine Mundo ◽  
Davan Dutra-Smith ◽  
...  
Keyword(s):  
Whole Blood ◽  
Point Of Care ◽  
Lateral Flow ◽  
Lateral Flow Immunoassay ◽  
Test Results ◽  
Sample Collection ◽  
Igm Antibodies ◽  
Specificity And Sensitivity ◽  
Qualitative Test ◽  
Finger Stick

During the COVID-19 pandemic, manufacturers have developed several diagnostic test kits that include lateral flow immunoassays (LFIA) also known as rapid cassette testing. Rapid cassette testing provides qualitative test results indicating the presence or absence of IgG and IgM antibodies to determine COVID-19 (SARS-CoV-2) infection among individuals. Venipuncture blood draws have been the traditional and widely proposed sample collection method but is costly and not applicable to point-of-care testing (POC) and in remote settings. Whole blood finger-stick blood collections traditionally used by diabetics for glucose level testing is an ideal scenario, but raises concerns regarding the outcome of test results in regards to specificity and sensitivity. In this study we directly compare simultaneous collections of venipuncture serum (SST) blood draws and whole blood finger-sticks (n = 75) to detect human Anti-COVID-19 IgG and IgM antibodies using an EUA-approved lateral flow immunoassay, showing equal to enhanced performance characteristics for this specimen type.

scholarly journals Microneedle-based skin patch for blood-free rapid diagnostic testing

2020 ◽  
Vol 6 (1) ◽  
Author(s):  
Xue Jiang ◽  
Peter B. Lillehoj
Keyword(s):  
Interstitial Fluid ◽  
Point Of Care ◽  
Diagnostic Testing ◽  
Protein Detection ◽  
Lateral Flow ◽  
Lateral Flow Assay ◽  
Detection Sensitivity ◽  
Sample Collection ◽  
Protein Biomarkers ◽  
Skin Patch

Abstract Rapid diagnostic tests are one of the most commonly used tests to detect and screen for infectious diseases in the developing world. While these tests are simple, inexpensive, and readily available, they rely on finger-prick blood sampling, which requires trained medical personnel, poses risks of infection, and can complicate cooperation in young children, asymptomatic individuals, and communities with blood taboos. Here, we report a novel microneedle-based skin patch for the rapid detection of protein biomarkers in dermal interstitial fluid. Sample collection is facilitated by a hydrophilic hollow microneedle array that autonomously extracts and transports interstitial fluid to an antibody-based lateral flow test strip via surface tension for colorimetric antigen detection. We employ a simple gold enhancement treatment to enhance the detection sensitivity of this colloidal gold-based lateral flow assay and elucidate the underlying mechanism of this enhancement mechanism through experimental investigation. For proof-of-concept, this device was used to detect Plasmodium falciparum histidine-rich protein 2, a biomarker for malaria infection, which could be detected at concentrations as low as 8 ng/mL. Each test can be completed in <20 min and requires no equipment. To the best of our knowledge, this work is the first demonstration of a microneedle-based lateral flow assay for rapid protein detection in dermal interstitial fluid. In addition to its simplicity, minimally invasive nature, and low cost, this diagnostic device can be readily adapted to detect other protein biomarkers in interstitial fluid, making it a promising tool for point-of-care testing.

scholarly journals Expanding access to SARS-CoV-2 IgG and IgM serologic testing using fingerstick whole blood, plasma, and rapid lateral flow assays

2021 ◽  
pp. 104855
Author(s):  
Mark Anderson ◽  
Vera Holzmayer ◽  
Ana Vallari ◽  
Russell Taylor ◽  
James Moy ◽  
...  
Keyword(s):  
Blood Plasma ◽  
Whole Blood ◽  
Lateral Flow ◽  
Serologic Testing ◽  
Lateral Flow Assays

scholarly journals Engineering luminescent biosensors for point-of-care SARS-CoV-2 antibody detection

2020 ◽  
Author(s):  
Susanna K. Elledge ◽  
Xin X. Zhou ◽  
James R. Byrnes ◽  
Alexander J. Martinko ◽  
Irene Lui ◽  
...  
Keyword(s):  
Whole Blood ◽  
Point Of Care ◽  
Low Cost ◽  
Lateral Flow ◽  
Antibody Detection ◽  
Lateral Flow Assays ◽  
Quantitative Results ◽  
Development And Validation ◽  
Antibody Tests ◽  
Split Luciferase

Current serology tests for SARS-CoV-2 antibodies mainly take the form of enzyme-linked immunosorbent assays or lateral flow assays, with the former being laborious and the latter being expensive and often lacking sufficient sensitivity and scalability. Here we present the development and validation of a rapid, low-cost solution-based assay to detect antibodies in serum, plasma, whole blood, and saliva, using rationally designed split luciferase antibody biosensors (spLUC). This new assay, which generates quantitative results in as short as 5 minutes, substantially reduces the complexity and improves the scalability of COVID-19 antibody tests for point-of-care and broad population testing.

scholarly journals Point-of-Need Disposable ELISA System for COVID-19 Serology Testing

2021 ◽  
Author(s):  
Cody Carrell ◽  
Jeremy Link ◽  
Ilhoon Jang ◽  
James Terry ◽  
Michael Scherman ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Point Of Care ◽  
Lateral Flow ◽  
World Health ◽  
Clinical Samples ◽  
Enzyme Linked Immunosorbent Assay ◽  
Elisa System ◽  
Health Organization ◽  
Care Technology ◽  
Serology Testing

A disposable enzyme-linked immunosorbent assay (dELISA) device for ate-home or doctor’s office use was developed to detect SARS-CoV-2 antibodies. Serology testing for SARS-CoV-2 antibodies is currently run using well-plate ELISAs in centralized laboratories. However, the scale of serology testing needed for epidemiological and clinical screening studies will overwhelm existing clinical laboratory resources. Instead, a point-of-need device that can be used at home or in doctor’s offices for COVID-19 serology testing must be developed and is one of four target products prioritized by the World Health Organization. Lateral flow assays are common and easy to use, but lack the sensitivity needed to reliably detect SARS-CoV-2 antibodies in clinical samples. This work describes a disposable ELISA device that is as simple to use as a lateral flow assay, but as sensitive as a well-plate ELISA. The device utilizes capillary-driven flow channels made of transparency films and double-sided adhesive combined with paper pumps to drive flow. The geometry of the channels and storage pads enables automated sequential washing and reagent addition steps with two simple end-user steps. An enzyme label is used to produce a colorimetric signal instead of a nanoparticle label in order to amplify signal and increase sensitivity, while the integrated washing steps decrease false positives and increase reproducibility. Naked-eye detection can be used for qualitative results or a smartphone camera for quantitative analysis. The device can detect antibodies at 2.8 ng/mL from whole blood, which was very close the concentration of detectable target in a well-plate ELISA (1.2 ng/mL). In this study the dELISA system was used to detect SARS-CoV-2 antibodies, but we believe that the device represents a fundamental step forward in point-of-care technology that will enable sensitive detection of many other analytes outside of a centralized laboratory.

scholarly journals A point-of-care lateral flow assay for neutralising antibodies against SARS-CoV-2

2021 ◽  
Author(s):  
Thomas S. Fulford ◽  
Huy Van ◽  
Nicholas A. Gherardin ◽  
Shuning Zheng ◽  
Marcin Ciula ◽  
...  
Keyword(s):  
Point Of Care ◽  
Venous Blood ◽  
Lateral Flow ◽  
Virus Infectivity ◽  
Resource Limited Settings ◽  
Neutralising Antibodies ◽  
Active Immunisation ◽  
Resource Limited ◽  
Laboratory Facilities ◽  
Strong Correlate

As vaccines against SARS-CoV-2 are now being rolled out, a better understanding of immunity to the virus; whether through infection, or passive or active immunisation, and the durability of this protection is required. This will benefit from the ability to measure SARS-CoV-2 immunity, ideally with rapid turnaround and without the need for laboratory-based testing. Current rapid point-of-care (POC) tests measure antibodies (Ab) against the SARS-CoV-2 virus, however, these tests provide no information on whether the antibodies can neutralise virus infectivity and are potentially protective, especially against newly emerging variants of the virus. Neutralising Antibodies (NAb) are emerging as a strong correlate of protection, but most current NAb assays require many hours or days, samples of venous blood, and access to laboratory facilities, which is especially problematic in resource-limited settings. We have developed a lateral flow POC test that can measure levels of RBD-ACE2 neutralising antibodies from whole blood, with a result that can be determined by eye (semi-quantitative) or on a small instrument (quantitative), and results show high correlation with microneutralisation assays. This assay also provides a measure of total anti-RBD antibody, thereby providing evidence of exposure to SARS-CoV-2, regardless of whether NAb are present in the sample. By testing samples from immunised macaques, we demonstrate that this test is equally applicable for use with animal samples, and we show that this assay is readily adaptable to test for immunity to newly emerging SARS-CoV-2 variants. Accordingly, the COVID-19 NAb-testTM test described here can provide a rapid readout of immunity to SARS-CoV-2 at the point of care.

A microfluidic-integrated lateral flow recombinase polymerase amplification (MI-IF-RPA) assay for rapid COVID-19 detection

Lab on a Chip ◽  
2021 ◽  
Author(s):  
Dan Liu ◽  
Haicong Shen ◽  
Yuqian Zhang ◽  
Danyu Shen ◽  
Mingyang Zhu ◽  
...  
Keyword(s):  
Point Of Care ◽  
Lateral Flow ◽  
Recombinase Polymerase Amplification ◽  
Point Of Care Testing ◽  
Resource Limited ◽  
Medical Crisis

The COVID-19 pandemic, caused by SARS-CoV-2, currently poses an urgent global medical crisis for which there remains a lack of affordable point-of-care testing (POCT). In particular, resource-limited areas need simple...

scholarly journals Clinical performance of two EUA-approved anti-COVID-19 IgG/IgM rapid lateral flow immunoassays using whole blood finger-sticks

2021 ◽  
Author(s):  
Christian Tagwerker ◽  
Irfan Baig ◽  
Eric Brunson ◽  
Kristine Mundo ◽  
Dava Dutra-Smith ◽  
...  
Keyword(s):  
Blood Plasma ◽  
Whole Blood ◽  
Clinical Performance ◽  
Point Of Care ◽  
Cost Effective ◽  
Lateral Flow ◽  
Simultaneous Application ◽  
Igm Elisa ◽  
Elisa Testing ◽  
Finger Stick

Serological, or antibody, tests detect immunoglobulins produced by the hosts plasma B cells following exposure to foreign antigens. Venipuncture blood draws to collect human venous whole blood, plasma from anticoagulated blood (Li+ heparin, K2EDTA and sodium citrate), or serum are commonly utilized and require refrigerated temperatures during transport to the testing facility. Subsequent laboratory testing by enzyme-linked immunosorbent assays (ELISA) or chemiluminescence immunoassays (CLIA) can take an additional 2-5 hours. In the context of the COVID-19 pandemic, rapid diagnostic tests (RDT) to be used in point-of-care (POC) and remote settings have become essential during mandatory quarantine and isolation periods. RDTs allowed for more cost-effective testing using less collection materials with an immediate (5-10 minutes) test result. However, the majority of emerging RDTs receiving Emergency Use Authorization (EUA) approval by the Food and Drug Administration (FDA) for qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 were only approved for use in human venous whole blood, plasma or serum. In this study we summarize performance characteristics of one RDT (COVID-19 IgG/IgM lateral flow immunoassay rapid cassette) to another by simultaneous application of whole blood finger-stick specimens (n = 32). The study was performed over 5 different days, with daily quality controls consisting of serum previously verified to be positive or negative by COVID-19 IgG/IgM ELISA testing.

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