The SARS-CoV-2 pandemic has created an unprecedented need for rapid diagnostic testing
to enable the efficient treatment and mitigation of COVID-19. The primary diagnostic
tool currently employed is reverse transcription polymerase chain reaction (RT-PCR),
which can have good sensitivity and excellent specificity. Unfortunately, implementation
costs and logistical problems with reagents during the global SARS-CoV-2 pandemic have
hindered its universal on demand adoption. Lateral flow assays (LFAs) represent a class
of diagnostic that, if sufficiently clinically sensitive, may fill many of the gaps in
the current RT-PCR testing regime, especially in low- and middle-income countries
(LMICs). To date, many serology LFAs have been developed, though none meet the
performance requirements necessary for diagnostic use cases, primarily due to the
relatively long delay between infection and seroconversion. However, on the basis of
previously reported results from SARS-CoV-1, antigen-based SARS-CoV-2 assays may have
significantly better clinical sensitivity than serology assays. To date, only a very
small number of antigen-detecting LFAs have been developed. Development of a half-strip
LFA is a useful first step in the development of any LFA format. In this work, we
present a half-strip LFA using commercially available antibodies for the detection of
SARS-CoV-2. We have tested this LFA in buffer and measured an LOD of 0.65 ng/mL (95% CI
of 0.53 to 0.77 ng/mL) ng/mL with recombinant antigen using an optical reader with
sensitivity equivalent to a visual read. Further development, including evaluating the
appropriate sample matrix, will be required for this assay approach to be made useful in
a point of care setting, though this half-strip LFA may serve as a useful starting point
for others developing similar tests.
Escherichia coli that express Dr fimbriae and related adhesins recognize the common receptor decay accelerating factor. E. coli strains that express adhesins of the Dr family were postulated to be associated with cystitis (30-50%), pregnancy-associated pyelonephritis (30%), and chronic diarrhea (50%). In this study, we investigated the hypothesis that E. coli
Inexpensive, simple, rapid diagnostics are necessary for efficient detection, treatment, and mitigation of COVID-19. Assays for SARS-CoV2 using reverse transcription polymerase chain reaction (RT-PCR) offer good sensitivity and excellent specificity, but are expensive, slowed by transport to centralized testing laboratories, and often unavailable. Antigen-based assays are inexpensive and can be rapidly mass-produced and deployed at point-of-care, with lateral flow assays (LFAs) being the most common format. While various manufacturers have produced commercially available SARS-Cov2 antigen LFAs, access to validated tests remains difficult or cost prohibitive in low-and middle-income countries. Herein, we present a visually read open-access LFA (OA-LFA) using commercially-available antibodies and materials for the detection of SARS-CoV-2. The LFA yielded a Limit of Detection (LOD) of 4 TCID50/swab of gamma irradiated SARS-CoV-2 virus, meeting the acceptable analytical sensitivity outlined by in World Health Organization target product profile. The open-source architecture presented in this manuscript provides a template for manufacturers around the globe to rapidly design a SARS-CoV2 antigen test.
Current quantification methods of Escherichia coli (E. coli) contamination in water samples involve long incubation, laboratory equipment and facilities, or complex processes that require specialized training for accurate operation and...
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