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COVID-19 IgG/IgM Antibody Test

COVID-19 IgG/IgM Antibody Test

COVID-19 IgG/IgM Antibody Test

By Phosphorus

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Overview


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DESCRIPTION
For use to aid detection of antibodies against SARS-CoV-2 virus in individuals who have experienced symptoms of COVID-19.
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PRODUCT ATTRIBUTES
badge_covid-19

COVID-19


badge_pediatric

Pediatric


CATEGORIES

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KEYWORDS

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CLIENTS OVERVIEW
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EHR integration

Integrations:

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EMR Integration & Relevant Hardware:

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EMRs Supported:

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Hardware Compatibility:

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Description

Methodology: The COVID-19 ELISA IgG/IgM Antibody Test is an enzyme-linked immunosorbent assay (ELISA). It was developed to detect the presence of human antibodies targeting the viral Nucleocapsid (N) protein. Specimen and Transport: Serum whole blood via red top venipuncture draw, capillary blood collected using TAP Blood Collection or capillary blood collected using Mitra Microsampling Devices may be used for this test. Capillary devices are self-administrable, eliminating need for specialized training and minimizing risk due to close contact. After collection, the specimen is shipped to Phosphorus using included packaging and envelope at ambient temperature. Turnaround Time: Within 72 hours from date of receipt at the laboratory Performance: Sensitivity: 97.1% Specificity: 98.2% Positive Predictive Value: 97.1% Negative Predictive Value: 98.2% Clinical & Stability Study: Clinical Performance: 146 Samples (62 positives and 84 negatives - confirmed by clinical assessment and qPCR testing by 3rd party EUA approved laboratories). Stability: 10 representative samples were analyzed across 3 collection methods for both IgG and IgM proficiency through simulated temperatures between 22°C and 40°C for up to 72 hours.
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Use cases

Description

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COVID-19 use cases:
For use to aid detection of antibodies against SARS-CoV-2 virus in individuals who have experienced symptoms of COVID-19.
Differentiators

Differentiators vs EHR Functionality:

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Differentiators vs Competitors:

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Company information

Founded in 2016

18.0M total equity funding

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