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COVID-19 RT-qPCR Test

COVID-19 RT-qPCR Test

COVID-19 RT-qPCR Test

By Phosphorus

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Overview


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About

DESCRIPTION
For use to aid detection of active virus and diagnosis of COVID-19 in individuals with associated symptoms, or for those with exposures to individuals with symptoms.
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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 RT-qPCR Test is a real-time reverse transcription polymerase chain reaction (RT-qPCR) test. This test uses two primers and probe sets to detect two regions in the SARS-CoV-2 Nucleocapsid (N) gene (N1 and N2) and one primer and probe set to detect human RNase P (RP) in a clinical sample. Specimen and Transport: Saliva is collected using the Oragene Dx OGD-510 device (DNA Genotek, FDA 510(k) # K141410). The collection kit is self-administrable, eliminating need for specialized training and minimizing risk due to close contact. After collection, the tube 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: Limit of Detection: 5 viral copies / μL Sensitivity: 98.3% Specificity: 98.8% Positive Predictive Value: 98.3% Negative Predictive Value: 98.8% Clinical & Stability Study: Clinical Performance: 91 Samples (35 positives and 57 negatives - confirmed by clinical assessment and qPCR testing by 3rd party EUA approved laboratories). Stability: 40 saliva samples analyzed at room temperature through live FedEx transport and through simulated temperatures between 22°C and 40°C for up to 56 hours.
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Use cases

Description

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COVID-19 use cases:
For use to aid detection of active virus and diagnosis of COVID-19 in individuals with associated symptoms, or for those with exposures to individuals with symptoms.
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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