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Categories
Solutions
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EHR integrations
Client types
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Media
Company details
COVID-19 RT-qPCR Test
COVID-19 RT-qPCR Test

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Solutions

Description

Product 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.
About Phosphorus:
Assessing the full impact of the human genome has been limited by a number of fundamental challenges in a fragmented healthcare system. Providers do not often receive the resources to help interpret increasingly complex genomic data. Many hospitals and laboratories lack the informatics and expertise to properly build and handle high throughput sequencing. Genomic researchers often lack access to useful clinical data that could help bridge the gap between our DNA and our health. Phosphorus provides the solution through genomics as a service. Phosphorus provides services as a reference laboratory, as well as laboratory management programs.
Product 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.
About Phosphorus:
Assessing the full impact of the human genome has been limited by a number of fundamental challenges in a fragmented healthcare system. Providers do not often receive the resources to help interpret increasingly complex genomic data. Many hospitals and laboratories lack the informatics and expertise to properly build and handle high throughput sequencing. Genomic researchers often lack access to useful clinical data that could help bridge the gap between our DNA and our health. Phosphorus provides the solution through genomics as a service. Phosphorus provides services as a reference laboratory, as well as laboratory management programs.

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Company Details

Founded in 2016

Founded in 2016

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