INSTANT COVID-19 TESTING CAPABILITIES
PSS Rapid COVID-19 Testing: Get Back to Work with INSTANT COVID-19 TESTING
Potawatomi Support Services (PSS) offers a turnkey comprehensive solution for COVID-19 testing. PSS uses the FDA Emergency Use Authorized Confirm Biosciences’ COVID-19 “Coronavirus” IgG/IgM Rapid Test Kit to conduct COVID-19 screen tests, with confirmatory PCR tests utilizing Co-Diagnostics' Logix Smart™ COVID-19 Test kit and CoDx Box™ cutting-edge advanced qPCR cycler. PSS has designed their program to administer rapid antibody testing kits in the field and confirmatory testing in the laboratory. Our solution provides FDA and CLIA compliant, scientifically reliable screen testing and confirmations at a cost and speed that allows organizations to more accurately make decisions to manage the current health crisis. Highlights of our Rapid COVID-19 Testing include:
Finger Prick Blood Sample, Rapid COVID-19 Testing
Accurate Results, on the spot, in less than 5 minutes (97.19% Efficacy Rate)
We offer a “full-spectrum” Rapid COVID-19 Testing solution and the ability for our customers to customize our support and services to meet their needs. Our full-spectrum COVID-19 Testing Solution includes:
Licensed medical professionals to administer the test and recommend next steps
A Test-Result tracing application that integrates with the rapid test for authenticity verification and real-time result capture
COVID-19 ‘Screen and Confirm’ Testing Approach
We recommend a two-stage approach to testing; starting with wide use of cost effective, fast and highly accurate screen tests; then the more expensive confirmatory PCR tests for those that screen positive or are symptomatic. Given the evidence that a very high percentage of those tested will be negative but have to endure lengthy delays and high costs for PCR tests, we recommend organizations take a ‘screen and confirm’ approach to their testing. Beechtree Diagnostics can manage the end to end process from collection through screen testing, confirmations and timely results on our advanced reporting application powered by Rymedi’s fully HIPAA, GDPR compliant platform designed to produce CFR21.11 compliant Real-World Evidence.
PCR Confirmatory Test
The Logix Smart™ COVID-19 Test kit is an in vitro diagnostic test that uses patented CoPrimer™ technology for the qualitative detection of the RNA from SARS-CoV-2 coronavirus (COVID-19). The test operates using a single step real-time reverse transcriptase polymerase chain reaction (RT-PCR) process in lower and upper respiratory tract fluids. The test is conducted in the laboratory on the CoDx Box™, cutting-edge magnetic induction technology powering the most advanced qPCR cycler ever.
Anti-Body Screen Test
Testing capabilities have evolved quickly through this crisis. There are two primary testing types: Antibody and PCR Testing. Unfortunately, there are significant challenges with PCR testing, principally due to supply chain issues for test kits and reagents. The FDA Emergency Use Authorized COVID-19 IgG/IgM Rapid test kits provide a cost effective, timely, accurate and reliable solution. They allow organizations to screen high numbers quickly, only confirming where symptomatic or a positive screen result. PSS also offers an at-home testing solution with Global 7 Diagnostics at-home collection kits.
FDA Emergency Use Authorized Coronavirus (COVID-19) Instant Test Kits (For Medical Professional Use Only)
FDA Emergency Use Authorization (EUA)
Rapid results within 10 minutes
Small sample size
Sold in packs of 25
Shelf life of up to 24 months from manufacture date
Test to be performed in a CLIA moderate- or high-complexity setting *
Verification of use case prior to shipping is mandatory
IgG and IgM Controls are now available
* The FDA has only granted this test emergency use authorization in a CLIA moderate- or high-complexity setting. Please refer to your local regulations. To learn more, download the FDA Fact Sheet: Antibody Test Oversight and Use For COVID-19.
OUR COMMITMENT AND SERVICE
PSS is committed to providing an end to end ‘screen and confirm’ solution with scientifically accurate, professional and timely results. We also deliver on the ground collection services as part of the service. We are a strong community partner, which includes the hiring and training of staff, thereby supporting the local economy.