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LED BY PASSIONATE EXPERTS Progress Medical is an authorized distributor
of the FDA Emergency Use Authorized - Assure
COVID-19 IgG/IgM Rapid Antibody Test,
The Infinity BiologiX Qualitative PCR
Detection Test with Saliva and the Becton
Dickinson BD Veritor System for Rapid Detection
of SARS-CoV-2.

COVID-19 Antibody Test

Progress Medical is doing our part to help navigate through these trying times in dealing with the COVID-19 Virus. Testing can be implemented for any Organization or School utilizing a healthcare provider and the software solution. Below is guidance for a back to work plan.

Progress Medical now offers a complete COVID-19 Testing Solution combining Rapid Antibody, Detection via Rapid Antigen and PCR Saliva Testing with software management

Assure FDA EUA COVID-19 IgG/IgM Rapid Antibody Test

The COVID-19 IgG/IgM Rapid Test Device is an in vitro immunoassay for the direct and qualitative detection of anti-SARS-CoV-2 and
anti-SARS-CoV-2 IgG in human whole blood, serum or plasma.  This is the first antibody test to receive authorization for point of care utilizing a fingerstick.

  • Results in 15 minutes
  • Easy to use
  • No equipment required
  • High accuracy

Combined Sensitivity 100%
Combined Specificity 98.8%

FDA EUA BD Veritor System for Rapid Detection of SARS-CoV-2

When you need fast, reliable SARS-CoV-2 testing, turn to the BD Veritor Plus System.  This offers lab quality results at the point of care, in a simple-to-operate, handheld instrument.

  • Simplify the testing process
  • Achieve fast, reliable results
  • Provide workflow efficiency
  • Provide result traceability
Infinity BiologiX FDA EUA Qualitative Detection with Saliva (PCR)
  • Saliva sample determines active infection of SARS-CoV-2 virus
  • First FDA EUA Saliva test approved for an at-home saliva sample collection
  • Secure digital lab results with 72 hours of receiving the sample
  • Replaces uncomfortable Nasal Swab test
  • Spit into a tester and mail to the lab
  • High accuracy
COVID-19 SOFTWARE SOLUTION utilized with PCR Saliva Test
Test Results, Patient Education, & Compliance Software

With each test, we offer a Patient Communication, Patient Education, & Health Assessment Surveys regarding COVID-19 to healthcare providers at no cost.

This automated tool allows providers to effectively communicate with their patients:

  • Accurate CDC Patient Education COVID Health Assesment Survey (CVDHA)
  • Health Assesment Tracking & Results PROMIS Global Health Survey
  • Quarantine Guidance
  • Ability to include other custom surveys

The COVID Health Assessment Survey (CVDHA) will be sent automatically to patients within an educational Care Pathway and then resent at a cadence of 1, 2, 3, 4, and 6 weeks for continued risk assessment.

The HIPAA-Secure platform enables patients to access accurate, reliable information from a provider they trust and safely increase patient-provider communication. It also provides a way for healthcare providers to track patient symptoms, evaluate health risks, and encourage informed patient engagement.

ASSURE FDA EUA COVID-19 ANTIBODY TEST

The COVID-19 IgG/IgM Rapid Test is a 15-minute instant point-of-care test device for the qualitative detection of IgG and IgM antibodies specific to 2019-nCoV in human blood, serum, or plasma specimens.

What is COVID-19?

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

Indication:

The Assure COVID-19 IgG/IgM Rapid Test Device is a rapid lateral flow chromatographic immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and fingerstick whole blood.  Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories.

Warning:

  • This test has not been FDA cleared or approved;
  •  This test has been authorized by FDA under an EUA for use by authorized laboratories;
  • This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
  •  This product is intended for professional use and not for home use.
  •  Not for the screening of donated blood.

FDA EUA BD Veritor System for Rapid Detection of SARS-CoV-2

This test is authorized for use at the Point of Care (POC), i.e. in-patient care setting under a CLIA. Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Progress Medical can provide guidance on how to receive a Certificate of Waiver in under two weeks, should you need one.

The following tests can be offered with the BD Veritor System:

BD Veritor System COVID Tests 30 tests/kit
Influenza A+B POC Kit, CLIA Waived, 30 tests/kit
RSV Test Kit, CLIA Waived, 30 tests/kit
Strep A Test Kit, CLIA Waived, 30 tests

Infinity BiologiX COVID-19 PCR DETECTION TEST WITH SALIVA

How does this test work?

This is a polymerase chain reaction (PCR) test. It is a relatively simple and widely used molecular biology technique to amplify and detect DNA and RNA sequences and takes only a few hours. The test detects the expression of three genes specific to the SARS-CoV-2 virus, the NS, and ORF1ab genes. Viral RNA is extracted from the patient’s saliva sample and the presence of gene sequences is assessed. If the presence of 2 or 3 of these gene transcripts is confirmed, the test is considered POSITIVE.

How accurate is this test?

The assay can detect the virus down to fewer than 10 copies per milliliter of saliva, which is highly sensitive. In practice, 98% of test results are either positive or negative, with only 2% being inconclusive.  The sequences that help to detect the virus (primers) match the viral sequences almost 100% of the time, which ensures that the test is specific only to the 3 selected viral genes, which in combination are only found in the SARS-CoV-2 virus.

We want to help everyone get back to normal as quickly as possible, so please consider allowing us to set up a Testing program that is right for you!

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