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Pinnacle Biolabs COVID-19 Novel Coronavirus Dual IgG/IgM Rapid Test

Pinnacle Biolabs COVID-19 Novel Coronavirus Dual IgG/IgM Rapid Test

What Makes Our Test Unique? Unlike many competitors, The Pinnacle Biolabs COVID-19 Rapid Finger Stick Test is both HIGHLY SENSITIVE AND HIGHLY SPECIFIC.

  • The best antibody tests are both highly sensitive (meaning they detect a wide range of IgM or IgG antibodies that recognize different
    parts of a viral protein) and highly specific (meaning the detected antibodies are for only that virus)
  • Coronaviruses that cause colds, for example, also circulate around the globe. Antibody tests with low specificity and high sensitivity
    might detect antibodies against cold viruses and give a false positive. But a test with high specificity and low sensitivity could miss
    antibodies, resulting in a false negative.
  • Extensive clinical trials and third-party validation performed by the State of Delaware, Emory University, and George Mason University.
  • The Pinnacle Biolabs COVID-19 Rapid Finger Stick Test among a unique patient population with a wide range of comorbidities with zero False Positives. The Pinnacle Biolabs Test picked up the COVID-19 infections in every single test in the 3rd-party study.
Advantages 
  • Quick, Easy, Accurate
  • Rapid results within 8 to 15 minutes
  • Test has high Sensitivity and Specificity (99.4%)
  • To date the Pinnacle test has not produced a single false positive IgG
  • Cross reactivity testing zero
  • Intuitive and scalable design, with rational test interpretation
  • The Pinnacle test is an early step forward in macro global screening and reopening strategies
  • Provides wide range for detection and a path to providing a safe work environment
  • Enabled by detecting IgM/IgG antibodies related to the virus
  • NOT A SINGLE RETURN TO DATE
Manufactured in the US
  • 100% manufactured in the United States
  • Pinnacle Biolabs has partnered with Biomerics for production
  • On-line production facilities in Utah and Texas. Costa Rica for international manufacturing
  • Pinnacle Biolabs is well established in the Rapid Test space (pregnancy tests, colon cancer
    screening, etc.)
One kit includes
  • 25 tests, individually wrapped
  • 1 bottle of diluent
  • 25 pipettes
  • Instruction sheet
Kits do NOT include
  • Lancet
  • Alcohol swab

Why? The FDA deemed these items necessary to performing the test. By not including them, it deters someone from using it as an at-home test. TEST MUST BE PERFORMED BY A MEDICAL PROFESSIONAL.

Who should perform the test? Any medical professional can administer the test: nurse, nurse practitioner, physician’s assistant, phlebotomist, pharmacist, or pharmacy tech. Any facility that performs a flu shot or any form of on-site rapid medical testing would qualify.

FDA Presumptive Emergency Use Authorization #200240 Clinical trials for sensitivity, specificity, and cross reactivity completed and validated by independent third parties, including The State of Delaware, Emory University, and George Mason University.

Made in USA

Code: 370-004-GSG

Availability

For California Residents:

WARNING:Cancer and Reproductive Harm - www.P65Warnings.ca.gov

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