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.
- 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
One kit includes
- 25 tests, individually wrapped
- 1 bottle of diluent
- 25 pipettes
- Instruction sheet
Kits do NOT include
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.