March 18, 2020
Phamatech, Inc. (San Diego, CA) today announces that, in light of the FDA updated policy on coronavirus diagnostic testing published on March 17, 2020, it will immediately introduce an instant point-of-care test device for the diagnosis of COVID19 infection, which will provide visual results in 10 minutes, available through healthcare providers.
Phamatech’s “2019-nCoV IgG/IgM Rapid Test” is an in vitro test for the qualitative detection of IgG and IgM antibodies specific to 2019-nCoV in human whole blood, serum or plasma specimen. A whole blood sample can be collected from a finger prick using a single-use disposable lancet, then add to the test device, which will provide visual results in 10 minutes.
The test is an easy-to-use on-site test which does not require any instruments or refrigeration. The test can be used in emergency room, physician's offices, nurses’ stations, medical clinics, pharmacies, drive through test stations, and even in-home setting to identify if symptomatic patients may be infected with COVID19.
Positive results of IgG/IgM antibodies indicate current and/or past exposure to COVID19.
Negative results indicate that the patient currently has not produced antibodies against COVID19.
Clinical testing has been performed in China against COVID19 infected and normal patients with 99% Relative Sensitivity, 98% Relative Specificity, and 98.6% Accuracy results for IgG; and 85% Relative Sensitivity, 96% Relative Specificity, and 93% Accuracy for IgM.
Phamatech’s “2019-nCoV IgG/IgM Rapid Test” is recommended for professional use in conjunction with clinical evaluation and results should be confirmed by other approved testing methods as required by CDC.
Test features include:
- On-site test - 10 minutes visual result - Highly Accurate
- No instrument or refrigeration required - No training required to perform the test
For questions, please call 1-858-643-5555