The COVID19 IgG/IgMRapid Response Test Kit

The COVID19 IgG/IgM Rapid Response Test Kit, manufactured by Phamatech, Inc. (San Diego, CA), is a 10-minute instant point-of-care test device for the qualitative detection of IgG and IgM antibodies specific to the 2019-nCoV in human whole blood, serum or plasma.

Important

• This test is 98.6% accurate for detection of the IgM antibodies specific to 2019-nCoV
• This test is 93% accurate for detection of the IgG antibodies specific to 2019-nCoV
• This test was developed in Belgium and is manufactured in the USA – San Diego, CA.
• THE USFDA updated their guidance, issued on March 16, 2020, to allow the distribution of this product for use by Healthcare worker, at point-of-care facilities and for diagnostic use in laboratories during the COVID19 pandemic.
• All Test results are presumptive and should be confirmed by an approved molecular assay. A presumptive negative test does not preclude the 2019n-CoV infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, a presumptive positive result does not rule out infections caused by other viruses.
• If you get positive antibodies then you still need the swab (PCR) to make sure you are not a carrier.

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.