COVID-19 "CORONAVIRUS" IGG/IGM RAPID TEST KIT
- FDA Authorized on May 29, 2020 (EUA)
- Simple screening test with rapid results in minutes
- Small sample sizes
- Sold in packs of 100
- Following the incubation period, IgM may appear in blood within 3-5 days. IgG will appear as soon as 1-2 weeks.
- Shelf life of up to 24 months from manufacture date
- Medical Professional Use Only
- Tests should be conducted by a licensed phlebotomist, or a medical professional
- Verification of use case prior to shipping is mandatory
- Test to be performed in a CLIA moderate- or high-complexity setting
- Orders shipped from east coast and will wake 3-7 business days depending on recipient’s location
TEST KITS COME IN A BOX OF 100 at $14.00 PER TEST KIT | MINIMUM ORDER OF 1 BOX (100 TEST KITS).
HOW ACCURATE IS THE COVID-19 RAPID TEST?
This test has shown in clinical evaluation to have a total agreement of 97.19% and a kappa value of 0.94.
WHY OFFER IGG/IGM COVID-19 RAPID TESTING?
- Provide a Safer Work Environment for Your Employees: Coupled with your PPE program, you can ensure that your employees will come to work healthy and keep others (including patients and their families) safe. Testing also helps protect you from potential work-related and employee liabilities.
- Provide a Safer Clinic Environment for Your Patients: With testing, patients know that you are offering a safer clinic setting for all.
- Added Service: Provide a much-needed service for your patient and increase visibility and traffic flow to your traditional services.
- Increase Patient Traffic: Testing differentiates you from competitors who are not taking these measures to ensure the safety of staff and patients. Additionally, patients want to get tested and are willing to pay for it, but offering complimentary testing could be considered a marketing cost to help your practice increase treatment volumes – $14 cost to bring in a $450+ treatment.
This test has been authorized by FDA under an EUA for use by authorized laboratories.
This test has not been FDA cleared or approved.
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.