NOTE: SOLD TO HEALTHCARE PRACTITIONERS ONLY
FDA EUA 200056
Sold by the kit. Each kit contains 25 tests. ($25 per test)
The COVID-19 Antibodies IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology that is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM (early marker) and IgG (late marker) antibodies.
In general, IgM antibodies are formed initially by the patient at about the time that symptoms first appear. These antibodies will dissipate after about one month. IgG antibodies are second to appear in the body, about one week after symptoms appear. They will continue to be present in the bloodstream for a prolonged period of time.
Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals.
Each Antibodies Test Kit (25 Tests) contains:
- 25 Rapid Test Cassettes (Individually packed with desiccant)
- 25 Droppers
- 25 Lancets (for finger prick)
- 25 Alcohol Prep Pads
- 1 Buffer Solution
- 1 Package Insert
The exam and the test are now reimbursable.
- Doctors office CPT Code: 99211
- Test CPT Code: 86328
Medicare pays double $50 for 86328 and $21 for 99211. So the clinic is looking at roughly $70 reimbursement per patient.
CLICK HERE for Complete Information and Instructions
CLICK HERE for FDA Letter
CLICK HERE for Brand Statement
Why Antibodies Test?
The antibody test is helpful in many ways:
- As many people who have COVID-19 infection show no or mild signs and symptoms of illness, antibody tests could be useful in determining if you had the virus without knowing. It could also help guide your doctor in making clinical decisions about your care.
- Antibody tests could also help determine individuals who qualify to donate convalescent plasma, a component of blood that contains antibodies. Convalescent plasma therapy uses blood donations from recovered patients to help treat others with COVID-19 infection.
- The antibody test is viewed as a key to help develop a vaccine for the virus. The bodyâ€™s response to a potential vaccine is directly correlated with the antibodies built by the body.
- Many countries and communities around the globe have adopted widespread antibody testing to better understand the true infection rate and how deadly the virus is. This data will be helpful to predict how COVID-19 might affect us in the future, including why some people are more severely impacted than others. Finally, the antibody test results are also helpful in contact tracing to assess who else is at risk of infection and how far the disease spread. All of this data will help improve strategies to curb the COVID-19 pandemic.
The antibody test is seen as a key to reopen the country, restart the economy, and reintegrate society.
Benefits of Antibody test
- Know your status
- Screen donors for convalescent plasma therapy
- Develop effective vaccine
- Understand disease prevalence
- Contract tracing
Features & Specifications
- â€‹Facilitates patient treatment decisions quickly
- Detection window (IgM): 3-5 days for Symptomatic. 7 days for Asymptomatic
- No clinical equipment or facilities needed
- Dual-band results for simple interpretation
- Multivariable analysis of immunoglobin IgG & IgM
According to the new FDA policy, the serological antibodies tests can be used by â€œpoint-of-careâ€ facilities, including laboratories, hospitals, clinics, physicianâ€™s offices, and where healthcare workers are involved in treating and/or testing patients. However, â€œresults from antibody testing are presumptive and should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection statusâ€.
WHAT DO THE RESULTS MEAN?
An IgM positive resultÂ indicates current or recent infection with the SARS-CoV-2 virus. IgM antibodies are usually detected 3-5 days post symptom onset in symptomatic patients and around 7 days post-infection in asymptomatic patients.
AnÂ IgG positive resultÂ indicates past exposure to SARS-CoV-2. IgG antibodies are usually produced 21 days post-infection and can be detected for months to years later. The duration of human immunity to SARS-CoV-2 remains to be determined.
Both IgM and IgG positive resultsÂ indicate recent SARS-CoV-2 infection that occurred between one to two months prior to performed test.
A Negative resultÂ does not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with other clinical observations, patient history, and epidemiological information.
If the test result is negative and clinical symptoms, additional follow-up testing using other clinical methods is suggested. A negative result at any time does not preclude the possibility ofÂ COVID19 infections.
- Hygienic Product : No
- Allergy : Not Specified
- UPC:Not Specified
- GTIN/ITF Barcode : Not Specified
- Units of Measure : Not Specified
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- Weight Capacity : Not Specified lbs
- Actual Product Weight : 0.3 lbs
- Product Assembly : No
- Product Installation : No
- Country of Origin :Â USA
- Case QTY : Not Specified/case
- Case Weight : Not Specified
- Ships Via Freight : No
- Proposition 65 Warning : Not Specified
- Hygienic Product : Not Specified
- Allergy : Not Specified