FDA Authorizes First
Point-of-Care Antibody Test for COVID-19

Point-of-Care IgG/IgM Antibody Test for COVID-19 CLIA Waived

Important information: This is not like a typical MCH BLOOD TEST

Supporting statements towards more Antibody Testing:

The CDC said that it recommends providers use multiple antibody tests on patients, and it obtains the most accurate tests available.

The CDC said that the prevalence of those testing positive for antibodies among the general population is between 5 and 25, with higher figures coming from areas with localized outbreaks.

The FDA has also warned that all antibody tests can produce false results, and that “broad use of the tests, when not appropriately informed by other relevant information, such as clinical history or diagnostic test results, could identify too many false-positive individuals.”

Serologic testing FDA approved for covid-19 Rapid Antibody Testing-EAU

Antibody Tests for past infections

An antibody test can show if you have previously been infected with the COVID-19 virus.

Antibody tests (also called serologic testing)

How is it POC done? A sample of blood is taken.

Where can you get these tests? At a doctor’s office, blood testing lab, or hospital.

What does the test look for? These blood tests identify antibodies that the body’s immune system has produced in response to the infection. While a serologic test cannot tell you if you have an infection now, it can accurately identify past infection.

What about accuracy? 

Having an antibody test too early can lead to false negative results. That’s because it takes a week or two after infection for your immune system to produce antibodies. The reported rate of false negatives is 20%. However, the range of false negatives is from 0% to 30%, depending on the study and when in the course of infection the test is performed.

COVID-19 IgG/IgM Point of Care RAPID TEST

What does POC authorization mean?

This authorization means finger stick blood samples can now be tested in POC settings like doctor’s offices, hospitals urgent care centers, and emergency rooms rather than having blood drawn to be tested in a central lab.

Why authorize a Point-of-Care Antibody Test for COVID-19?

“Authorizing point-of-care serology tests will enable more timely and convenient results
for individuals who want to understand if they have previously been infected with the
virus that causes COVID-19.”

Benefits:
• Results in 15 minutes
• High accuracy
• Easy to use
• No equipment required

Packing Contents:
• Tests
• Disposable pipettes
• Sterile safety lancet
• Buffer
• Package insert
• Alcohol Prep pad

Features:
• Packing Size: 20pcs/Box,640pcs/carton
• Sample: Whole Blood/Serum/Plasma
• Testing time: 15 minutes
• Shelf Life: 24 months
• Storage Condition: 2 °C ~ 30 °C

EUA Authorized Serology Test Performance – COVID-19 IgG/IgM Rapid Test Cassette

• Developer: Our Client
• Test: RightSign COVID-19 IgG/IgM Rapid Test Cassette
• Technology: Lateral Flow
• Target: Spike

CLIA Waived RAPID COVID-19 Antibody Test Bulk Wholesale Order 972-800-6670

Covid-19 IgG/IgM Rapid Antibody Test (CLIA WAIVED) Point Of Care Bulk / Wholesale Orders

Quick Reference Rapid Test POC

FDA essentially stating that be b111 or b21 strand is undetectable from current antigen tests

SEE FDA STATMENT

https://www.fda.gov/news-events/press-announcements/fda-issues-alert-regarding-sars-cov-2-vira

Rapid Decay of Anti–SARS-CoV-2 Antibodies in Persons with Mild Covid-19

*New England Journal of Medicine recent article suggested the rapid decay of anti–SARS-CoV-2 IgG in early infection,¹ but the rate was not described in detail. We evaluated persons who had recovered from Covid-19 and referred themselves to our institution for observational research.

Citations: New England Journal Of Medicine site, page: doi/full/10.1056/NEJMc2025179?query=RP