Healgen OrientGene

COVID-19 IgM/IgG Rapid Test
  • Authorized for Emergency Use by the FDA
  • Provides results within 5-10 minutes
  • Designed for use with whole blood, serum or plasma samples with a high degree of accuracy
  • Sold in packs of 25
  • Shelf life of up to 24 months from manufacture date

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.

Additional Product Information

Are These Tests FDA Approved?

These tests are authorized by the FDA for emergency use as of May 29, 2020. On March 16th, 2020 the FDA published a guideline to cover this that can be found on the FDA website.

COVID-19 Rapid Blood Tests for use by laboratories and healthcare workers at the point-of-care, have not been approved by the FDA. The FDA does not intend to object to the development and distribution of serology tests by commercial manufacturers or laboratories that identify antibodies to SARS-CoV-2 where (1) the test has been validated, (2) notification has been provided to the FDA, and (3) the following information is included in the test report: These test have not been reviewed by the FDA. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic test should be considered to rule out infection in these individuals. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. 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 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.

Included In Each Box of Test Kits

25 sealed pouches (each containing a test cassette, dropper, and desiccant)
1 buffer vial
1 package insert

Price Summary

Contact us for specific pricing information. Bulk discounts are available.

Clinical Evaluation Results

One June 6, 2020, The National Cancer Institute (NCI) has released the testing results for the Helagen test offered by Amplicon. With the RT-PCR test as the gold standard, the results showed 97% sensitivity and 98% specificity with IgG, 100% sensitivity and 100% specificity with IgM, and 100% sensitivity and 98% specificity when combining IgG and IgM results.

About the Manufacturer

Healgen Scientific, a wholly owned subsidiary of Zhejiang Orient Gene Biotech Co.,Ltd, develops, manufactures and commercializes in-vitro diagnostic test systems worldwide. It was founded in 2005 and researches, develops, manufactures, and sells vitro diagnostic products. The Company offers genetic diagnosis, colloidal gold rapid diagnostic tests, dry chemical strips, bio-liquid diagnostic kits, clinical test instruments, and other related raw materials.

View Establishment Registration. ZHEJIANG ORIENT GENE BIOTECH manufactures 122 tests under FDA registration View All Device Listings and are registered to produce OrientGene Covid-19 IgG & IgM Test. View OrientGene Device Listing.