COVID-19 Antibody Tests — PLYMOUTH MEDICAL

KEY FEATURES OF OUR ANTIBODY TESTS


Screen%2BShot%2B2020-05-31%2Bat%2B1.12.16%2BAM.jpg

HEALGEN TEST

  • Provides positive/negative results in 10-15 minutes.

  • Increased screening with IgM and IgG antibody detection.

  • Ideal high volume screening device to compliment nucleic acid tests.

  • Indication for Use: Lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2.

  • Clinical Sensitivity: 93.87%

  • Clinical Specificity: 99.10%

  • Relative Accuracy: 97.19%

  • # Tests vs RT-PCR (n): 704

  • Shelf Life: 24 months

  • No instrument required

  • Made in China

  • CLIA Authorized Settings: High Complexity Labs, Moderate Complexity Labs

  • Can be performed using either venous whole blood, serum or plasma (not finger stick specimens).


Screen Shot 2020-10-01 at 9.50.17 PM.png

ASSURE TEST

 

SUPPORT DOCUMENTS

 

GENERAL COVID-19 DOCUMENTS



PRICING


HEALGEN TEST

$200

Pack of 25

includes Test Cassettes, Pipettes and Buffer Solution

Lancets are not included/needed as this test is intended to be used with venous whole blood, plasma, or serum (not finger stick).

This product is only available to high and/or moderate complexity CLIA labs. The purchaser will be asked to provide the CLIA lab license/certificate number at checkout.


ASSURE TEST

3.png

$240

Pack of 20

includes Test Cassettes, Pipettes, Lancets, Alcohol Swabs and Buffer Solution

Intended to be used with venous whole blood, plasma, serum or finger stick.

This product is available to CLIA waived point of care (POC) settings.

 

FREQUENTLY ASKED QUESTIONS


WARNING

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.


IMPORTANT NOTIFICATION

The FDA continues to update its guidance in its FAQ section. It is important to check their website daily for latest updates: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/faqs-diagnostic-testing-sars-cov-2.



Do you have any further questions?

Please contact us at sales@plymouthmedical.com or call our customer service hotline at 888-392-5076 Ext.1.


FDA WEBPAGE: 

www.fda.gov/novelcoronavirus 

CDC WEBPAGE: 

www.cdc.gov/COVID19