The TekiTrust™ COVID-19 IgG Rapid Test is a lateral flow immunoassay intended for qualitative detection of IgG antibodies to SARS-CoV-2 in human serum, venous whole blood (sodium heparin, lithium heparin, sodium citrate and tripotassium EDTA), plasma (sodium heparin, lithium heparin, sodium citrate and tripotassium EDTA), and fingerstick whole blood. The TekiTrust™ COVID-19 IgG Rapid Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The TekiTrust™ COVID-19 IgG Rapid Test should not be used to diagnose or exclude acute SARS-CoV-2 infection. Results are for the detection of SARS-CoV-2 antibodies. IgG antibodies to SARSCoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion. The TekiTrust™ COVID-19 IgG Rapid Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.
Product Specifications

PRECAUTIONS AND WARNINGS
  • Test Cassettes are single use only. Do not reuse.
  • For use under Emergency Use Authorization only. For in vitro Diagnostic use only.
  • This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories.
  • This product has been authorized only for detecting the presence of IgG antibodies to SARS-CoV-2, not for any other viruses or pathogens.
  • The emergency use of this product 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
  • Do not use tests after the expiration date.
  • Test Cassette should remain in the sealed pouch until use because it is sensitive to moisture. Use Test Cassette immediately after opening the pouch.
  • Do not use the Test Cassette if it is broken or the pouch is not stored in sealed.
  • Samples and Test Cassette must be at room temperature before testing.
  • Please be cautious when handling the Test Cassette and samples because of the use of clinical samples containing potential infectious sources. Dispose of the used samples and Test Cassettes properly in accordance with the relevant regulations.
  • Smoking and eating are prohibited at test site when handing specimens or kit reagents.
  • This product was tested on serum, venous whole blood (sodium heparin, lithium heparin, sodium citrate, and tripotassium EDTA), and plasma (sodium heparin, lithium heparin, sodium citrate, and tripotassium EDTA) as anticoagulants. Using other anticoagulants may produce different results.
  • Testing of serum, plasma and venous blood specimens is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet requirements to perform moderate or high complexity tests. Testing of fingerstick whole blood specimens is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high, moderate or waived complexity tests. Testing of fingerstick whole blood specimens is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
LIMITATIONS OF THE SYSTEM
  • This test is not for home use.
  • The test is for qualitative detection of anti-SARS-CoV-2 IgG antibody in human whole blood, serum or plasma and does not indicate the quantity of the antibodies. The intensity of the test line does not necessarily correlate to SARS-CoV-2 antibody titer in the specimen.
  • Performance has only been established with the specimen types listed in the Intended Use. Other specimen types have not been evaluated and should not be used with this assay.
  • The test results should be interpreted between 10 and 30 minutes after addition of buffer. The test results should not be interpreted after 30 minutes.
  • The test is for in-vitro diagnostic use only.
  • Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. The sensitivity of the TekiTrust™ COVID-19 IgG Rapid Test early after infection is unknown. False positive results for IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes.
  • A negative result can occur if the quantity of antibodies for the SARS-CoV-2 virus present in the specimen is below the detection limit of the assay, or if the virus has undergone minor amino acid mutation(s) in the epitope recognized by the antibody used in the test.
  • Testing with a molecular diagnostic should be performed to evaluate symptomatic patients for acute SARS-CoV-2 infection, particularly in those who have been in contact with the virus.
  • Results from antibody testing should not be used to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
  • A positive result may not indicate previous SARS-CoV-2 infection. Consider other information, including clinical history and local disease prevalence, in assessing the need for a second but different serology test to confirm an immune response. 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.
  • It is not known at this time if the presence of antibodies to SARS-CoV-2 confers immunity to reinfection.
  • Not for the screening of donated blood.
  • SARS-CoV-2 antibodies may be below detectable levels in patients who have been exhibiting symptoms for less than 15 days.
  • Testing must be performed immediately after opening the pouch.
  • The performance of this device has not been established in individuals that have received a COVID-19 vaccine. The clinical significance of a positive or negative antibody result following COVID-19 vaccination has not been established, and the result from this assay should not be interpreted as an indication or degree of protection from infection after vaccination.
  • The performance of this test was established based on the evaluation of a limited number of clinical specimens collected from the United States between February 2020 and June 2020 for serum, venous whole blood (sodium heparin, lithium heparin, sodium citrate and tripotassium EDTA), and plasma (sodium heparin, lithium heparin, sodium citrate and tripotassium EDTA) and between November 2020 and January 2021 for fingerstick whole blood. The clinical performance has not been established in all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time.