CorDx Tyfast COVID-19 Ag Rapid Test For in vitro diagnostic use For use with anterior nasal swab specimens For technical support, please email [email protected] or contact +1-800-711-5355. 1 / 15

The CorDx Tyfast COVID-19 Ag Rapid Test is a visually read lateral flow immunoassay device intended for the rapid, qualitative detection of SARS-CoV-2 virus nucleocapsid protein antigen directly in anterior nasal swab specimens from individuals with signs and symptoms of COVID19. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged 2 years or older. The CorDx Tyfast COVID-19 Ag Rapid Test does not differentiate between SARS-CoV and SARS-CoV-2. All negative results are presumptive. Symptomatic individuals with an...

At-Home (OTC) acute respiratory illness (i.e. cough, dyspnea) although some individuals experience mild symptoms or are asymptomatic. The virus is spread primarily from person to person through respiratory particles, even by individuals without symptoms. The CorDx Tyfast COVID-19 Ag Rapid Test is a rapid, immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect nucleocapsid protein from SARS-CoV-2 from anterior nasal swab specimens. The test kit includes the: test cassette, swab, tube with sample processing solution, tube holder (back of the box) and the...

At-Home (OTC) • This product is only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. • Serial testing should be performed in individuals with negative results at least twice over three days (with 48 hours between tests) for symptomatic individuals and three times over five days (with at least 48 hours between tests) for asymptomatic individuals. You may need to purchase additional tests to perform this serial (repeat) testing. • An anterior nasal swab sample can be self-collected by an individual aged 14 years and older. Children aged 2 to 13 years should...

At-Home (OTC)6. STORAGE AND STABILITY Store the CorDx Tyfast COVID-19 Ag Rapid Test between 36-86°F (2-30°C) in a place out of direct sunlight and out of reach of children. Reagents and devices must be used at room temperature (59-86°F/15-30°C). The unsealed cassette is valid for 1 hour. It is recommended to use the test kit immediately after opening. The expiration date assigned at manufacturing is on the package. Each CorDx Tyfast COVID-19 Ag Rapid Test has a built-in "Control” region which serves as an internal procedural control when a colored line appears in the control line region ("C line”)....

At-Home (OTC) STEP 2: PROCESS SAMPLE (4) Insert the swab into the tube until it touches the bottom. (5) Rotate the swab at least 10 times while pressing the swab head against the bottom and side of the tube. (6) Remove the swab while squeezing the sides of the tube to express as much liquid as possible from the swab. (7) Attach the dropper tip firmly onto the tube. (8) Gently squeeze the tube and dispense 3 drops of solution in the sample well. Note: Invalid results can occur if less than 3 drops STEP 4: READ RESULT (9) Wait 10 minutes. (10) Read the result at 10 minutes. Do not read the result...

At-Home (OTC) Results should be considered in the context of an individual’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19. Invalid If the control (C) line is not visible, the test is invalid. Re-test with a new swab and new test device. An invalid result does not indicate if the individual did or did not have COVID-19 and should be repeated. COVID-19 Positive (+) If the Control (C) line and the Test (T) line are visible, the test is positive. NOTE: Any red or pink line in the correct, indicated locations, no matter how faint, should be considered...

At-Home (OTC) 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. • If the patient continues to have symptoms of COVID-19, and both the patient’s first and second tests are negative, the patient may not have COVID-19, however additional follow-up may be needed. • This test is read visually. Because test lines can be very faint, users with conditions...

At-Home (OTC) (Lineage B.1.351), Delta (Lineage B.1.617.2), Omicron (Lineage B.1.1.529, XBB), B.1595, Omicron B.1.1.529, BA.1 (NIBSC 21/368), USA-WA1/2020 (Heat-Inactivated) and USA-WA1/2020 (UV-Inactivated) were spiked into pooled negative sample matrix (PNSM) to determine the LoD for each tested variant. Based on the results, the CorDx TyFast COVID-19 Ag Rapid Test detects SARS-CoV-2 variants with LoD at the concentrations as indicated. The assay can detect these variants near the LoD of the original SARS-CoV-2 virus and thus displays comparable sensitivity and acceptable inclusivity for these...

At-Home (OTC) Rhinovirus Type 1A To estimate the likelihood of cross reactivity for organisms that were not available for wet testing, in silico analysis using the Basic local Alignment Search Tool (BLAST) managed by the National Center for Biotechnology Information (NCBI) was used to assess the degree of protein sequence homology. Human coronavirus HKU1, Mycobacterium tuberculosis and Pneumocystis jirovecii were analyzed as shown below. • Based on sequence and epitope analyses, a potential for cross-reactivity between the SARS-CoV-2 test and HKU1 exists. Wet testing for HKU1 coronavirus has...

At-Home (OTC) CVS Nasal Spray (Cromolyn) No hook effect was observed for specimens containing SARS-CoV-2 viral concentration as high as 4.57x106 TCID50/ mL. The purpose of the study was to assess lot-to-lot variability of three different lots of the CorDx Tyfast COVID-19 Ag Rapid Test kit. The study includes a sample panel consisting of a negative sample, a low positive (2 x LoD) sample, and a medium positive (4.0x LoD) sample. The low positive and medium positive sample were prepared by spiking UV-inactivated SARS-CoV-2 in the negative sample matrix (NSM). Each operator applied 50 ^L of each...