OTC Rapid COVID-19 Antigen Nasal Test Kit (2-pack)

What is this rapid COVID test kit?

This rapid COVID test for sale is available for over the counter use for individuals and business owners looking to secure a supply of rapid COVID tests for onsite testing at home or in the office. This rapid test kit will give an easy to read result in about 15 minutes for an active COVID infection. This rapid test kit was also recently approved for a shallow nasal collection, making sample collection much more efficient and comfortable.

Disclosure:

This test has not been FDA cleared or approved; the test has been authorized by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the CLIA that meet the requirements to perform moderate, high or waived complexity tests. This test 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.

FDA Emergency Use Authorization Letter

Intended Use of Rapid COVID-19 Antigen Nasal Test Kit

• This COVID-19 Antigen test is a lateral flow immunochromatographic assay
  intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in
  nasopharyngeal swab specimens directly collected, or collected in BD universal transport media,
  from individuals suspected of COVID-19 by their healthcare provider within five days of symptom
  onset.
• This test is authorized for Over The Counter Use (OTC)
• Results are for the identification of the SARS-CoV-2 nucleocapsid protein antigen. The antigen
  is generally detectable in anterior nasal swab specimens during the acute phase of infection.
• Positive results indicate the presence of viral antigens, but the clinical correlation with patient
  history and other diagnostic information is necessary to determine infection status. Positive
  results do not rule out a bacterial infection or co-infection with other viruses. The agent detected
  may not be the definite cause of disease. Laboratories within the United States and its territories
  are required to report all results to the appropriate public health authorities.
• Negative results are presumptive and confirmation with a molecular assay, if necessary, for
  patient management may be performed. Negative results do not rule out SARS-CoV-2 infection
  and should not be used as the sole basis for treatment or patient management decisions,
  including infection control decisions. Negative results should be considered in the context of a
  patient’s recent exposures, history and the presence of clinical signs and symptoms consistent
  with COVID-19.

Specimen Collection and Preparation

• The Flowflex COVID-19 Antigen Home Test is performed using anterior nasal swab specimens.
• Wash or sanitize your hands. Make sure they are dry before starting the test.
• To collect an anterior nasal swab sample:

Directions For Use

1. Unscrew the dropper cap from the extraction buffer tube. Place the tube in the tube holder.
2. Immediately place the swab into the tube and swirl for 30 seconds.
3. Rotate the swab 5 times while squeezing the tube.
4. Remove the swab while squeezing the tube to extract as much liquid as possible. Dispose the swab in the trash.
5. Screw the dropper cap firmly onto the tube. Mix thoroughly by swirling or flicking the bottom of the tube. Remove the small cap from the dropper tip.
Note: A false negative result may occur if the swab is not swirled at least 30 seconds or rotated 5 times.
6. Gently squeeze the tube and dispense 4 drops of solution into the Sample Well. Dispose the tube in the trash.
Note: A false negative or invalid result may occur if less than 4 drops of fluid are added to the Sample Well.
7. Set the timer for 15 minutes. Result should be read at 15 minutes. Do not read after 30 minutes. Dispose the test cassette in the trash.
Note: A false negative or false positive result may occur if the test result is read before 15 minutes or after 30 minutes.

Interpretation Of Results

Summary of Antigen Testing

COVID-19 Antigen Tests are designed to detect protein antigen from the SARS-CoV-2 virus from nasal specimen samples. Antigen tests can detect the SARS-CoV-2 virus during the active phase of the infection. The collection process is only a couple of steps, and the results are directly onsite in about 15 minutes with no machinery required. Individuals can quickly and effectively test themselves and receive immediate results to help facilitate timely treatment decisions when using a rapid antigen test kit.
Similar to a PCR test, rapid antigen tests can detect the presence of the SARS-CoV-2 virus during the acute stage infection. Although much more efficient in providing timely results, rapid antigen tests can have a lower sensitivity rating when compared to PCR testing, Any negative result on a rapid antigen test should be verified with a PCR test confirmation to appropriately diagnose and treat the case.