LOS ANGELES COUNTY
DEPARTMENT OF MENTAL HEALTH
  Policy 355.01  COVID-19 Antigen Rapid Diagnostic Test
 
  PROCEDURES

Flowflex COVID-19 Antigen Home Test
  1. Equipment and Materials:
    1. Equipment:
      1. COVID-19 antigen rapid diagnostic test kit
    2. Materials:
      1. Gloves
  2. Prior to Performing Test
    1. The prescriber shall place the order in the Integrated Behavioral Health Information System (IBHIS) prior to authorized personnel performing the test.
    2. Authorized personnel shall review the order in IBHIS.
    3. Authorized personnel shall ask client to state or provide at least two (2) unique identifiers. Unique identifiers can be any combination of the following:
      • Last Name, First Name
      • Date of Birth (DOB)
      • IBHIS Number
      • Last 4 digits of Social Security Number (SSN)
      • Addess
      • Phone Number
    4. Obtain the following information from client and document in IBHIS:
      1. Preferred method of notification of test results
      2. Current COVID-19 symptoms, if any. Please also document if client reports no COVID-19 symptoms.
    5. Follow universal precautions.
  3. Explain procedures to the client and provide the necessary supplies, including a label with their full name and IBHIS number on the COVID-19 antigen rapid diagnostic test kit.
  4. Specimen Collections
    1. Authorized for clients aged two (2) years or older with symptoms of COVID-19 within seven (7) days of symptom onset.
      1. Anterior Nasal Swab Collection
        1. Wash or sanitize your hands. Make sure they are dry before starting the test.
        2. Open the test cassette pouch and lay the cassette on a clean, flat surface.
        3. Gently insert the entire absorbent tip of the swab into 1 nostril (1/2 to ¾ of an inch).
          1. With children, the maximum depth of insertion into the nostril may be less than ¾ of an inch.
          2. A false negative result may occur if the nasal swab specimen is not properly collected.
        4. Firmly rub the swab in a circular motion around the inside wall of the nostril five (5) times.
          1. Take approximately 15 seconds to collect the specimen.
          2. Be sure to collect any nasal drainage that may be present onto the swab.
          3. Repeat this in the other nostril using the same swab.
        5. Remove the swab from the nostril.
  5. Test Procedures
    1. Immediately place into the extraction buffer tube.
      1. Test samples immediately after collection, and no more than one hour after the swab is added to the reagent solution, if stored at room temperature.
      2. Immediately place the swab into the tube and swirl for 30 seconds.
        1. A false negative result may occur if the swab is not swirled for at least 30 seconds.
      3. Rotate the swab 5 times while squeezing the tube.
        1. A false negative result may occur if the swab is not rotated five times.
      4. Remove the swab while squeezing the tube to extract as much liquid as possible.
      5. Dispose of the swab in the trash.
      6. Attach the dropper tip firmly onto the tube.
      7. Mix thoroughly by swirling or flicking the bottom of the tube.
      8. Gently squeeze the tube and dispense four (4) drops of the solution into the sample well.
        1. A false negative or invalid result may occur if less than four (4) drops of fluid are added to the sample well.
      9. Dispose of the tube in the trash.
      10. Set the time for 15 minutes. The result should be read at 15 minutes.
        1. Do not read after 30 minutes. A false negative or false positive result may occur if the test result is read before 15 minutes or after 30 minutes.
      11. Dispose of the test cassette in the trash.
  6. Quality Control
    1. Internal procedural controls are included in the test.
      1. A red or pink line appearing in the control line region (C) is an internal procedural control.
      2. The appearance of the procedural control line indicates that the proper specimen volume has been added and capillary flow occurred.
      3. If the procedural control line does not develop in 15 minutes, the test result is considered invalid, and retesting with a new cassette is recommended.
  7. Result Interpretation
    1. Negative result:
      1. Only the control line (C) and no test line (T) appears. This means that no SARS-CoV-2 antigen was detected. A negative test result indicates that antigens from the virus that causes COVID-19 were not detected from the specimen. Negative results do not rule out COVID-19.
        1. Individuals without symptoms that test negative should be tested again within at least 24 hours and no more than 48 hours between tests.
        2. All negative results are considered presumptive, and confirmation with a molecular assay, if necessary for patient management, may be performed.
      2. Positive result
        1. Two red or pink lines appear in the test window, one on the test line position (T) and the other on the control line position (C). A positive test is interpreted as protein antigen from the virus that causes COVID-19 was detected in the specimen. The individual is positive for COVID-19.
          1. Test results should be considered in association with the patient’s history and epidemiological data (such as local prevalence rates and current outbreak/epicenter locations).
          2. The test line (red or pink line) may vary in shade and intensity (light or dark, weak or strong) depending on the concentration of antigen present in the sample.
          3. The intensity of the Control line should not be compared to that of the Test line for the interpretation of the test result. Any faint visible red or pink Test line should be interpreted as positive, when the control line (C) is also present.
      3. Invalid result:
        1. The Control line fails to appear. If a line does not appear on the control line position (C) in 30 minutes, the test result is invalid. This could be due to an insufficient volume of the sample solution being added to the test cassette.
          1. Re-test with a new Flowflex COVID-19 Antigen Home Test or gently squeeze the tube and dispense 4 drops of solution into the sample well of the test cassette.
      4. Limitations:
        1. The performance of this test was established based on the evaluation of a limited number of clinical specimens collected between March 2021 and May 2021.
        2. 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.
      5. 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.
  8. Report Test Results
    1. Authorized personnel shall report positive test results to the Department of Public Health (DPH) via www.SimpleReport.gov. Negative test results are not required to be reported to DPH.
    2. Reporting positive test results via SimpleReport
      1. Log in to SimpleReportSelect DMH site / clinic.
      2. Click on Conduct Tests tab
      3. Enter name of client
        1. Select correct client based on full name and date of birth.
        2. If client not yet added to the system, click Patients tab, +add patient, and enter client’s information before saving changes.
      4. Click Begin Test.
      5. Complete Patient Questionnaire, which includes:
        1. Method client would like to be notified of test results.
        2. Symptoms client reported at time of test.
      6. Select testing device and swab type from dropdown menus.
      7. Select result of COVID-19 test.
      8. Click submit once all questions have been completed.