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

CareStart COVID-19 Antigen Point-of-Care 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. 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)
      •    Address
      •    Phone Number
       
    4. Obtain the following information from client and document in IBHIS: 
         a. Preferred method of notification of test results
        b. 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 Collection
     
    1. Samples shall be collected from clients within the first five (5) days of symptom onset, from clients without symptoms, or from clients who have other epidemiological reasons to suspect COVID-19 when tested twice over two (2) or three (3) days with at least 24 hours and no more than 48 hours between tests.
       
    2. Nasopharyngeal Swab Collection
      1. Remove the nasopharyngeal swab from the pouch.
      2. Tilt the client's head back 70 degrees.
      3. Gently and slowly insert the swab into one of the nostrils until it reaches the posterior nasopharynx.
      4. Keep inserted until resistance is encountered or the distance is equivalent to that from the ear to the client's nostril.
      5. Slowly rotate the swab three (3) to five (5) times over the surface of the posterior nasopharynx.
      6. Leave the swab in place for several seconds to absorb secretions.
      7. Slowly remove the swab from the nostril while rotating it.
         
    3. Anterior Nasal Swab Collection
      1. Remove the nasopharyngeal swab from the pouch.
      2. Insert the swab into one (1) of the nostrils up to one (1) inch from the edge of the nostril.
      3. Slowly roll the swab over the surface of the nostril five (5) times.
      4. Using the same swab, repeat this collection process in the other nostril.
      5. Collect specimen over approximately 15 seconds.
      6. Slowly remove the swab from the nostril while rotating it.
         
  5. Test Procedure
     
    1. Allow test devices, reagents, specimens, and/or controls to equilibrate to room temperature prior to testing.
       
    2. Remove the COVID-19 antigen test device and extraction vial from its foil pouch immediately before testing.
       
    3. Peel off the aluminum foil seal from the top of the extraction vial containing the extraction buffer.
       
    4. Place the swab into the extraction vial and swab vigorously at least five (5) times.
       
    5. Remove the swab by rotating against the extraction vial while squeezing the sides of the vial to release the liquid from the swab.
       
    6. Properly discard the swab.
       
    7. Close the vial with the provided cap and push firmly onto the vial.
       
    8. Mix thoroughly by flicking the bottom of the tube.
       
    9. Invert the extraction vial and hold the sample vertically above the sample well.
       
    10. Squeeze the vial gently and allow three (3) drops of sample to fall into the sample well.
      1. Two (2) drops of the sample are the required minimum volume to initiate the test run.
      2. Invalid results will be obtained if one (1) drop of sample is added to the cassette.
      3. Leakage of the sample is possible when six (6) drops or more of the sample are added.
         
    11. Read and interpret the test result at 10 minutes.
      1. The test result should not be read and interpreted after 15 minutes.
         
  6. Quality Control
     
    1. Run positive and negative external control swab provided in the kit with every new lot.
       
    2. Contact manufacturer if external control results are invalid.
       
  7. Result Interpretation
     
    1. Negative result 
      1. One red-colored line only next to “C” indicates a negative result.
    2. Positive result
      1. Two (2) distinct colored lines appear. One red-colored line next to “C” and one blue-colored line next to “T” indicate a COVID-19 positive result. Any faint colored line(s) in the test region(s) should be considered positive.
    3. Invalid result
      1. If the red-colored line in the control region “C” ” is not visible, the result is invalid. Re-run the test one time using the remaining specimen in the extraction vial if an invalid result is obtained during initial testing.
    4. False Positive Test
      1. May occur if the test is interpreted outside of the interpretation window.
         
    5. False Negative Test
      1. May occur if the test is interpreted outside of the interpretation window.
      2. Incorrect specimen collection method.
      3. Inadequate specimen collection.
      4. Improper specimen handling and/or transport.
         
  8. Documentation
    1. Authorized personnel shall document results in IBHIS as a point-of-care COVID-19 antigen test result.
       
  9. 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 SimpleReport.
      2. Select DMH site / clinic. 
      3. Click on Conduct Tests tab.
      4. 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.
      5. Click Begin Test.
      6. Complete Patient Questionnaire, which includes:
        1. Method client would like to be notified of test results.
        2. Symptoms client reported at time of test.
      7. Select testing device and swab type from dropdown menus.
      8. Select result of COVID-19 test.
      9. Click submit once all questions have been completed.