LOS ANGELES COUNTY
DEPARTMENT OF MENTAL HEALTH
  Policy 355.08 HIV Point-of-Care Test - Whole Blood
 
Policy Category:  Clinical
Distribution Level:  Directly Operated
Responsible Party: Pharmacy and Therapeutics Committee
 
Approved by Curley L. Bonds, MD, Chief Medical Officer, on Dec 08, 2023
 
I.  PURPOSE
 
This policy establishes the use of INSTI HIV-1/HIV-2 Antibody diagnostic test for the detection of HIV-1 and HIV-2 antibodies in clients at Los Angeles County Department of Mental Health (DMH) directly operated clinics.
 
II.  DEFINITIONS
 

Authorized personnel: physician, registered nurse, licensed vocational nurse, nurse practitioner, psychiatric technician, clinical pharmacist.

Clinic: Any DMH directly operated facility.

INSTI HIV-1/HIV-2 Antibody Test: CLIA-waived in-vitro point-of-care (POC) qualitative test for the accurate detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in venous whole blood, fingerstick blood and plasma.

 

III.  POLICY
 
Use universal precaution for infectious materials in handling and disposing of specimens and used test materials.

Only Authorized Personnel shall perform HIV POC test.

Clinical competency shall be demonstrated to and deemed satisfactory by Chief of Nursing or designee on annual basis.

Test kit shall be stored away from direct sunlight, moisture and heat. Test kit shall not be frozen.
  • Store between 2°C to 30°C (35.6°F to 86°F)
  • Testing area temperature shall be between 15°C to 30°C (59°F to 86°F)
Test controls are separate from test kits and shall be stored in upright position in refrigerator until expiry date or for up to one year between 2°C to 8°C (36°F to 46°F).

Authorized personnel shall check expiration date of test kit prior to use.

Perform external quality control using INSTI Controls under the following circumstances:
  • With each new batch of INSTI
  • When switching to a new lot number of INSTI test kits
  • For new INSTI operator verification prior to performing testing on client specimens
  • When a new shipment of kit is received
  • when temperature during storage of the kit falls outside of 15°C to 30°C (59°F to 86°F)
  • when the temperature of the test area falls outside of 15°C to 30°C (59°F to 86°F)
Opened or expired test kit shall not be used.

Membrane unit shall be used immediately after pouch is opened.

Test samples shall be processed immediately and within 5 minutes after collection.

Used test kit shall be discarded properly.

Authorized personnel who perform and interpret test result shall also document result in IBHIS.
 
IV.  PROCEDURES
 
V.  AUTHORITY
 
DMH Directive
 
VI.  ATTACHMENTS