PURPOSE OF TEST
The Chembio HIV 1/2 STAT-PAK® Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Type 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood specimens. The Chembio HIV 1/2 STAT-PAK® Assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms.
POLICY
Chembio Rapid HIV 1/2 STAT-PAK Assay
SUPPLIES
Chembio Rapid HIV 1/2 STAT-PAK Assay Test Kit Supplies
MANUFACTURER’S INFORMATION
Rapid HIV 1/2 STAT-PAK Assay Package Insert
Rapid HIV 1/2 STAT-PAK Assay Reactive/Nonreactive Controls Package Insert
IDA Pages (Clinical Indications, Documentation Plan, Clinical Actions)
INITIAL ORIENTATION, TRAINING & COMPETENCY
Initial Orientation & Training – This must be completed (once) with all new staff trained to use this test.
Manufacturer Video Training Tutorial
Competency Test – This must be completed by all testing personnel 1) After initial training and before technical duties are performed; 2) 6 months after initial training (California Law); and 3) annually after the initial competency date.
QUALITY CONTROL
SAFETY DATA SHEETS (SDS)