Test name : HIV 1/2 3.0
Brand : BIOLINE™ (03FK17)
Procurement Method : Direct Purchase
Used since :
Clinical application : The kits are designed for the qualitative detection of antibodies of all isotypes (IgG, IgM, IgA) specific to HIV-1 and HIV-2 simultaneously in whole blood, serum, or plasma. They are intended for use as an initial screening test to aid in diagnosis. Reactive specimens should be followed up with a confirmatory test.
Quick Reference Guide:
PENDING
All HQE staff assigned to perform, or who wish to become operators of, HIV testing must:
Complete the self-directed online training, which includes:
reviewing in full:
the SOP & Quick Reference Guide and
the Instructions for Use (Product Insert).
and watching the tutorial video.
Successfully pass the theoretical competency assessment below with a score of 100%.
Training and competency assessment must be completed before using the device and every 2 years thereafter for recertification. It must also be repeated earlier if any of the following occur:
Changes to the test kit
Any critical error is identified
NOTE : Please use your personal MOH email to complete the assessment.
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Internal procedural controls are included in the test. A colored band appearing in the control region (C) is considered an internal positive procedural control, confirming diluent has been applied successfully and that the active ingredients of main components on the strip are functional, but is not a guarantee that the specimen has been properly applied and does not represent a positive specimen control.
If the control line fails to appear, the test is considered invalid and results should not be reported. If this occurs, the test should be repeated with a new kit. If the problem persists, discontinue using the kit immediately and contact our POCT Support Staff.
External quality control using positive and negative controls are performed at the laboratory every time a new box of kit is opened. Upon observing the expected results, the kit is ready to be supplied to POC facilities and is ready for use.
Related Documents
Old kits