ISN Medical

Determine™ HIV Early Detect | ISN Medical

Determine™ HIV Early Detect

The Determine™ HIV Early Detect is a visually read, qualitative immunoassay designed for the detection of antibodies (Ab) to HIV-1 and HIV-2 as well as non-immunocomplexed (free) HIV-1 p24 antigen (Ag) in human capillary and venous whole blood, plasma, or serum.

Key Features 

  • Detects acute infections earlier – helps increase case finding and supports faster diagnosis
  • Rapid results – accurate results available in just 20 minutes
  • Helps get patient to the right care, enabling timely treatment initiation
  • Broad detection range – robust to major known circulating HIV subtypes
  • Easy to use – minimal training required, no need for expensive lab equipment
  • Sensitivity: 100%
  • Specificity: 99.72%
  • Shelf life: 18 months
  • Storage conditions: 2-30° C
  • Sample volume: 50 µL

How to Use 

1.   Prepare Test: Tear one strip from the right and remove the cover

2.  Place Test: Place one strip on a flat surface where the test is to be performed

3.  Add Sample (Fingerstick Whole Blood): Add 50 µL of whole blood to the Sample Pad. When all the blood is transferred from the capillary tube to the Sample Pad, immediately apply one drop of chase buffer to the Sample Pad.

  • Venipuncture Whole Blood: Add 50 µL of whole blood (precision pipette) to the Sample Pad. Wait 1 minute and add one drop of Chase Buffer.

  • Serum or Plasma: Add 50 µL of serum or plasma (precision pipette) to the Sample Pad.

4.  Read Results: Read the test result between 20 and 40 minutes after the addition of the sample. Do not read the test result after 40 minutes and before 20 minutes. The control line should appear for all results. If it does not appear, the results are invalid and should be repeated using a new test strip.

Determine HIV Early Detect is the 1st and only WHO pre-qualified 4th generation rapid diagnostic testing that sets a new standard in HIV point of Care testing, with exceptional dual accuracy on the HIV antigen and antibody sensitivity.

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