The DETERMINE™ HIV Early Detect is a groundbreaking diagnostic tool that sets new standards in HIV screening by offering enhanced capabilities for early detection. Unlike traditional tests that primarily detect antibodies, this device is designed to identify both the HIV-1 p24 antigen (which appears earlier in the infection) and antibodies to HIV-1 and HIV-2, including a wide range of HIV subtypes and recombinant forms. This dual detection mechanism allows for diagnosis during the crucial early, acute phase of infection, thereby significantly shortening the “window period” and opening new possibilities in patient care.

Key Features and Benefits:

• Unrivaled Early Detection: By detecting both p24 antigen and antibodies, the DETERMINE™ HIV Early Detect enables diagnosis during the acute infection phase, allowing for earlier intervention and care compared to third and fourth-generation antibody-only tests.
• Exceptional Performance: The test boasts a perfect sensitivity of 100% and a high specificity of 99.72%, ensuring highly reliable results.
• Broad Subtype Coverage: It is capable of detecting a wide array of HIV-1 group M antigens (including subtypes A, B, C, D, F, G, H, J, K, CRF01-AE, CRF02-AG) and Group O antigens, as well as HIV-1 antibodies (groups M, O, P, N, and recombinant forms) and HIV-2 antibodies. This versatility is crucial for effectively addressing diverse diagnostic demands globally.
• Rapid Results: Provides accurate and actionable results within 20 minutes, facilitating prompt clinical decisions and linkage to care.
• Versatile Sample Compatibility: The test can be performed using various human specimens, including whole blood (fingerstick or venipuncture), serum, or plasma, requiring only a small sample volume of 50 µL.
• User-Friendly Design: The testing procedure is simple and straightforward, requiring no complex equipment or calculations, making it suitable for diverse clinical environments.
• Optimal Storage and Shelf Life: The device remains stable when stored between 2°C and 30°C and has an extended shelf life of 18 months.
• Compact Packaging: Its lightweight and compact design supports efficient storage and transportation, helping to reduce costs and minimize environmental impact.
• Kit Contents: Each kit contains supplies for 20 tests.

Testing Procedure Overview (Simplified):

1. Prepare the Test: Open the sealed pouch and place the test strip on a clean, flat surface.
2. Add Sample: Apply the specified volume of sample (serum, plasma, or whole blood) to the test pad. If using whole blood, follow by adding the buffer solution.
3. Read Results: Allow the test to develop for 20 minutes. Interpret the results by observing the colored lines that appear. A visible control line indicates a valid test.

The DETERMINE™ HIV Early Detect is an essential tool for healthcare providers committed to advancing HIV diagnosis and management, offering a fast, accurate, and accessible solution to identify infections earlier and connect individuals to vital care services.