Description
The Chembio DPP HIV 1/2 Assay is an FDA approved, CLIA waived rapid test that detects antibodies to HIV 1 and HIV 2 from a small 10 microliter sample. It runs on oral fluid, fingerstick or venous whole blood, serum or plasma, so one kit covers the specimen types a testing program actually collects. A built-in procedural control confirms each run, and the closed SampleTainer sample system keeps handling simple for the operator.
- Five specimen types – Oral fluid, fingerstick whole blood, venous whole blood, serum and plasma all run on the same cassette format
- 10 microliter sample – A small sample volume keeps collection quick and tolerable for the person being tested
- Built-in procedural control – Every cassette carries its own control, so a valid run is confirmed on the device itself
- 23 month shelf life – Long dating supports stocked testing sites that run sessions on a schedule rather than daily
About This Rapid HIV Antibody Test
This assay belongs to the Dual Path Platform family built by Chembio Diagnostic Systems of Medford, New York, and it is catalogued by the manufacturer as item 65-9500-0 with 20 tests in each kit. The cassette separates the sample path from the buffer path, which is the design behind the platform name and part of why results stay consistent across specimen types. Published performance from the manufacturer reports sensitivity from 98.9 to 99.9 percent and specificity from 99.9 to 100 percent depending on the specimen tested. The SampleTainer closed vial system meters the sample before it reaches the cassette, cutting down on spills and repeat collections during busy screening sessions. For clinics, community testing programs and hospital laboratories, the kit offers confirmatory-grade screening workflow in a waived format that trained staff can run at the point of care.
Features and Benefits
Testing Performance
- Sensitivity 98.9 to 99.9 percent – Manufacturer published figures across the five accepted specimen types
- Specificity 99.9 to 100 percent – Published specificity reaches 100 percent on fingerstick whole blood
- Dual path platform – Separate sample and buffer paths support consistent migration and readable results
Workflow and Handling
- CLIA waived complexity – The waived categorization suits point of care sites operating under a CLIA certificate of waiver
- SampleTainer closed system – Samples are collected and metered in a closed vial before cassette application
- Five specimen options – Programs can test oral fluid when blood collection is impractical and switch to blood when it is preferred
Product Specifications
Assay Details
- Product: DPP HIV 1/2 Assay rapid antibody test
- Manufacturer Part Number: 65-9500-0
- Analytes: Antibodies to HIV type 1 and HIV type 2
- Specimen Types: Oral fluid, fingerstick whole blood, venous whole blood, serum, plasma
- Sample Volume: 10 microliters
- Regulatory: FDA approved, CLIA waived
- Shelf Life: 23 months
Packaging
- Package: Kit of 20 tests
Browse the full testing range in See all Diagnostic Test Kits, or head to Shop more Chembio Diagnostics Products for the rest of the brand catalog.
Why Choose This Rapid HIV Antibody Test
Many rapid HIV tests force a program to choose between specimen flexibility and published performance, and this platform does not. The dual path design, the closed sample vial and the five accepted specimen types come from one manufacturer with one catalog number, so reorders match the validated kit exactly. That traceability is what quality officers ask for when a screening program is audited.
- Fewer failed collections – Oral fluid collection keeps sessions moving when fingerstick sampling is refused or impractical
- Audit-ready sourcing – One manufacturer, one part number and published performance data simplify program documentation
- Waived-site friendly – The CLIA waived format fits community and clinic sites that cannot run moderate complexity testing
Frequently Asked Questions
What does this assay detect?
It detects antibodies to HIV type 1 and HIV type 2. A reactive result is a screening result that the testing program confirms under its own protocol and current guidelines.
Which specimens can be tested?
The manufacturer validates oral fluid, fingerstick whole blood, venous whole blood, serum and plasma. Each kit run uses a 10 microliter sample of the chosen specimen type.
Is the test CLIA waived?
Yes. The manufacturer lists the assay as FDA approved and CLIA waived, which suits point of care testing under a certificate of waiver.
How are results read?
Results develop on the cassette window, and a built-in procedural control line confirms that the run performed correctly. Staff read the test and control lines at the directed time in the product insert.
What exactly ships when I order?
You receive one kit of 20 tests under manufacturer part number 65-9500-0, exactly as catalogued by Chembio Diagnostic Systems. The kit has a 23 month shelf life from manufacture.
Who typically uses this test?
Clinics, community screening programs, public health departments and hospital laboratories use it for rapid HIV screening at the point of care. It is built for professional use by trained testing staff.
