Description
The Chembio HIV 1/2 STAT-PAK Assay is an FDA approved, CLIA waived lateral flow test that screens for HIV 1 and HIV 2 antibodies from a 5 microliter sample. Results develop in 15 minutes on a simple cassette with a built-in procedural control. The format asks little of the operator and nothing of the bench, which is why it has stayed a workhorse of outreach and clinic screening.
- 5 microliter sample – A single small drop feeds the cassette, keeping collection fast and low burden
- Results in 15 minutes – Screening completes inside one visit, with no batching and no instrument queue
- Lateral flow simplicity – The cassette workflow is three steps: prepare, run and read
- Room temperature storage – Kits store at 8 to 30 degrees Celsius with a 24 month shelf life
About This Lateral Flow HIV Test
Chembio Diagnostic Systems catalogues this lateral flow assay as item 60-9505-1 with 20 tests in each kit. The manufacturer publishes sensitivity of 99.7 percent and specificity of 99.9 percent for the platform, figures that have made it a reference point among visually read rapid HIV tests. A built-in procedural control line confirms the sample migrated correctly before the operator reads the test line. A matched control pack, manufacturer item 60-9549-0, supports external quality control runs for programs that document them. For sites that want a visually read test with the shortest possible training curve, this cassette remains the straightforward choice in the line.
Features and Benefits
Testing Performance
- Sensitivity 99.7 percent – Manufacturer published sensitivity for the lateral flow platform
- Specificity 99.9 percent – Manufacturer published specificity supports confident screening programs
- Built-in procedural control – The control line verifies flow on every cassette before results are read
Workflow and Handling
- No instrument required – Results are read by eye on the cassette window at 15 minutes
- Small sample volume – Five microliters is enough, which suits fingerstick collection in the field
- Ambient storage range – Storage at 8 to 30 degrees Celsius avoids refrigerated inventory for most sites
Product Specifications
Assay Details
- Product: HIV 1/2 STAT-PAK Assay, lateral flow rapid test
- Manufacturer Part Number: 60-9505-1
- Analytes: Antibodies to HIV type 1 and HIV type 2
- Sample Volume: 5 microliters
- Result Time: 15 minutes
- Storage: 8 to 30 degrees Celsius
- Shelf Life: 24 months
- Regulatory: FDA approved, CLIA waived
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 Lateral Flow HIV Test
Some screening sites need reader-based objectivity, and others need a cassette that any trained counselor can run from a folding table. This is the second kind of test, built by the same manufacturer as the reader-based line, with published performance that matches far more complicated platforms. Programs standardize on it when training time is scarce and session volume is not.
- Runs anywhere – No reader, no power and no bench setup stand between the kit and a screening session
- Fast staff onboarding – The three step lateral flow workflow is taught in minutes and audited at a glance
- Published performance – Sensitivity of 99.7 percent and specificity of 99.9 percent come straight from the manufacturer
Frequently Asked Questions
What does this assay detect?
It detects antibodies to HIV type 1 and HIV type 2 on a lateral flow cassette. Reactive screening results are confirmed under the testing program protocol.
How much sample does it need?
Each test uses a 5 microliter sample. Results develop in 15 minutes and are read on the cassette window.
Does it need a reader instrument?
No. This assay is read visually, and a built-in procedural control line confirms each run. Reader-based testing in this catalog is the DPP line.
How should kits be stored?
The manufacturer directs storage at 8 to 30 degrees Celsius, and kits carry a 24 month shelf life. Most sites keep them at ordinary room temperature.
What exactly ships when I order?
You receive one kit of 20 tests under manufacturer part number 60-9505-1. A matched external control pack is catalogued by the manufacturer as item 60-9549-0.
Who typically uses this test?
Outreach teams, clinics and community programs use it for rapid HIV screening where a simple visually read cassette fits the setting. It is FDA approved and CLIA waived for professional use.
