Instruction for Use Video
Fighting the Syphilis and HIV Epidemics: Voices from the Field – NCSD Webinar
DPP® HIV-Syphilis Assay
MDA Registration number: IVDD4417977617
CE-Marked
FDA Approved
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Patented DPP® technology allows for higher sensitivity and specificity
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2 test results in a single sample
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Small sample volume: 10 μl
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DPP sample tainer included for safe and closed sample handling
A dual rapid test for the detection of antibodies to HIV 1/2 and Treponema pallidum in fingerstick whole blood, venous whole blood, serum or plasma specimens.
| Platform | Immunochromatographic Assay |
| Format | Cassette |
| Detection | HIV-1 and HIV-2 antibodies |
| Specimen | Whole blood, serum & plasma |
| Assay Time | 15 minutes |
| Shelf Life* | 24 months |
*From date of manufacture
|
Infection |
Performance |
Fingerstick |
Venous |
Plasma |
Serum |
|---|---|---|---|---|---|
|
HIV |
Sensitivity |
99.9% |
100% |
100% |
100% |
|
Specificity |
100% |
99.9% |
99.9% |
99.9% |
|
|
Syphilis |
Sensitivity |
N/A |
N/A |
N/A |
99.1% |
|
Specificity |
N/A |
100% |
N/A |
100% |
|
Cat. No. |
Product Description |
Test Specimen |
Product Format |
Intended Use |
Intended Use |
Storage Temp. |
Packing Size |
|---|---|---|---|---|---|---|---|
|
60-9525-0 |
DPP® HIV-Syphilis Assay |
WB/S/P |
Cassette |
Detection of antibodies of HIV Type 1 and 2 and/or Treponema pallidum bacteria (causative agent of syphilis) |
For Professional Use |
2-30°C |
20 T/ Kit |
Chembio’s proprietary DPP® technology differs from classical lateral flow tests by operating in a manner similar to that of the sequential ELISA format which is not sensitive to the “Hook Effect”.
DPP® Technological Advantages:
- Enhanced multiplex capability up to 8 biomarkers with results in minutes
- Significantly increased analytical and clinical sensitivity
- Ability to effectively resolve normal aggregation/agglutination migratory issues, a common concern in lateral flow assays with large particle analytes (e.g., bacteria)
- Adaptable to multiple sample types such as fingerstick blood, oral fluid, venous whole blood, serum and plasma
