Product Description:
| Product Name |
Syphilis (Tp) Ab Rapid Test (Whole Blood/Serum/Plasma) |
| Test Type |
Lateral flow immunochromatographic assay |
| Detection |
Antibodies (IgG, IgM, and IgA) to Treponema pallidum (Tp) |
| Sample Types |
Human whole blood, serum, or plasma |
| Purpose |
Screening test and aid in diagnosis of syphilis infection |
| Usage |
Professional use only |
| Interpretation |
Results must be interpreted along with other clinical information or diagnostic methods |
| Pathogen Details |
Treponema pallidum (Tp) subspecies pallidum: Gram-negative, spiral-shaped, highly mobile bacterium |
| Infection Statistics |
Estimated 12 million cases globally in 1999, with >90% in developing regions |
| Serological Detection |
IgM and IgG are key markers; IgM appears ~2 weeks post-infection, IgG at ~4 weeks, lasting years or decades |
| Test Features |
Measures antibodies (IgM, IgG, IgA) using recombinant Tp antigens, high sensitivity and specificity, no additional instruments needed |
Features:
- Product Name: SYP (Tp) Ab Rapid Test
- Application: Clinical/ Hospital/ Laboratory/ Home
- Reading Time: 5-15 Minutes
- Type: Colloidal Gold
- Shelf Life: 24 Months
Technical Parameters:
| Product Name |
SYP (Tp) Ab Rapid Test
|
| Package |
25/50/100 Tests/kit |
| Sample Type |
WB/S/P |
| Shelf Life |
24 Months |
| Type |
Colloidal Gold |
| Reading Time |
5-15 Minutes |
| Format |
Cassette/Strip |
| Application |
Clinical/ Hospital/ Laboratory/ Home |
| Detection Limit |
High Sensitivity |
| Test Method |
Rapid Test |
This Colloidal Gold Rapid Test is suitable for clinical, hospital, and laboratory use. It has a high sensitivity and can detect IgM antibodies to Adenovirus in WB/S/P samples in just 5-15 minutes. The test comes in a convenient cassette or strip format and has a long shelf life of 24 months. It is not intended for home use and is not an aids test.
Test Principle:
The Syphilis (Tp) Ab Rapid Test (Whole blood/Serum/Plasma)is a qualitative, membrane based immunoassay for the qualitative detection of antibodies including IgG, IgM, and IgA to Treponema pallidum (Tp) in human whole blood, serum or plasma.
The membrane of the test strip contained in the cassette is pre-coated with recombinant Tp antigens. During testing, the specimen is added into the sample pad and antibodies to Tp if present will react with Tp antigens coated particles in the membrane strip. The mixture then migrates upwards by capillary action on the membrane and reacts with recombinant Tp antigens on the membrane in the test line (T) region. If the specimen contains IgG, IgM, or IgA antibodies to Tp, a pink test line (T) will appear, indicating a positive result. If the specimen does not contain IgG, IgM, or IgA antibodies to Tp, the test line (T) will not appear, indicating a negative result. The test contains an internal control line (C) which should always exhibit a pink line regardless of the color in the test region. Otherwise, the test result is invalid and the specimen must be retested with a new device.
Reagents and Materials Provided:
25 X Test devices. Test cassettes are individually sealed in a foil pouch with a dropper and a package of desiccant.
1 X Assay buffer
1 X Instruction for use
Materials Required But Not Provided:
Clock or Timer
Clean containers for the collection of specimen
Lancets (for fingerstick whole blood only)
Centrifuge (for plasma only)
Heparinized capillary tubes and dispensing bulb (for fingerstick whole blood only)
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