Infectious Disease
Syphilis Rapid Test
Detects Treponema pallidum antibodies. colloidal-gold. Specimen: WB / S / P.
| Target / Analyte | Treponema pallidum antibodies |
|---|---|
| Disease / Indication | Syphilis |
| Series | Infectious Disease |
| Method | colloidal-gold |
| Specimen | WB / S / P |
| Regulatory | CE |
| OEM/ODM | Available — private label & custom panel |
Direct Answer
This rapid test detects Treponema pallidum antibodies in WB / S / P to support Syphilis. It is a colloidal-gold screening test — a reactive result is presumptive and should be confirmed per the intended use.
Intended Use
Detection of Treponema pallidum antibodies for syphilis screening.
Clinical Context
Treponemal antibody tests detect immune response to T. pallidum. Used in antenatal and blood-donor screening and STD programs.
Test Principle
Colloidal-gold immunochromatography (lateral flow). The device captures the target analyte (antigen or antibody) on a membrane via labeled antibodies, producing a visible test line within minutes. Qualitative or semi-quantitative, intended as a screening/triage aid — not a replacement for confirmatory laboratory testing.
Limitations
Treponemal tests remain positive after treated infection — cannot distinguish active from past; confirm with non-treponemal (RPR) titer.
Procurement
Specimen: whole blood / serum / plasma. Format: cassette / dipstick. CE-marked line.
Interpretation
| Result | Lines | Meaning |
|---|---|---|
| Positive | Test + control line | Target detected (presumptive positive) |
| Negative | Control line only | Below cut-off / not detected |
| Invalid | No control line | Repeat with a new device |
Available SKUs (this series)
| Cat. No. | Product | Specimen | Format | Kit Size | Status |
|---|---|---|---|---|---|
| ISY-301 | Syphilis Rapid Test Dipstick - 3.0 +1 variants | S / P | Dipstick | 50 T | CE |
| ISY-302 | Syphilis Rapid Test Cassette | S / P | Cassette | 40 T | CE |
| ISY-401 | Syphilis Rapid Test Dipstick - 2.5 +2 variants | WB / S/ P | Dipstick | 50 T | CE |
| ISY-402 | Syphilis Rapid Test Cassette | WB/S/P | Cassette | 40 T | CE |
| IMID-325 | Syphilis/HIV1.2 Combo Rapid Test Cassette | S / P | Cassette | 25 T | Non-CE |
| IISC-325 | Syphilis/HIV1.2.O Combo Rapid Test Cassette | S/P | Cassette | 25 T | Non-CE |
| IISC-425 | Syphilis/HIV1.2.O Combo Rapid Test Cassette | WB/S/P | Cassette | 25 T | Non-CE |
| IISC-402 | HIV1.2 and Syphilis(in one strip) Combo Rapid Test Cassette +1 variants | WB/S/P | Cassette | 40 T | Non-CE |
| IMID-345 | HBsAg /HCV /HIV /Syphilis Combo Rapid Test Cassette | S / P | Cassette | 25 T | Non-CE |
| IMID-445 | HBsAg /HCV /HIV /Syphilis Combo Rapid Test Cassette | WB/S / P | Cassette | 25 T | Non-CE |
Documentation & quotation — datasheet, IFU, MOQ and OEM/ODM options on request.
Last reviewed: 2026-09-12