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
Test time	10–15 min (product-specific)
Storage	2–30 °C, sealed pouch with desiccant
Shelf life	24 months (product-specific)
Regulatory	CE (IVDD 98/79/EC)
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

Common misconception

A negative rapid test does not always exclude infection — timing, specimen and pathogen load all matter. Follow up clinically where suspicion is high.

Sources

Screening results are presumptive, not diagnostic. Confirmatory testing follows WHO, CDC and national regulatory guidance — see screening vs confirmatory.

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

Technical Evidence

Analytical performance	Sensitivity, specificity, cut-off and precision are documented per product line in the datasheet and validation report.
Average accuracy	≥96% (overall agreement rate, manufacturer-validated). Per-product sensitivity and specificity are documented in the datasheet.
Clinical performance	Evaluation data (study population, reference method, agreement) available on request.
Cross-reactivity	Documented per analyte — see limitations above.
Documents	IFU · Datasheet · Certificate · Declaration of Conformity — request below.

Buyer Information

MOQ	Product-dependent — low MOQ available on specialty assays
OEM / private label	Custom branding, cut-off, panel and packaging
Samples	Available for evaluation — request via RFQ
Lead time	On request
Documents	IFU · Datasheet · COA · Validation report · CE files · Registration support

Related knowledge

Documentation & quotation — datasheet, IFU, certificate, MOQ and OEM/ODM options on request.

Request IFU / Spec Sheet Request Datasheet Request Certificate

Last reviewed: 2026-09-12