What specimen is required for the test?

The test requires a fingertip blood sample for detection of Treponema pallidum antibodies.

Is the test suitable for children?

For users aged 13-18 years, the test should be conducted by a parent or legal guardian.

What does a positive result mean?

A positive result means you have antibodies that may be from a Syphilis infection. You will need another test to confirm whether you actually have Syphilis.

One Step Pharmacy Blood Diagnosis Syphilis Antibody Test Device for Self Test

Name: One Step Pharmacy Blood Diagnosis Syphilis Antibody Test Device for Self Test
Brand: Henan Season Medical Device Co., Ltd.
SKU: 2111097842

Henan, ChinaHenan Season Medical Device Co., Ltd.

US$1.50

1,000-9,999 Pieces

US$1.40

10,000-99,999 Pieces

US$1.20

100,000+ Pieces

Sample price:US$0.00/piece.Request sample

Product profile

Customization

Available

Type

IVD Reagent

Product Name

Syphilis Self Test

Model NO.

SY-048

Sensitivity

99.9%

Accuarcy

99.9%

Specimen

Fingertip Blood

Shelf Life

24 Months

Usage

Home Use

Transport Package

Carton

Specification

Cassette

Trademark

Origin

China

HS Code

3822190090

Production Capacity

300000PCS/Day

Key features

High Sensitivity: 99.9% sensitivity for accurate detection of Syphilis antibodies.

High Accuracy: 99.9% accuracy ensures reliable preliminary screening results.

Quick Results: Get results in just 5 minutes with easy operation.

Home Use Friendly: Designed for convenient self-testing at home or in pharmacies.

CE & IVDR Certified: Meets IVDR, CE, and ISO standards for quality assurance.

Fingertip Blood Sample: Requires only a small drop of fingertip blood for testing.

Cassette Format: Convenient cassette design for easy handling and reading.

Company profile

Henan Season Medical Device Co., Ltd.

Henan, China

Business Type: Manufacturer/FactoryExport Year: 2005-08-05Nearest Port: Shanghai, TIANJINAverage Response Time: ≤5.91hTerms of Payment: T/T, PayPal, Western Union, etc.International Commercial Terms(Incoterms): FOB, EXW, CFR, CIF, DDP, DAP, FCA

AI-Powered supplier vetting

SummaryHenan Season Medical Device Co., Ltd. is identified as a Chinese manufacturer/factory specializing in point-of-care and in-vitro diagnostic self-testing products. The supplier reports eight production lines, annual Early Pregnancy HCG test output of 10,000,000 pieces, and lead times of within 15 working days in both peak and off-peak seasons. Its stated export coverage is broad, with exports accounting for 90% of total sales. ISO 9001, ISO 13485, ISO 14001, and CE/FDA-related approvals are reported. Evidence also indicates OEM packaging, R&D engineers, and quality-control staff. However, the provided information does not sufficiently establish after-sales service processes, financial credibility, or verified customer case depth. Trade data shows only one transaction, which is insufficient to demonstrate an established customer track record.

Supplier typeThe supplier is explicitly identified as a Manufacturer/Factory and Limited Company based in Zhengzhou, Henan, China. Its stated business focuses on biomedical IVD and rapid self-testing products, indicating direct manufacturing involvement rather than only trading activity.

CertificationsThe supplier reports ISO 9001, ISO 13485, and ISO 14001 certifications or approvals, and states that its products have received CE approval in Europe and FDA approval in the United States. These claims provide explicit evidence of a certification and regulatory-compliance capability, although the slices do not provide certificate numbers, validity dates, or scope details.

R&D capabilityThe supplier reports 6–10 years of R&D engineer experience and offers a broad range of rapid and self-testing products, including digital pregnancy and ovulation tests, vitamin D, UTI, syphilis, and drug tests. This supports product-development capability, although no specific patents, new-product launches, or measurable innovation outcomes are provided.

Production capacityThe supplier reports eight production lines, annual Early Pregnancy HCG test output of 10,000,000 pieces, and order fulfillment within 15 working days during both peak and off-peak seasons. Its export sales share is reported as 90%, indicating stated production and international fulfillment experience.

Customization capabilityThe supplier explicitly offers OEM packaging and states that it provides customer-specific solutions and configurations. This supports packaging-level customization, but the slices do not confirm broader customization such as formulation, tooling, labeling compliance, or product design changes.

Product Q&A

Q:What is Syphilis?

Syphilis is a sexually transmitted infection (STI) caused by the bacterium Treponema pallidum subspecies pallidum that can lead to serious health problems if untreated. Symptoms vary by stage: primary, secondary, latent, or tertiary.

Q:How is Syphilis transmitted?

Syphilis is usually passed on through vaginal, anal, or oral sex without a condom. It can also be transmitted through direct contact with skin or tissues of an infected person. Pregnant women can pass it to their baby.

Q:What are the symptoms of Syphilis?

Many people have no noticeable symptoms. Primary stage includes a red lump or sore (chancre) and swollen glands. Secondary stage may cause a rash, flu-like illness, mouth sores, and hair loss. Tertiary stage can damage the heart, brain, and nervous system.

Q:Why do I need a Syphilis home test?

Early detection is crucial to prevent irreversible damage, especially in later stages. The self-test is quick (5 minutes), easy to operate, and allows you to screen at home anytime as an auxiliary tool.

Q:How long does the test take?

The test takes only 5 minutes to complete and provides quick, easy-to-read results.