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syphilis rapid test

🧪 Sirin Diagnostics – Syphilis Rapid Test Device (Whole Blood/Serum/Plasma)

For Professional In Vitro Diagnostic Use Only

 

📌 Intended Use

A rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to Treponema Pallidum (TP) in whole blood, serum, or plasma, to aid in the diagnosis of syphilis.

💡 Principle

Utilizes double antigen sandwich technology with TP antigens coated on particles and membrane.

Detects both IgG and IgM antibodies.

Visual results within 10 minutes:

 

Positive: Two lines (C and T)

 

Negative: One line (C only)

 

Invalid: No control line (C)

 

🧾 Performance

 

Relative Sensitivity: 99.5%

 

Relative Specificity: 99.3%

 

Overall Accuracy: 99.4%

 

Validated against a leading TPHA Syphilis test.

 

📦 Kit Contents

 

Test devices (sealed pouches)

 

Buffer

 

Droppers

 

Package insert

 

🧪 Specimen Type

 

Whole Blood (venipuncture or fingerstick)

 

Serum

 

Plasma

 

📋 Storage

 

2°C – 30°C (Do not freeze)

 

Stable until expiration date printed on pouch

 

⚠️ Precautions

 

Professional use only

 

Do not use after expiration or if pouch is damaged

 

Handle all specimens as potentially infectious

 

Wear gloves, lab coat, and eye protection

 

Dispose of used tests according to local regulations

 

Features & Benefits

 

Rapid results in 10 minutes

 

High accuracy and reliability

 

Works with whole blood, serum, or plasma

 

No additional equipment required

 

how to use