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40pcs 20pcs/Box Syphilis Rapid Test Kit For Whole Blood Serum Plasma

Basic Information
Place of Origin: China
Brand Name: Dewei
Certification: ISO
Model Number: SYP
Minimum Order Quantity: 10000pcs
Price: $0.1-0.20/pcs
Packaging Details: 25tests/box 20test/box
Delivery Time: 5-20 days
Payment Terms: T/T, Western Union, MoneyGram
Supply Ability: 100000pcs/day
Detail Information
Component: Rapid Test Cassette + Buffer Result Time: 15mins After Operation
Package: 25pcs/box, 20pcs/box Storage: Room Temperature 4-30℃
Sample: Whole Blood/Serum/Plasma Principle: Immunochromatography
High Light:

Syphilis Rapid Test Kit

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20pcs Rapid Test Kit

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Whole Blood Serum Plasma Test Cassette


Product Description

Syphilis Rapid Diagnostic Test Device Strip Cassette For Whole Blood Serum Plasma

INTENDED USE

The Syphilis Rapid Test is a rapid visual immunoassay for the qualitative, presumptive detection of IgM and IgG antibodies to Treponema Pallidum (TP) in human serum or plasma specimens. This kit is intended for use as an aid in the diagnosis of syphilis.

 

INTRODUCTION

Treponema Pallidum (TP), a spirochete bacterium with an outer envelope and a cytoplasmic membrane, is the causative agent of the venereal disease syphilis. Although syphilis rates are declining in the United States after an epidemic between 1986 and 1990, the incidence of syphilis in Europe has increased since 1992, especially in the countries of the Russia Federation, where peaks of 263 cases per 100,000 have been reported. In addition, the positive rate of serological test results for syphilis in HIV-infected individuals has been rising recently.

The serological detection of specific antibodies to TP has been long recognized in the diagnosis of syphilis since the natural course of the infection is characterized by periods without clinical manifestations. The antibody response to TP can be detected within 4 to 7 days after the syphilis chancre appears, allowing early detection and diagnosis of syphilis infection.

A variety of antigens have been used in syphilis serological tests, such as Rapid Plasma Cardiolipin (RPR) or VDRL antigen, TP extracts derived from in vitro culture or inoculated rabbit testes. However, RPR and VDRL antigens are not treponemal specific, and whole TP extracts are not reproducible and contain a certain amount of contaminating materials such as flagella, which may lead to a nonspecific reaction in assays of test serum.

 

PRINCIPLE

The Syphilis Rapid Test detects IgM and IgG antibodies to Treponema Pallidum (TP) through visual interpretation of color development on the internal strip. Specific recombinant TP antigens are immobilized on the test region of the membrane. During testing, the specimen reacts with recombinant TP-specific antigen conjugated to colored particles and precoated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there are sufficient antibodies to Treponema Pallidum (TP) in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

 

MAIN CONTENTS

• One pouch containing a reaction test Cassette with desiccant.

• Disposable pipettes.

• Buffer.

• Instructions for use.

 

STORAGE AND STABILITY

• Store at 39~ 86 º F (4 ~ 30 º C) in the sealed pouch for 18 months.

 

PRECAUTIONS

• For in vitro diagnostic use only.

• Do not use after expiration date.

• The test Cassette should remain in the sealed pouch until use.

• The used test Cassette should be discarded according to local regulations.

 

SPECIMEN COLLECTION AND STORAGE

  • The Syphilis Rapid Test Device (Serum/Plasma) is intended for use with human serum or plasma specimens only.
  • Only clear, non-hemolyzed specimens are recommended for use with this test. Serum or plasma should be separated as soon as possible to avoid hemolysis.
  • Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C.
  • Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.
  • If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.
  • Icteric, lipemic, hemolysed, heat treated and contaminated specimens may cause erroneous results.

 

INTERPRETATION

POSITIVE: Two colored bands appear on the membrane. One band appears in the control region (C) and another band appears in the test region (T).

NEGATIVE: Only one colored band appears, in the control region (C). No apparent colored band appears in the test region (T).

INVALID: Control band fails to appear. Results from any test which has not produced a control band at the specified read time must be discarded. Please review the procedure and repeat with a new test. If the problem persists, discontinue using the kit immediately and contact your local distributor.

 

 

Contact Details
Sherry

Phone Number : +8613316305166

WhatsApp : +008615267039708