Home Use Rapid Diagnostic For Treponema Pallidum Syphilis IVD In Serum/Plasma/Whole Blood

Treponema Pallidum(TP) Rapid Diagnostic Kit (Colloidal Gold)

For the qualitative detection of Syphilis antibodies in serum/plasma and whole blood

Main Features

☀ High Sensitivity: 100%
☀ Specificity: 100%
☀ Reliable: Accuracy higher than 97.5%, early detection of the presence of TP Antibody
☀ Convenient: Room Temperature Storage, Built-In Control
☀ Simple: No Instrument Required
☀ Fast: Results in 5-30 minutes, strong positive results may be observed promptly within 3 minutes
☀ Certified by Authoritative Certification System and Standards
☀ Winner of "the National Rapid Diagnostic Kit for Clinical Performance Assessment"



Intended Use

The Syphilis Rapid Diagnostic Test is a qualitative test for the detection of antibodies to Syphilis in human serum/plasma and whole blood. It is considered as an initial screening test for Syphilis antibodies. All positive specimens must be confirmed with Western Blot or other qualified EIA.

Principle

Syphilis Rapid Diagnostic Test is a chromatographic immunoassay (CIA) for the detection of antibodies to Syphilis in human serum or plasma. Syphilis specific antigens are precoated onto membrane as a capture reagent on the test region.

During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with Syphilis specific antigens. Antibodies to Syphilis, if present, a red colored band will develop on the membrane in proportion to the amount of Syphilis antibodies present in the specimen.

Absence of this red colored band in the test region suggests a negative result. To serve as a procedural control, a red colored band in the control region will always appear regardless the presence of antibodies to Syphilis. The RDT is simple, rapid, sensitive and specific.



Reagents and Materials Provided

☀ Blood diluent in a dropper bottle.
☀ One sealed pouched cassette with desiccant & a disposable pipe.
☀ One piece of operating instruction with 40 test pouches.

Sample Collection and Preparation

Whole Blood ( Finger stick Specimens)

☀ Clean the area to be lanced with an alcohol swab.
☀ Squeeze the end of the fingertip and pierce it with a sterile lancet.
☀ Wipe away the first drop of blood with sterile gauze or cotton.
☀ Allow the second drop to flow directly into a sample well.

Plasma
☀ Have a certified phlebotomist collect whole blood into a purple, blue or green top collection tube (containing EDTA, citrate or heparin, respectively) by veinpuncture.
☀ Separate the plasma by centrifugation.
☀ Carefully withdraw the plasma for testing or label and store it at 4°C for up to five days. Plasma may be frozen at -20°C for at least three months.

Serum

☀ Have a certified phlebotomist collect whole blood into a red top collection tube (containing no anticoagulants) by veinpuncture.

☀ Allow the blood to clot.

☀ Separate the serum by centrifugation.

☀ Carefully withdraw the serum for testing or label and store it at 4°C for up to five days. Serum may be frozen at -20°C for at least three months.

Assay Procedure

Serum or Plasma Sample

Add 2 drops of serum or plasma into sample well. Observe the result in 120 minutes.

Whole Blood Sample

Add 1 drop of whole blood into sample well, after all blood completely absorbed. Add 2 drop of whole blood diluent. Observe the result in 20 minutes.

Storage

Store the test kits at temperature 4-30°C,in the sealed pouch for the duration of the shelf life (24 months).

Interpretation of Results

Negative:
No apparent band in the test region (T), Only one red band appears in the control region (C). This indicates that no TP antibodies have been detected.
Positive:
In addition to one red band in the control region (C), a red band will appear in the test region (T). This indicates that the specimen contains TP antibodies.
Invalid:
If no band appears in the control region(C), regardless of the presence or absence of band in the test region (T). It indicates a possible error in performing the test. The test should be repeated using a new device.

Limitation

1. This Rapid Test is a qualitative test for the detection of anti-Tp antibody in human serum or plasma. The intensity of the test band does not correlate with the antibody concentration in the specimen.

2. A negative result for an individual subject indicates absence of detectable anti-Tp antibodies . However, a negative test result does not preclude the possibility of exposure to or infection with Tp.

3. A negative result can occur if the quantity of the anti-Tp antibody present in the specimen is below the detection limits of the assay, or the antibodies that are detected are not present during the stage of disease in which a sample is collected.

Newscen Biopharm Co., Limited is a professional manufacturer of in vitro diagnostic products and related supporting apparatuses, which is jointly founded by Tianjin Pharmaceutical Group, Tianjin Zhongxin Pharmaceuticals Co., Ltd and oversea Chinese entrepreneurs.

Founded in 2003, the company is one national high tech corporation and Tianjin Grade A medical device manufacturer. Over the years, the company has been committed to the research, development, production and sales of in vitro diagnostic products and related supporting apparatuses, and also has provided OEM and ODM and technology transfer and cooperation as well as some other customer market based diversified services to customers at home and abroad.

NewScen is based on independent innovation and relies on the talent sharing at home and abroad, information interaction advantage, antibody preparation and new product R & D technology platform to develop and produce nine series about one hundred kinds of products including tests and instruments and put on the market in succession.

HIV (1 + 2) antibody rapid test Kit and other IVD (In Vitro Diagnostic) devices obtained National Patent and National Class of New Drug Certificate; HCV Antibody Rapid Test is the first double antigen sandwich test HCV patented product; NewScen’s quantitative test broke through the technical difficulty of the colloid gold quantitative detection, opening up a new situation for clinical application of Colloidal Gold test. Rapid immuno assay reader provides an open and common platform for qualitative and quantitative detection of the Colloidal Gold test.

The company has received CFDA medical device certificates of 32 products, 49 independent Intellectual Property Rights, FDA certificates of series of products and European CE certificates of 16 products. Production management is in strict accordance with the regulations of in vitro diagnostic product production as well as international quality management system (ISO 9001, ISO 13485) so as to ensure high product quality. Products are sold throughout the country and in North America, South America, Southeast Asia, Europe, the Middle East, Africa and other international markets.

Currently, the company integrated Colloidal Gold test, immunochromatographic interpretoscope and cloud technology and other technical advantages, and created management integrated POCT system, so as to achieve convenient, accurate and efficient onsite data collection and remote guidance or data sharing of the monitoring center and promote the development of modern testing technique and the improvement of diagnosis and treatment level.

NewScen has obtained the project support from Tianjin or the country for nine times in succession, has been identified as one Hightech Enterprise in Tianjin, has obtained the title of “Top 100 Enterprise in Tianjin” among Tianjin SMEs, and is the rapid diagnostic Hightech demonstration project base and National 863 Project undertaker awarded by the NDRC (National Development and Reform Commission).

Fecal Occult Blood, Serum Ferritin and Hepatitis C rapid test products were named Tianjin independent innovation products; brand “YBT”products have been awarded the title of “Chinese Women and Children Favorite Brand Product” by Chinese Women and Children Development Center; “YBT” trademark was named “Tianjin Famous Trademark”.

“Honesty, Verity, Authenticity, and Innovation", is our persistent commitment.

“Encouraging Our Employees Growing With Company” is the driving force beneath our surging growth.