ISO 15min Qualitative Detection Plasma Typhoid IgG IgM Rapid Test

Typhoid IgG/IgM Rapid Test

For the qualitative detection of Typhoid IgG/IgM Antibody in serum/ plasma/whole blood

Typhoid IgG/IgM Combo Rapid Diagnostic Kit High Accurate Home Use Infectious Disease Typhoid Fever

Intended Use

The Typhoid IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of anti-Salmonella typhi (S. typhi) IgG and IgM in human serum or plasma.

It is intended to be used as a screening test and as an aid in the diagnosis of infection with S. typhi. Any reactive specimen with the Typhoid IgG/IgM Rapid Test must be confirmed with alternative testing method(s).

Principle

Typhoid fever is caused by S. typhi, a Gram-negative bacterium. World-wide an estimated 17 million cases and 600,000 associated deaths occur annually. Patients who are infected with HIV are at significantly increased risk of clinical infection with S. typhi.

Evidence of H. pylori infection also presents an increase risk of acquiring typhoid fever. 1-5% of patients become chronic carrier harboring S. typhi in the gallbladder.
The clinical diagnosis of typhoid fever depends on the isolation of S. typhi from blood, bone marrow or a specific anatomic lesion. In the facilities that can not afford to perform this complicated and time-consuming procedure, Filix-Widal test is used to facilitate the diagnosis. However, many limitations lead to difficulties in the interpretation of the Widal test3,4.
In contrast, the Typhoid IgG/IgM Rapid Test is a simple and rapid laboratory test. The test simultaneously detects and differentiates the IgG and the IgM antibodies to S. typhi specific antigen5 thus to aid in the determination of current or previous exposure to the S.typhi.

Reagents and Materials Provided

☀ Individual pouched cassette with desiccant and a disposable plastic pipett.

☀ Operating instruction.

Materials Required But Not Provided

☀ Stop watch.

☀ Disposable gloves. Disinfectant solution.

Specimen Collection and Handling

Consider any materials of human origin as infectious and handle them using standard biosafety procedures.

Plasma

☀ Collect blood specimen into a lavender, blue or green top collection tube by veinpuncture.

☀ Separate the plasma by centrifugation.

☀ Carefully withdraw the plasma into new pre-labeled tube.

Serum

☀ Collect blood specimen into a red top collection tube by veinpuncture.

☀ Allow the blood to clot.

☀ Separate the serum by centrifugation.

☀ Carefully withdraw the serum into a new pre-labeled tube.

Test specimens as soon as possible after collecting. Store specimens at 2°C-8°C if not tested immediately.

Assay Procedure

☀ Bring the specimen and test components to room temperature if refrigerated or frozen. Mix the specimen well prior to assay once thawed.
☀ When ready to test, open the pouch at the notch and remove device. Place the test device on a clean, flat surface.
☀ Fill the pipette dropper with the specimen. Holding the dropper vertically, dispense 1 drop (about 30-45 µL) of specimen into the sample well making sure that there are no air bubbles. Then add 1 drop (about 35-50 µL) of Sample Diluent immediately.
☀ Results can be read in 15 minutes. Positive results can be visible in as short as 1 minute.

Interpretation of Result



Negative: If only the C band presents, the absence of any burgundy color in the both test bands (M and G) indicates that no anti-S. typhi antibody is detected in the specimen. The result is negative or non-reactive.

IgG Positive: In addition to the presence of C band, if only G band is developed, the test indicates for the presence of anti- S. typhi IgG in the specimen. The result is IgG positive or reactive.

IgM Positive: In addition to the presence of C band, if only M band is developed, the test indicates for the presence of anti- S. typhi IgM in the specimen. The result is IgM positive or reactive.

IgM and IgG Positive: In addition to the presence of C band, both M and G bands are developed, the test indicates for the presence of anti-S. typhi IgG and IgM in the specimen. The result is both IgG and IgM positive or reactive.

Invalid: The test results are INVALID, if no control line is visible, regardless of the presence or absence of lines in the IgG or IgM test zone of the strip. Repeat the test using a new cassette.

Storage

Store the kit between 4°C and 30°C. Do not store the kit in direct sunlight. Only remove and open the number of cassettes to be immediately used. The test kit should be used until the expiration date of the kit. Please refer to the package label for the expiration date.

Warning and Precautions

☀ For in vitro diagnostic uses only.

☀ All patient samples should be treated as if capable of transmitting diseases.

☀ Do not use test kit beyond expiration date.

☀ Icteric, lipemic, hemolysed, heat treated and contaminated specimens may cause erroneous results.

Limitation

☀ The Assay Procedure and the Test Result Interpretation must be followed closely when testing the presence of antibodies to S. typhi in serum or plasma from individual subjects. Failure to follow the procedure may give inaccurate results.

☀ The Typhoid IgG/IgM Rapid Test is limited to the qualitative detection of antibodies to S. typhi in human serum or plasma. The intensity of the test band does not have linear correlation with the antibody titer in the specimen.

☀ The Typhoid IgG/IgM Rapid Test also detects para-typhi antibodies.

☀ A negative result for an individual subject indicates absence of detectable anti-S. typhi antibodies. However, a negative test result does not preclude the possibility of exposure to S. typhi.

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.