INTENDED USE

 

The test kit utilize purified Chlamydia Trachomatis Antibody antigen, based on GIFA principle and use indirect method to detect Urea Plasma Urealyticum antibody in human serum.

 

TEST PROCEDURE

 

1. Remove the test kit and put it at room temperature (for about 20-30mins) before testing.

2. Add 1 drop of Wash Buffer into the hole and allow the liquid soak the membrane completely.

3. Add 150ｕl of the serum specimen into the hole and allow it to sufficient absorption.

4. Add 3 drops of Colloidal Conjugate into the hole and allow it to sufficient absorption.

5. Add 3 drops of Wash Buffer into the hole and allow it to sufficient absorption. Read the results within 3 minutes.

 

INTERPRETATION OF RESULTS

 

Negative: Only one colored point appear on the control region. No apparent point on the test region.

Positive: In addition to a colored control point, a distinct pink colored point will also appear in the test region.

Invalid: A total absence of colored point in both (T) and (C) regions or no colored point appears on the control (C) region is an indication of procedure error and/or that the test reagent has deteriorated.

 

 

STORAGE

 

The kit can be stored at room temperature (2-30°C). The test kit is stable through the expiration date (18 months) marked on the foil pouch. DO NOT FREEZE. Do not store the test kit in direct sunlight.

 

PRECAUTION

 

1. Must need fresh serum not plasma. Some specimens ( hyperlipemia, hemolysis etc.) won’t affect results.

2. No time intervals in every procedure. Add the liquid rapidly one time and allow it inleakage in same procedure.

3. The test result is invalid after the stated time.

4. The strong or weak point doesn’t mean superior or inferior quality. As long as the color is clear Then the reagent is valid.

5. The components from different lots should not be mixed.

 

LIMITATION

 

1. Like all qualitative test reagent, the test kit is only used as screening examination.

2. Negative results may occur when levels of Ct antibody are below or doesn’t exist.

 

STORAGE AND STABILITY

 

1. Store the kit at 2-8℃. Period of validity is 6 months.

2. The kit can be shipped in short period at room temperature. Avoid freezing, thawing and high temperature.

Anna Lee

Int'l Market Executive                                         
Newscen
Tel:  +86(755)89589611
Cell Phone:+8613417551798(WhatsApp)
EMAIL: info@spanbio.com

NewScen is professional IVD products manufactuer and POCT service provider, founded in 2003. Our factory is located in Tianjin, one of biggest prot city in Northern China, which benefit us from convenient logistics, and enable us fulfill better order delivery to our customers. WE have more than 16 years of industry experience and exprot experience. Products are sold throughout the country and in North America, South America, Southeast Asia, Europe, the Middle East, Africa and other international markets. And our HIV and HCV products have both got CE approval and passed WHO laboratory evaluation.

We dedicated provide our customers an ectensive range of RDTs in satisfying performance with favorable price. Both finished products, semi-finished products, OEM products, Uncut sheets are availabel for our cooperation.