PACKAGE SPECIFICATION
20 tests/kit, 40 tests/kit.

INTENDED APPLICATION

Immunochromatographic rapid assay for the Detection of Rotavirus Antigens in
Human Stool Specimens The test results are intended to aid in the diagnosis of rotavirus infection and to monitor the effectiveness of therapeutic treatment.

TEST PRINCIPLE
The test is a sandwich solid phase immunochromatographic assay. To perform the test, an aliquot of diluted stool sample is added to the sample well of the test card. The sample flows through a label pad containing rotavirus antibody coupled to red-colored colloidal gold. If the sample contains rotavirus antigens, the antigen will bind to the antibody coated on the colloidal gold particles to form antigen-antibody-gold complexes. These complexes move on the nitrocellulose membrane by capillary action toward the test line area on which rotavirus specific antibodies are immobilized. As the complexes reach the test line, they will bind to the antibody on the membrane in the form of a line. A second red control line will always appear in the result window to indicate that the test has been correctly performed and the test device functions properly. If rotavirus antigen is not present or lower than the detection limit of the test, only the control line will be visible. If the control line has not developed, the test is invalid. 

MAIN COMPONENTS 
20 tests/kit 40 tests/kit
Test card 20pcs 40pcs
sample collection bottle (1ml buffer contained) 20  pcs 40  pcs
Instruction 1pcs 1pcs

SUCCESSIVE OPERATING PROCEDURES
1) Before using the kit,you must read this introduction,and make sure that the kit and samples were returned to room temperature.
2) Open the sample collection bottle which has contained stool collection buffer, take one mung bean sized (about φ 5 mm) stool sample using  a wooden stick, then put it into  the sample collection bottle , cover back and screw up. Squeeze and shake the bottle thoroughly and finally keep resting for 2 minutes.
3) Take out one test card and make sure it should be used within 30 minutes. The card should be put on the clean, dry, flat test stand. Break off the top part of the bottle. Drop 2-3 drops sample  extract into the sample well (S).
4) Read the result in 10 minutes. A strong positive sample may show result earlier. The result is not valid after 20 minutes.

PERFORMANCE INDICATORS
Positive compliance rate: ≥99%;
Negative compliance rate: ≥99%;
Intra batch discrepancy: ≤1%;
Inter batch discrepancy: ≤1 %.

Zhuhai Encode Medical Engineering Co.,Ltd (herinafter referred to as Encode) was established in 1994, as one of the earliest
and largest manufacturers of in-vitro diagnostic field in China. Encode specializes in R&D, production and distribution of in-vitro diagnostic products. As a hi-tech and innovative enterprise, we have researched and developed series of microbiological diagnostic productds and immunology diagnostic rapid tests, which are used for diagnosis of infection disease, cardiac markers, tumor markers, fertility test, durgs of abuse and sexual transmitted disease.

Encode occupies a land of 15,000 m2 in Zhuhai. There are 2,000 GMP standard clean workshops of microbiology diagnostic products, colloidal gold diagnostic products and molecular with automatic manufacturing lines and passed the quality management system evaluation by SFDA and GDFDA.

Encode has established extensive cooperation with research centers in universtities, such as Lanzhou University, South China University of Technology, Jinan University and Shanghai Plumonary Hospital, etc. Whith strong R&D and technological innovation capability. Encode ranks leading level in terms of IVD industries field in China. We have also obtained ISO 13485:2003, ISO 9001:2001, CE and have been granted the title of national hi-tech enterprise.

Today, we provide medical products and health care solution to clients not only in China, but also worldwide, such as Europe, Africa, Middle East, South East, Asia etc.

With the experience and dedication of the scientific staffs, Zhuhai Encode Medical Engineering Co.,Ltd will continue our endeavor to provide professional in-vitro diagnostic products and health care solutions to the worldwide and make our contributions to the career of human health.