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

PACK TYPE
 Gray cardboard box.

INTENDED APPLICATION
Adeno/Rota Combo Test is an in vitro qualitative immunochromatographic assay for the rapid detection of adenovirus rotavirus antigens in human stool specimen. The test results are intended to aid in the diagnosis of rotavirus infection and to monitor the effectiveness of therapeutic treatment.
For the clinical characterization of Rotavirus/Adenovirus antigen in infant stool.

TEST PRINCIPLE
Adeno/Rota Combo 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 pad containing antibodies against adenovirus and rotavirus coupled to red-colored colloidal gold. If the sample contains adenovirus or 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 adenovirus and rotavirus specific antibodies are immobilized separately. As the complexes reach the test line, they will bind to the antibody corresponding to the virus on the membrane to form of a line. A 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 virus is not present or lower than the detection limit of the test, only the control line will be visible. If the control line dose not developed, the test is invalid.
The function parts of the test kit are diluting liquid and test cards which contain immunological reagent on the chromatographic membrane. The stationary reagent line that has been applied onto the membrane in the test area (T) is otherwise invisible, but if the sample passing through membrane contains Rotavirus group A antigen to the specific Rotavirus group A antibody,the line turns distinctly red in the test area(R),if the sample passing through membrane contains Adenovirus antigen to the specific Adenovirus antibody,the line turns distinctly red in the test area(A). The control line that has been put on the membrane in the control area (C) invisible before the test turns red during the assay process, thus indicates proper performance of the test device. Regardless of the existence of Rotavirus/Adenovirus antigen in the sample, the control line will appear.

MAIN COMPONENTS
20 tests/kit 40 tests/kit
Test card 20pcs 40pcs
Diluting liquid Sample Collection Bottle (1ml buffer contained) 20 bottles pcs 40 bottles pcs
Instruction 1pcs 1pcs

STORAGE AND PERIOD OF VALIDITY
Stored in a dry place at 4-30°C and valid for; 18 months.

SAMPLE REQUIREMENTS
Stool can be used as the sample for this test kit. Samples when not used at once shall may be stored refrigerated(2°C-8°C) for two days,also can be frozen(-20°C)for long-term storage,but avoid repeated freezing and thawing. Fresh sample is recommended.

SUCCESSIVE OPERATING PROCEDURES
1)Read the instruction Before before using the kit,you must read this introduction,and make sure that the kit and samples were returned to room temperature.
2) Open Uncover the bottle which has diluting liquid the sample collection buffer, take one of the mung bean sized (about φ 5 mm) of the stool sample using with the a wooden stick on the cap, then put it into extracting liquid the bottle and  cover back and screw it upturn off the cap. Squeeze and shake the bottle hard thoroughly and finally keep resting for 2 minutes.
3) Take out one test card from the sealed foil pouch 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 cap bottle cover. You just need to drop Drop 2-3 drops of sample diluting liquid extract into the sample hole well (S).
4)Read the result in 10 minutes. Strong positive result will show earlier. The result is not acceptable valid after 20 minutes.

RESULTS EXPLANATION
Positive: A distinct pink colored band appears on test line regions, in addition to a pink line on the control line area.
Negative: No line appears in the test line region. A distinct pink line shows on the control line area.
Invalid: The control line next to the test line does not become visible within 10 minutes after the addition of the sample.

1)A positive result(the antigen activity of the sample is above the cut-off level of the test)is indicated as a distinctly visible red line in the test area(R/A)and a red line in the control area(C).
2)A negative result(the antigen activity of the sample is below the cut-off level of the test)is indicated by the absence of a distinctly visible red line in the test area(R/A)and the presence of a red line in the control area(C).
3)A invalid result is indicated by the absence of a distinctly visible red line in the control area(C), this test should be repeat.
4)If there are two red lines in the test area(R/A)and control area(C),even though the red line in the test area(R/A)is very light,the positive result should be ruled .

TEST LIMITATIONS
1) Ideal test results should fully comply with the above testing procedures. Operation error may lead to incorrect results.
2) The test kit is for in vitro diagnostic use and the detection of antigen in stool samples only,the result is just a qualitative analysis , not a quantitative detection.
3) The test result should be used only to evaluate with patient with signs and symptoms of the
disease. A definitive clinical diagnosis should only be made by the physician after all clinical and laboratory finding have been evaluated.
A positive result or a negative result just show that the antigen activity of the sample is above or below the cut-off level of the test,the result can not be used as the sole criterion of Rotavirus/Adenovirus infection. If necessary,other methods or equipment are needed,Professionals should according to the further test results and clinical symptoms to make judgments.

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