One Step Rotavirus & Adenovirus Combo Rapid Diagnostic Cassette, feces specimen,gold colloidal method, easily and quick

Product Name: One Step Rotavirus & Adenovirus Combo Rapid Diagnostic test

Intended Use:

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.

Test Principle:

The Rota-Adenovirus cassette is a one step coloured chromatographic immunoassay for the qualitative detection of Rotavirus and/or Adenovirus in stool samples. The membrane is pre-coated with monoclonal antibodies, on the test band region, against viral antigens. During testing, the sample is allowed to react with the coloured conjugate (anti-rotavirus monoclonal antibodies-red microspheres and anti-adenovirus monoclonal antibodies-blue microspheres) which was pre-dried on the test strip. The mixture then moves upward on the membrane by capillary action. As the sample flows through the test membrane, the coloured particles migrate. In the case of a positive result the specific antibodies present on the membrane will capture the coloured conjugate. Different coloured lines will be visible, depending upon the virus content of the sample. These lines are used to interpret the result.

SPECIMEN COLLECTION AND PREPARATION

Stool samples must be taken as soon as the symptoms appear. Viral particles decrease in number after one week. Stool specimens should be collected in containers that do not contain media, preservatives, animal serum or detergents as any of these additives may interfere with the Rotavirus Antigen Test. Specimens may be stored at 2-8oC for 2 days without interfering with the assay performance. For long-term storage of specimens, 20oC or colder is recommended. Repeated freezing and thawing of specimens is not recommended and may cause erroneous results. Do not store specimens in self-defrosting freezers.

TEST PROCEDURE

Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.

For liquid specimens: Hold the pipette vertically, aspirate fecal specimens, and then transfer 2 drops (approximately 50 µL) into the specimen collection tube containing the extraction buffer.

Place the applicator back into the tube and screw the cap tightly. Be careful not to break the tip of the dilution tube.

Shake the specimen collection tube vigorously to mix the specimen and the extraction buffer. Specimens prepared in the specimen collection tube may be stored for 6 months at -20°C if not tested within 1 hour after preparation.

Avoid trapping air bubbles in the specimen well (S), and do not drop any solution in observation window.

As the test begins to work, you will see color move across the membrane.

Wait for the colored band to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.

Note: If the specimen does not migrate (presence of particles), centrifuge the extracted specimens contained in the extraction buffer vial. Collect 80 µL of supernatant, dispense into the specimen well (S) of a new test device and start afresh following the instructions mentioned above.

INTERPRETATION OF RESULTS

POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).

*NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration of present in the specimen. Therefore, any shade of color in the test line region (T) should be considered positive.

NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line region (T).

INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

PERFORMANCE CHARACTERS:

Table: Adenovirus Rapid Test vs. Latex Agglutination

Table: Rotavirus Rapid Test vs. Latex Agglutination

NOTE: Insufficient specimen volume or incorrect procedural techniques are the reasons

for the control line failure. Review the procedure and repeat the test with a new device. If problem persists, please contact your local distributor.

Established in 2009, Orient New Life Medical Co., Ltd., is specialized in high-tech biological diagnostic test development, research and production, as well as high-tech medical device development, research and production. New Life has built up two production base, which produce biological diagnostic test and endoscopic medical device respectively. Our products ranged in the following specialties: drug of abuse tests, fertility tests, infectious diseases tests, sexual transmitted diseases tests, tumor markers tests, cardiac markers tests, veterinary tests, and surgical stapler series.

NEW LIFE have 3 wholly-owned and joint stock subsidiary companies, including Orient New Life Medical  Co., Ltd., Orient Gene Biotech Co., Ltd., Qianjing Medical Equipment Co., Ltd.

Company's core technical team with more than 35 employees，3 doctors and 25 masters. They have many years of famous universities in the United States and pharmaceutical companies engaged in the project research and development, production and marketing, business management experience.Company owns hundreds of grade purification workshop and all level of quality checkout room, equipped with various production and testing equipment.