One Step Test Kit Rapid Test Rotavirus Test Kit

• Type: IVD Reagent
• Certification: Ce, FDA, ISO13485
• Transport Package: Foil Bags
• Trademark: OEM
• Origin: China
• HS Code: 38220090

Product Description

Rotavirus And Adenovirus Antigen Combo Detection Kit (Colloidal Gold)

Packing specification
Sealed package with foil bags, every bag contains the dosage taken once for each person.

Intended application
Acute diarrhea disease in young children is a major cause of morbidity worldwide and is a leading cause of mortality in developing countries. Rotavirus is the most common agent responsible for acute gastroenteritis, mainly in young children. Rotavirus is transmitted by oral-fecal route with an incubation period of 1-3 days. In temperate climates, rotavirus infections occur mainly in the winter months. Adenovirus can infect respiratory tract, gastrointestinal tract, urinary tract, eye and liver. Adenovirus serotypes are known about 1/3 is typically associated with human disease, but a different serotypes can cause the same disease.
The rotavirus and adenovirus combo test device is a rapid chromatographic immunoassay that uses a double antibodies sandwich method for the qualitative detection of rotavirus and adenovirus in human fecal specimens to aid in the diagnosis of rotavirus or adenovirus infection.

Inspection principles

Rotavirus Group A antigen and Adenovirus antigen Rapid Test is a immunoassay utilizing highly specific reactions between double antibody sandwich for the detection of Rotavirus Group A antigen and Adenovirus antigen in human stool samples.

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 passes through membrane contains antigen to the specific Rotavirus antibody, the line turns distinctly red in the test area. 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 antigen in the sample, the control line will appear.

Specifications	Name of component	Quantity	Main biochemical compositions
Card type	Colloidal gold method test paper card of Rotavirus and Adenovirus antigen	One card	Rotavirus:The test contains a membrane strip coated with rotavirus monoclonal antibody conjugates on the test line, a goat anti-mouse polyclonal conjugate at the control line, and a dye pad which contains colloidal gold particles coated with rotavirus monoclonal antibody and mouse monoclonal antibody. Adenovirus:The test contains a membrane strip coated with adenovirus monoclonal antibody conjugates on the test line, a goat anti-mouse polyclonal antibody against conjugate at the control line, and a dye pad which contains colloidal gold particles coated with adenovirus monoclonal antibody and mouse monoclonal antibody.
	Instructions	One piece	Printing Paper
	Sample extraction liquid	One bottle	2ml Normal saline

Test method:

Firstly, read the operation instructions completely.

Before testing, recover all reagents to the room temperature and the test shall be conducted at room temperature..

1. Take out one test card and make sure it should be used within an hour. The card should be put on the clean, dry, flat test
stand. Break off the top of the cap. You just need to drop 2-3 drops sample extracting liquid in the sample hole (S).

2. Read the result in 15 minutes. The result is not acceptable after 20 minutes.


Interpretation of the results

Negative: There is only one purple red stripe at the quality control line on the test strip/test card. And the negative results
show that: No Rotavirus or Adenovirus antigen can be detected.

Positive: Two purple red stripes appear at the places of detection line and quality control line on the test strip/test card.
Positive results show that: there is rotavirus or adenovirus antigen in the sample.

Invalid: There is no purple red stripe at the control line, and which shows that the operation process is not right or the kit has been invalid. In this case, please read the instructions carefully again, using a new test card to detect again. If there are problems, the use of this batch of products shall be stopped immediately, to contact local supplier.

Storage conditions and period of validity

Avoid light, dry preservation at 2-30ºC,no cryopreserving. The period of validity is 24 months since the date of production

Sample collection and handling

1.Sample requirements:
a.) We must collect the fresh stool samples, not mixed with the urine, disinfectant and sewage. No abnormal appearance of the stool must be collect in the surface, deep and fecal end. If feces containing mucus and blood components and other diseases can be drawn as one of the priorities selected point, and then select another look no abnormal feces
b.) The specimen must be collected in a clean, dry, waterproof and contain no detergents, preservatives and media containers.

2.Sample collection:
a.) Open the collection tube, remove the sample rod.
b.) Collect the sample from the different place of the stool (about 50mg),and put the sample rod to the collection tube witch has the normal saline. Such as liquid manure, please use the sample pipette and dropped two drops (approximately 100ul) to the collection tube;
c.) Tighten the lid, mix well and set aside.

3.Recommendations prepared sample detected in time. If you can not immediately detected, the samples shall be stored refrigerated(2-8ºC)for 72 hours,also can be frozen(-20ºC)for long-term storage.


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