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Quick Details

  • Brand Name: EGENS
  • Place of Origin: Jiangsu, China (Mainland)
  • Model Number: Cassette

Packaging & Delivery

Packaging Details 25PCS/BOX 80BOX/CTN
Delivery Time 10-15days

Specifications

Rotavirus (ROV) Antigen Detection Kit
Brand Name: egens

Rotavirus (ROV) Antigen Detection Kit

 

 

 

[Product name]

 

Rotavirus Antigen 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. The Rotavirus Test Device is a rapid chromatographic immunoassay for the qualitative detection of rotavirus in human fecal specimens to aid in the diagnosis of rotavirus infection.

 

[Inspection principles]

 

Rotavirus antigen Rapid Test is a immunoassay utilizing highly specific reactions between double antibodies sandwich for the detection of rotavirus 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 rotavirus 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 Rotavirus antigen in the sample, the control line will appear.

 

 

 

[Main components]

 

Specifications

Name of component

Quantity

Main biochemical compositions

Card type

Colloidal gold method test paper card of Rotavirus antigen

One card

The test contains a membrane strip coated with rotavirus  antibody conjugates on the test line, a goat polyclonal antibody against gold-protein conjugate at the control line, and a dye pad which contains colloidal gold particles coated with rotavirus antibody .

Instructions

One piece

Printing paper

Sample extraction liquid

One bottle

2ml Normal saline

Strip type

Colloidal gold method test paper strip of Rotavirus antigen

One strip

The test contains a membrane strip coated with rotavirus antibody conjugates on the test line, a goat polyclonal antibody against gold-protein conjugate at the control line, and a dye pad which contains colloidal gold particles coated with Rotavirus antibody .

Instructions

One piece

Printing Paper

Sample extraction liquid

One bottle

2ml Normal saline

 

 

 

[Storage conditions and period of validity]

 

Avoid light, dry preservation at 2-30,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 detected immediately, the samples shall be stored refrigerated(2-8℃) for 72 hours,also can be frozen(-20℃)for long-term storage.

 

[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.       

 

For Strip:

 

1.Take out one test strip and make sure it should be used within an hour. The strip 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 end of the strip.

 

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

 

For Card:

 

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 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 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.

 

 

 

[Interpretation of the results]

 

1.The purple red stripe at the quality control line is the standard of internal control of the kit, and which can be used to determine whether there is enough samples, whether the chromatography process is normal, whether correct operation steps are used, as well as whether the test results are right.

 

2.When detecting different samples, the purple red stripes at the detection line can take on different color depths, and which is caused by different antigen concentrations of Rotavirus antigen . But, in the specified time, regardless of color depth of the colored tape, even if there is only very weak colored tape, the sample shall be determined as the positive.

 

[Test method and limitations]

 

1.The kit is only used for detecting Rotavirus antigen in the samples of human stool.

 

2.Accuracy of the detection depends on the sampling progress, if the sampling and storage are improper, or the sample is not fresh, or the sample is conducted freeze and thaw, all above can affect the detection results.

 

3.If the sample is stored in individual medicines, such as OTC with high concentration and prescription medicines, the detection results may be interfered. If the results are suspicious, please test again.

 

4.The test card can only be used for qualitative detection of Rotavirus antigen in the human stool samples. If you want to detect specific contents of some indicator, please use relevant special instruments.

 

5.The positive results only show the existence of Rotavirus antigen in the samples, and which can not be treated the only standard to judge that the organism has infected Rotavirus antigen. And the detection results must be diagnosed by the doctor combining with other clinical symptoms as well as the detection indicators from other laboratories.

 

6.If the detection results negative, but there are clinical symptoms, we suggest using other clinical methods for testing. The negative results can not completely eliminate the possibility of infecting rotavirus antigen.

 

[Performance indexes of the products]

 

1) Detection Limit

 

Minimal detection limit for Rotavirus antibody is 1/1000.

 

2) Interfering substances

 

When the sample concentration is below the level of the material shown in the following list, and does not affect the test results.

 

Name

Concentration

Ascorbic acid

20mg/dL

Oxalic acid

1000mg/dL

Hemoglobin

1000mg/dL

Human serum albumin

2000mg/dL

Bilirubin

60mg/dL

Triglycerides

500mg/dL

 

3) Cross Reaction

 

When the sample concentration is below the level of the 107 bacteria/ml , and does not affect the test results.

 

Name

Name

Staphylococcus aureus

Neisseria gonorrhoeae

Pseudomonas aeruginosa

B streptococcus

Streptococcus C

Proteus vulgaris

Mucositis Brenham cocci

Feces Enterococcus

White rosary

Proteus variation

Neisseria meningitidis

Acinetobacter

Chlamydia trachomatis

Salmonella

Calcium acetate Acinetobacter

Vaginalis

E. coli

 

 

The results show that those bacterias in stool specimens above are all negative.

 

 

 

[Descriptions and notes]

 

1.The test strip /test card can only be used for in vitro diagnosis test. And which is suitable for testing the samples of human stool samples, and you may not get accurate results about other body fluid and samples.

 

2.In the test environment, there shall be not wind, no high temperature and high humidity; the test environment shall be not too dry.

 

3.When the package is opened, the test stripe/card shall be tested as soon as possible, to avoid being stayed in the air for a long time, resulting in damp and invalid. If the inner package is damaged, the product shall be not used.

 

4.The kit can be stored at room temperature, avoid damp. The kit stored at low temperature can not be used until it is balanced to room temperature.

 

5.Operate according to inspection rules of the infectious disease laboratories.

 

6.If the detection results take on negative, while there are clinical symptoms, we shall conduct further clinical detection. The negative results can not eliminate the possibility of Rotavirus antigen.

 

7.We can only get initial screening products using this method; any positive results shall be further confirmed adopting other methods.

 

8.When testing a large number of samples, pleas make tags, avoid confusion.

 

9.The test card can only be used for disposable in vitro diagnosis; and the same test card can not be used repeatedly. After being frozen or invalid, the test cart must not be used.

 

 

 

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