Customization: | Available |
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Type: | IVD Instrument |
Contents: | Rapid Test+Buffer+Pipette |
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Gastritis and peptic ulcers are among the most common human diseases. Since the discovery of H. pylori (Warren & Marshall, 1983), many reports have suggested that this organism is one of the major causes of ulcer diseases (Anderson & Nielsen, 1983; Hunt & Mohamed, 1995; Lambert et al, 1995). Although the exact role of H. pylori is not yet fully understood, eradication of H. pylori has been associated with the elimination of ulcer diseases. The human serological responses to infection with H. pylori have been demonstrated (Varia & Holton, 1989; Evans et al, 1989). The detection of IgG antibodies specific to H. pylori has been shown to be an accurate method for detecting H. pylori infection in symptomatic patients. H. pylori may colonize some asymptomatic people. A serological test may be used either as an adjunct to endoscopy or as an alternative measure in symptomatic patients.
Product Name | Cat# | Sample Type | Quantiy | Format | Certificate |
H. Pylori Antibody | HP-DW02 | Whole Blood/Serum/Plasma | 40tests/Box | Cassette/Strip | CE |
The H. pylori Antibody Rapid Test (Whole Blood/Serum/Plasma) is a rapid visual It is used to detect Helicobacter pylori antibody in human whole blood, serum or plasma samples.This kit is intended for use as an aid in the diagnosis of H. pylori infection.
· Rapid Test
· Buffer
· Pipette
· Package Insert
1. High accuracy
2. Easy to use
3. Read in short time
4. Result Visible
Bring tests, specimens, buffer and/or controls to room temperature (15- 30°C) before use.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results the assay should be performed within one hour.
2. Testing
For Serum or Plasma
Transfer 2 drops of serum or plasma to the specimen well (S) with the provided disposable pipette, then start the timer.
For Whole Blood
Transfer 1 drop of whole blood to the specimen well (S) of the cassette with the provided disposable pipette, then add 1~2 drop of buffer and start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result area.
As the test begins to work, color will migrate across the result area in the center of the device.
3. Wait for the colored band(s) to appear. The result should be read within 10-15 minutes. Do not interpret the result after 15 minutes
INTERPRETATION OF RESULTS
POSITIVE: The presence of two lines as control line (C) and test line (T) within the result window indicates a positive result.
NEGATIVE: The presence of only control line (C) within the result window indicates a negative result.
INVALID: If the control line (C) is not visible within the result window after performing the test, the result is considered invalid. Some causes of invalid results are because of not following the directions correctly or the test may have deteriorated beyond the expiration date. It is recommended that the specimen be re-tested using a new test.
•The H. pylori Antibody Rapid Test is for professional in vitro diagnostic use, and should only be used for the qualitative detection of H. pylori antibodies.No meaning should be inferred from the color intensity or width of any apparent bands.
• This test should be used for symptomatic individuals with gastrointestinal disorders. Diagnosis of gastritis and/or peptic ulcers should be based on test results in conjunction with other clinical and laboratory findings.
• A positive result suggests only the presence of antibodies specific to H. pylori, and does not distinguish between active and past infections. A positive result is not necessarily indicative of gastrointestinal disease.
• If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time rule out the possibility of H. pylori infection, as antibodies to H. pylori may be present below the minimum detection level of the test.
• Specimens from patients infected with C. jejuni may exhibit a low level of cross-reactivity in this test.
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FAQ
1, Are you a manufacturer?
Yes, we are a manufacturer based in Foshan City, Guangdong province. We have different production lines, more than 5000 square meter facility.
2, Can you put our logo or text on the products or packages?
Yes, we can provide OEM goods.
3, Could you provide free samples for our testing before we place an order?
Sure, we'd like to offer free samples for you, but the freight cost should be paid by the buyer.
4, How to make payment?
T/T, D/P, L/C, Paypal, Western Union and Made in China are both acceptable.
5, Which seaport and airport are the nearest to your factory?
The near seaport is Guangzhou Nansha Seaport & Shenzhen Shekou Seaport. And Guangzhou, Shenzhen, & Hongkong Airports are both convenient.
6, What is your best delivery time?
Depend on your order quantities. 3-20 working days after payment is received.