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item
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value
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Place of Origin
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China
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Brand Name
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testsealabs
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Model Number
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H.pylori Antibody Rapid Test ag test |
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Power Source
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Manual
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Warranty
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2 years
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After-sale Service
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Online technical support
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Power Supply Mode
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Plug-in
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Material
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Plastic
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Shelf Life
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2 years
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Quality Certification
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ISO9001/ ISO13485 CE |
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Instrument classification
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Class II
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Safety standard
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GB15979-2002
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Intended Use
The One Step H.pylori Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies to H.pylori (HP) in Whole Blood /Serum / Plasma to aid in the diagnosis of H.pylori
Detection for: H.pylori antibodies in whole blood, serum, or plasma.
Specimen volume: Serum or plasma Specimen: 100 μL
Venipuncture or Fingerstick whole blood specimen: 50 μL
Reading time: 10 minutes;
Relative Sensitivity: 93.8%(88.2%-97.3%)
Relatively Specificity: 89.7%(84.4%-93.7%)
Accuracy: 91.4%(87.8%-94.3%)*
Summary
H.Pylori is associated with a variety of gastrointestinal diseases included non-ulcer dyspepsia, duodenal and gastric ulcer and active, chronic gastritis. The prevalence of H. pylori infection could exceed 90% in patients with signs and symptoms of gastrointestinal diseases. Recent studies indicate an association of H. Pylori infection with stomach cancer. H. pylori colonizing in the gastrointestinal system elicits specific antibody responses which aids in the diagnosis of H. Pylori infection and in monitoring the prognosis of the treatment of H. pylori related diseases. Antibiotics in combination with bismuth compounds have been shown to be effective in treating active H. pylori infection. Successful eradication of H. pylori is associated with clinical improvement in patients with gastrointestinal diseases providing a further evidence.
Test Procedure
1.Bring the pouch to room temperature before opening it. Remove the test strip or the cassette from the sealed pouch and use it within one hour
For Test Strip:
1.) Peel off the tape from the test card. and stick the test strip in the middle of test card with arrows pointing down on the test card as illustrated
2.) Place the strip on a clean and level surface.
For Serum or Plasma specimen:
Hold the dropper vertically and transfer 4 drops of serum or plasma (approximately 100 μL) to the specimen well of test strip and start the timer. See illustration below.
For Venipuncture Whole Blood specimen:
Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50 μL) to the specimen well. then add 1 drop of buffer (approximatel40 μL),and start the timer. See illustration below.
For Fingerstick Whole Blood specimen:
To use a capillary tube: Fill the capillary tube and transfer approximately 50 μL of fingerstick whole blood specimen to the specimen area of test strip, then add 1 drop of buffer (approximately 40 μL) and start the timer. See illustration below.
For Test Cassette:
Place the cassette on a clean and level surface.
For Serum or Plasma specimen:
Hold the dropper vertically and transfer 4 drops of serum or plasma (approximately 100 μL) to the specimen well of rapid test Cassette and start the timer See illustration below.
For Venipuncture Whole Blood specimen:
Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50 μL) to the specimen well, then add 1 drop of buffer (approximately 40 μL) and start the timer See illustration below
For Fingerstick Whole Blood specimen:
To use a capillary tube: Fill the capillary tube and transfer approximately 50μL of fingerstick whole blood specimen to the specimen area of rapid fest cassette, then add 1 drop of buffer (approximately 40 μL) and start the timer. See illustration below
2.Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes
LIMITATIONS
1.H.pylori Antibody Rapid Test Cassette/Strip (Whole Blood/Serum/Plasma) is for in vitro diagnostic use only. The test should be used for the detection of H.pylori antibodies in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in H.pylori antibody concentration can be determined by this qualitative test.
2.ACCU-TELLH.pylori Antibody Rapid Test Cassette/Strip (Whole Blood/Serum/Plasma) will only indicate the presence of H.pylori antibodies in the specimen and should not be used as the sole criteria for the diagnosis of H.pylori infection.
3.As with all diagnostic tests. all results must be interpreted together with other clinical information available to the physician
4. 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 preclude the possibility of H.pylori infection
1. who are we?
We are based in Zhejiang, China, start from 2018,sell to South Asia(40.00%),South America(10.00%),Africa(10.00%),Mid East(10.00%),Eastern Asia(10.00%),Western Europe(10.00%),Southern Europe(10.00%). There are total about 201-300 people in our office.
2. how can we guarantee quality?
Always a pre-production sample before mass production;
Always final Inspection before shipment;
3.what can you buy from us?
infectiouse disease test,drug of abuse test,tumor marker test,tumor markers test,cardiac marker test
4. why should you buy from us not from other suppliers?
high-tech enterprise , specialized in the research, development productio and sales of raw materials, more than 2000 square meters , including 400 square meters of GMP100 000-level purification workshop , follow with ISO
5. what services can we provide?
Accepted Delivery Terms: FOB,CFR,CIF,EXW,FCA,DDP,DDU;
Accepted Payment Currency:USD,EUR,CNY;
Accepted Payment Type: T/T,Credit Card,PayPal,Western Union,Cash;
Language Spoken:English,Chinese,Japanese
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