Unit: 1 Box (10 Tests)
Regulatory Status: CLIA Waived (whole blood) / Moderately Complex (serum/plasma) / Professional Use Only
Contents: (10) Test Cassette, (10) Disposable Droppers, (10) Capillary Tubes, (1) Positive Control, (1) Negative Control, (2) Package Insert, & (1) Procedure Card
Determinations: Qualitative H. pylori
Storage Requirements: 59° – 86° F
Sample Volume: 50 uL (approximately)
Processing Time: 5 minutes
The QuickVue H. pylori gII is a simple, on-site assay that offers a qualitative result to determine the presence or absence of H. pylori in 5 minutes or less. H.pylori is a species of spiral, Gram-negative bacteria with multiple sheathed flagella that can infect and weaken the gastric mucosa, allowing digestive juices to irritate the sensitive stomach lining. H. Pylori is responsible for more than 80% of all gastric ulcers and is classified by the W.H.O. as a group I carcinogen.
QuickVue H. pylori gll Test Includes:
10 Capillary Tubes
2 Package Inserts
1 Procedure Card
1 Set Positive & Negative Controls
- Inexpensive – No costly equipment needed
- CLIA Waived – Whole Blood Specimen Only / CLIA Moderately Complex – Serum and Plasma Samples
- Easy – One-Step Procedure
- Small Sample Size – Capillary Tube or Dropper – 50 uL / Hanging Drops – 2
- Accurate – Includes both Internal & External Controls to insure compliance and confidence in results
- Long Shelf Life – 14 months from date of manufacture
- No special storage or shipping required – Stable at Room Temperature (59-86 degrees F)
About H. pylori
Helicobacter pylori (H. pylori), formerly known as Campylobacter pylori, is a Gram-negative, urease-positive, microaerophilic bacterium. This gastric pathogen is believed to be present in the digestive systems of half the world’s population. Scientists believe H. pylori may be spread through contaminated food and water. In the U.S., studies indicate that 20% of people under 40 years and 50% of people over 60 years of age are infected with H. pylori. Infected individuals typically carry the infection for life unless they are treated with antibiotics to eradicate the bacterium.
H. pylori is often asymptomatic; however for some, the symptoms range from minor discomforts such as belching, bloating, nausea, and vomiting to more serious symptoms such as burning abdominal pain; dark, tarry stools; decreased appetite; weight loss; fatigue; and low red blood count due to bleeding. H. pylori is a common cause of stomach inflammation (gastritis) and peptic ulcers. The bacteria’s spiral shape allows it to penetrate the stomach’s protective mucous membrane where it releases cytotoxins, weakening the stomach lining and making it more susceptible to damage from gastric acid. Over time, presence of the bacteria increases the risk of stomach cancer including a rare type of lympocytic tumor known as MALT (mucosa-associated lymphoid tissue) lymphoma.
Testing for H. pylori is strongly recommended if peptic ulcer disease or gastritis is present. Simple, accurate tests for the detection H. pylori, such as the QuickVue gll, are now readily available. Antacids, H2-blockers and proton pump inhibitors can be used to effectively treat symptoms caused by H. pylori; however, they can not eradicate the bacterium from the digestive system. Diagnosis and antibiotic therapy are the only courses of eradication to prevent more serious conditions that H. pylori can cause.