Helicobacter pylori Antibodies, IgG
| Label Mnemonic: | HYPIGG |
| Epic code: | LAB8917 |
| Downtime form: | A-1a Doctor/Provider Orders - Pathology Core and Specialty Care Nursery |
Commercial Mailout Laboratory
6240-8 RCP
356-8593
6240-8 RCP
356-8593
Collection Medium:
 |
| Red top tube 5 mL (Clot Activator) |
Minimum:
Preferred Minimum: 1 mL serum in a red top tube
Absolute Minimum: 0.5 mL serum in a red top tube
Absolute Minimum: 0.5 mL serum in a red top tube
Rejection Criteria:
Non-serum samples; heat-inativated serum; grossly hemolyzed; icteric or lipemic; samples containing particulate matter or exhibiting obvious microbial contamination.
Delivery Instructions:
Maintain specimen at room temperature.
Testing Schedule:
Testing schedules may vary.
Turn Around
Time:
1-3 days upon recept at reference laboratory. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests.
Reference Range:
Negative: <0.80
Equivocal: 0.80 - 0.89
Positive: >0.89
Equivocal: 0.80 - 0.89
Positive: >0.89
Comments:
Serologic testing for Helicobacter IgG is not recommended as front-line testing due to low specificity and sensitivity. H. pylori Antigen, Stool (LAB4483) or urea breath tests (H. pylori Breath Test (Adult), LAB947; H. pylori Breath Test (Pediatric), LAB8127) are alternatives. This test is a mailout with extended turnaround time. Testing is not recommended for emergency department or inpatient settings.
Reference:
Amieva MR, El‐Omar EM. Host-bacterial interactions in Helicobacter pylori infection. Gastroenterology. 2008 Jan;134(1):306-323. PubMed 18166359
Brown LM. Helicobacter pylori: epidemiology and routes of transmission. Epidemiol Rev. 2000;22(2):283‐297. PubMed 11218379
DiaSorin LIAISON®. H. pylori IgG [package insert]. (REF 318980), US-47667-2017-01.
Kusters JG, van Vliet AH, Kuipers EJ. Pathogensis of Helicobacter pylori infection. Clin Microbiol Rev. 2006 Jul;19(3):449-490. PubMed 16847081
Megraud F. Transmission of Helicobacter pylori: faecal-oral versus oral-oral route. Aliment Pharmacol Ther. 1995;9 Suppl 2:85-91. PubMed 8547533
Reference:
Amieva MR, El‐Omar EM. Host-bacterial interactions in Helicobacter pylori infection. Gastroenterology. 2008 Jan;134(1):306-323. PubMed 18166359
Brown LM. Helicobacter pylori: epidemiology and routes of transmission. Epidemiol Rev. 2000;22(2):283‐297. PubMed 11218379
DiaSorin LIAISON®. H. pylori IgG [package insert]. (REF 318980), US-47667-2017-01.
Kusters JG, van Vliet AH, Kuipers EJ. Pathogensis of Helicobacter pylori infection. Clin Microbiol Rev. 2006 Jul;19(3):449-490. PubMed 16847081
Megraud F. Transmission of Helicobacter pylori: faecal-oral versus oral-oral route. Aliment Pharmacol Ther. 1995;9 Suppl 2:85-91. PubMed 8547533
Test
Limitations:
Assay results should be utilized in conjunction with other clinical and laboratory data to assist the clinician in making individual patient management decisions. Heterophilic antibodies in human serum can react with reagent immunoglobulins or other reagent material, interfering with in vitro immunoassays.
This assay has not been evaluated in a pediatric population.
This assay should be used only to evaluate patients with clinical signs and symptoms suggestive of gastrointestinal disease and is not intended for use with asymptomatic patients.
A positive test result does not allow one to distinguish between active infection and colonization by H. pylori. A positive test only indicates the presence of IgG antibody to H. pylori and does not necessarily indicate that gastrointestinal disease is present.
A negative test indicates that IgG antibody to H. pylori is not present or is at a level that cannot be detected by the assay.
This assay has not been evaluated in a pediatric population.
This assay should be used only to evaluate patients with clinical signs and symptoms suggestive of gastrointestinal disease and is not intended for use with asymptomatic patients.
A positive test result does not allow one to distinguish between active infection and colonization by H. pylori. A positive test only indicates the presence of IgG antibody to H. pylori and does not necessarily indicate that gastrointestinal disease is present.
A negative test indicates that IgG antibody to H. pylori is not present or is at a level that cannot be detected by the assay.
Methodology:
Chemiluminescence immunoassay (CLIA)
CPT Code:
86677
See also:
H. pylori Antigen, Stool
H. pylori Breath Test, Breath
H. pylori Breath Test, Pediatric, Breath
H. pylori Antigen, Stool
H. pylori Breath Test, Breath
H. pylori Breath Test, Pediatric, Breath