GastroPanel® Biomarker Assay: The Most Comprehensive Test for Helicobacter pylori Infection and Its Clinical Sequelae. A Critical Review

Abstract

Background/Aim: Several clinical conditions seriously hamper the diagnostic accuracy of the commonly used tests for Helicobacter pylori (Hp), 13 C-urea breath test (UBT) and stool antigen test (SAT). The present communication is a critical review of the potential limitations of UBT and SAT, and describes the approach on how these can be avoided. Drawbacks of the Hp tests: False-negative results are most often due to low bacterial load in the stomach due to: i) use of proton pump inhibitor medication; ii) use of antibiotics; iii) presence of atrophic gastritis and hypoacid stomach; iv); bleeding peptic ulcer; v) gastric cancer (GC) and vi) mucosal-associated lymphatic tissue lymphoma. The UBT also gives false-positive results when urease-producing bacterial species, other than Hp colonize an acid-free stomach. Importantly, neither UBT nor SAT are capable of 1091 This article is freely accessible online.

Helicobacter pylori (Hp) IgG ELISA of the New-Generation GastroPanel® Is Highly Accurate in Diagnosis of Hp-Infection in Gastroscopy Referral Patients

“…Apart from the recommended 10-h fasting before sampling, the study subjects were instructed to discontinue their eventual PPI-medication, preferably one week before GastroPanel ® sampling. If not possible due to intractable dyspeptic symptoms, a notice of PPI use had to be included in the GastroPanel ® referral form, including the information whether PPI was interrupted or not, and for how many days (28)(29)(30).…”

“…Sample collection and processing. For consistent interpretation of the test results by the GastroSoft ® application (Biohit Oyj), it is mandatory to complete the GastroPanel ® referral form, as detailed before (28)(29)(30). A minimum of 2 ml EDTA plasma from a fasting blood sample was taken into an EDTA tube.…”

Review: Diagnosis of Helicobacter pylori infection

“…48 Skrebinska et al assessed the accuracy of two plasma antibody test-systems (latex agglutination and ELISA) and a SAT in comparison with histology as the gold standard in a general population sample in Latvia. 50 49 A critical and extensive review of the limitations of the UBT and serology and the advantages of the combined testing of H. pylori antibodies and biomarkers such as pepsinogen I + II and gastrin-17 (GastroPanel ® ) was published by Finnish researchers.…”

Atrophic gastritis in Chernobyl nuclear power plant accident recovery workers in remote period

“…Наличие H. pylori в СОЖ определяли с помощью иммуноглобулинов класса G к данной бактерии. Выбор данного метода был обусловлен тем, что в условиях анацидности при аутоиммунном гастри те уреазный тест, определение антигена H. pylori в кале и дыхательный изотопный тест могут дать ложноотрицательный результат изза низкой кон центрации бактерий в СОЖ [13]. Кроме того, уреаз ный тест в условиях анацидности (при атрофии или длительном приеме ингибиторов протонной пом пы) может дать ложноположительный результат изза колонизации СОЖ уреазаположительными видами бактерий [9] или дрожжей [6].…”

“…The presence of H. pylori in GM was de termined through IgG antibodies against the bacterium. The method was chosen since low bacterial load biopsy urease test, stool antigen test, and 13CUrea breath test can be false negative in autoimmune gastritis pa tients with low acid output [13]. Moreover, bi opsy urease test can be false positive in case of low acid output (related to atrophy or long term treatment by protonpump inhibitors), when GM is colonized with ureasepositive bacteria [9] or yeastlike organisms [6].…”