Serological Biomarker Panel (GastroPanel®): A Test for Non-Invasive Diagnosis of Dyspeptic Symptoms and for Comprehensive Detection of Helicobacter pylori Infection

Abstract

The two major risk factors of Gastric Cancer (GC) are Helicobacter pylori (HP) infection and Atrophic Gastritis (AG) It is currently possible to diagnose HP-infection and AG by using serological testing with a panel of biomarkers (GastroPanel ® , Biohit Oyj, Finland): Pepsinogen I (PGI), Pepsinogen II (PGII), and HP-antibodies. In this review, an introduction is made to the GastroPanel ® test as the first non-invasive diagnostic tool for: i) Dyspeptic symptoms, ii) Screening of asymptomatic subjects for the risks of GC, iii) A comprehensive diagnosis of HP-infection.GastroPanel ® test is based on stomach physiology both in health and disease. Accordingly, pepsinogen levels and their ratio is decreased in corpus atrophy (AGC), accompanied by elevated G-17b (basal) G-17b level also sensitively responds to gastric acid output, being low with high acid output and high when the stomach is acid-free (due to PPI-treatment or AGC) In Antrum Atrophy (AGA), G-17b is low and, importantly, does not respond to protein stimulation (G-17s), because the G-cells are disappeared.The results of GastroPanel ® test are interpreted by a special software (GastroSoft ® ) identifying 8 diagnostic marker profiles. Of those, four (profiles 1, 2, 3, and 8) represent purely functional disorders (of acid output), while three others specify structural abnormalities (profiles 5, 6, and 7 for AGC, AGA, and AGpan, respectively) the remaining (profile 4) is typical to HPinfection, with three possible outcomes: a) Active HPinfection, b) Successful eradication, and c) Failed eradication.GastroPanel ® test has been validated in both clinical and screening settings. The entire published literature was subjected to systematic review and meta-analysis, including 27 eligible studies that comprise almost 9.000 patients. GastroPanel ® was shown to perform better in diagnosis of AGC than AGA, with 70.2% vs. 51.6% pooled SE, and 93.9% vs. 84.1% pooled SP, respectively. This first meta-analysis corroborates the recently launched statement of 16 international experts, advocating the use of this non-invasive serological test as the first-line diagnostic tool for dyspeptic symptoms and for screening of the risks of GC among asymptomatic subjects.The two most commonly used HP tests (UBT and SAT) are prone to false-negative results in conditions with decreased bacterial loads in the stomach: 1) Use of PPI medication; 2) Use of antibiotics; 3) Bleeding peptic ulcer; 4) AG; 5) GC; 6) MALT lymphoma, and 7) Partial gastrostomy. False-positive results do occur in cases where urease-producing bacterial species are colonizing an acid-free stomach (AG or PPI users) it is mandatory that these serious limitations in the use of UBT and SAT are properly acknowledged while these two HP tests are being promoted. Given that this bacteria is the single most important risk factor of GC, it is time to move a step forward also in the diagnosis of HP-infections, and start using the test (GastroPanel ® ) that is: i) Free from the shortcoming of the conventional HP tests, an...

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

“…In general, gastric bacterial overgrowth even with bacterial and fungal bezoars is a constant phenomenon in an acid-free stomach (28). In the late 1990s, it was demonstrated that the number of microbes in gastric mucosa is comparable to that of gastric juice (35), and these non-Hp bacteria are also embedded in the mucus and even in close contact with the gastric epithelium, similarly to Hp (36)(37)(38).…”

“…GastroPanel ® was introduced in a series of recent communications (37,38,(43)(44)(45). The test is composed of enzyme-linked immunosorbent assays (ELISA) of three biomarkers: pepsinogen I (PGI), pepsinogen II (PGII) and gastrin-17 (G-17), combined with an ELISA assay of Hp (IgG) antibodies, all being measured from the same serum/plasma sample (43)(44)(45).…”

“…The risk of GC is increased (5-fold) when the PGI/PGII ratio is low (41,52,55,65,(71)(72)(73)(74)(75)(76). In GastroPanel ® test, decreased PGI and low PGI/PGII ratio, along with elevated G-17 is an unfailing hallmark of AGC (37,38,44,45,50,51). An elevated PGII level as a stand-alone marker reflects mucosal inflammation, the highest values usually being detected in Hp-associated active gastritis (37,38).…”

“…In GastroPanel ® test, decreased PGI and low PGI/PGII ratio, along with elevated G-17 is an unfailing hallmark of AGC (37,38,44,45,50,51). An elevated PGII level as a stand-alone marker reflects mucosal inflammation, the highest values usually being detected in Hp-associated active gastritis (37,38). Since the Hp antibody level remains elevated for several months after successful eradication, PGII is also useful in the evaluation of a successful Hp eradication (41,44,45).…”

Current View on Autoimmune Gastritis

“…Iron deficiency anemia, which is often present in patients with AIG, should be identified by levels of hemoglobin, mean corpuscular volume (MCV), serum iron, ferritin, total iron-binding capacity (TIBS) and serum transferrin receptor (TfR). In patients with suspected carcinoid tumor transformation the measurement of chromogranin A, which is secreted by the ECL cells, can be useful, although it shows low specificity (23%) and false-positive results in patients with inflammatory bowel disease, renal insufficiency and other conditions [4, 23, [35][36][37][38][39][40][41][42][43][44][45].…”