Ⅰ

Participant & Visit Information

Participant ID*

Format: SITE-PARTICIPANT (e.g. 1001-001)

Collection Date*

Has the participant fasted for ≥ 4 hours?*

Yes — fasted ≥ 4 h No — fasted < 4 h

Assessor Initials*

Acid-Suppressing Medication*

Confirm that the participant has not taken any proton pump inhibitor, H2 receptor antagonist, or potassium-competitive acid blocker for at least 14 days prior to this visit.

Confirmed — ≥14-day washout

Antibiotic use within the past 28 days?*

No Yes

1

Step 1 — Pepsinogen Panel

PGI

µg/L

PGII

µg/L

PGI:PGII Ratio AUTO

ratio

2

Step 2 — Fasting G-17 (G17b)

Fasting G-17 (G17b)*

pmol/L

–

Record the fasting G-17b value. Normal range: 1–7 pmol/L. Proceed to H. pylori assessment.

3

Step 3 — H. pylori IgG (HpAb)

HpAb <30 EIU = negative*

EIU

–

<30 EIU → Screen assessment complete
≥30 EIU → Confirmatory test required — UBT or SAT

⚠ H. pylori Seropositive — Confirmatory Testing Required

HpAb ≥ 30 EIU. Positive serology may reflect past exposure (serofast state). Perform a confirmatory test to determine whether active infection is present.

Confirmatory Test Method*

Urea Breath Test (UBT) Stool Antigen Test (SAT)

Confirmatory Test Result*

Negative — active infection absent Positive — active infection confirmed

✓

Analyte Summary — EDC Record

Step	Analyte	Observed Value	Reference / Threshold	Status

REVIVE GastroScreen