Tarangnan Community Hospital Clinical Laboratory • Clinical Microscopy	Document No.: WI-CM-005-A-V0	CONTROLLED COPY Do not copy or remove
	Parent document: SOP-CM-005, Sections 5.2–5.6 \| Version: V0
Applies to: Medical Technologists and Laboratory Aides \| Effective date: MM-DD-YYYY \| Supersedes: None

Stool Rapid Tests (RightSign H. pylori Antigen & Immunochemical FOBT) Card

Standardized fecal extraction, rapid lateral-flow testing, medication hold governance, and result reading

BIOSAFETY: Wear gloves; discard used cassettes, droppers, and extraction tubes into biohazard/sharps waste; decontaminate spills per waste SOP.

Kit Check & External QC (Both Parts)

Expiry & Storage: Verify kit expiry date and storage condition per kit insert before testing; do not use expired kits.
External QC: Run kit positive/negative controls with each new lot/shipment or at the SOP-defined frequency; log lot number and expiry (ISO 15189:2022 §7.3.7).

Part A: RightSign Helicobacter pylori Stool Antigen (REF HPG-C61)

A-1
Spiral Wand Sampling & Extraction: Stab applicator wand into stool at 3 to 6 sites (~50 mg feces in spiral grooves; do NOT scoop). Reinsert wand into extraction tube, tighten cap, shake vigorously for 20 s, and stand for 2 min. SOP 5.2.4
Stand 2 min
A-2
Cassette Inoculation & Reading: Break dropper tip. Invert tube vertically over sample well (S) of labeled RightSign cassette. Dispense exactly 2 drops (approximately 80 µL). Start timer. Read at 10 minutes. SOP 5.2.4
10 min
A-3
STOP / STRICT CUTOFF H. pylori Maximum Reading Limit: DO NOT read or interpret after 20 minutes. Late drying causes false-positive artifacts. If fluid fails to migrate within 2 min, centrifuge extraction tube at 1000 × g (confirm the rpm on your centrifuge's conversion chart) for 3 min and retest with a new cassette. SOP 5.2.4
STOP > 20 min

Part B: Qualitative Immunochemical Fecal Occult Blood Test (iFOBT / FIT)

B-1
FOBT Wand Sampling & Extraction: Insert FOBT applicator wand into stool at 3 to 6 random sites to coat spiral grooves. Insert into FOBT buffer tube, tighten cap, shake vigorously for 20 s, and stand for 2 min to settle debris. SOP 5.3.3
Stand 2 min
B-2
FOBT Inoculation & Reading: Break dropper tip. Invert vertically over sample well (S). Dispense 2 to 3 drops (approximately 80–100 µL) of extracted buffer. Start timer. Read at 5 to 10 minutes. SOP 5.3.3
5–10 min
B-3
STOP / STRICT CUTOFF FOBT Maximum Reading Limit: DO NOT read or interpret after 10 minutes. Prolonged incubation produces false-positive ghost lines. SOP 5.3.3
STOP > 10 min

POSITIVE (Reactive)

Both C & T lines visible (active H. pylori or human Hb ≥ 50 ng/mL)

NEGATIVE (Non-Reactive)

Control line C only. T line completely absent.

INVALID

Control line C absent. Test VOID. Repeat with fresh cassette.

PPIs & Bismuth: Must be off for at least 2 weeks (omeprazole, pantoprazole, lansoprazole, bismuth subsalicylate). Suppression of bacterial density causes false negatives.
Antibiotics: Must be off for at least 4 weeks before testing.
Test of Cure: Schedule ≥ 4 weeks after finishing eradication therapy.

No Dietary Restrictions (FIT advantage): Monoclonal anti-human hemoglobin is unaffected by red meat, turnips, or vitamin C (unlike legacy guaiac tests).
Medication Hold (per kit insert — verify): Withhold heavy NSAIDs, aspirin, and alcohol for 48 h before collection; these can irritate the GI tract and cause bleeding the test will detect.
Collection Precautions: Defer collection during active menses (wait 3 days post-menses), with bleeding hemorrhoids, or with hematuria.
Lower GI Specific: Upper GI blood globin is degraded by proteases.
Specimen Acceptance: Clean dry container; no toilet-water or urine contamination; minimum sample per insert; test fresh or refrigerate ≤3 days per insert (verify).

Prepared by: Chief Medical Technologist
Signature / Date: ____________________

Reviewed by: Pathologist
Signature / Date: ____________________

Approved by: Hospital Director
Signature / Date: ____________________