Tarangnan Community Hospital
Clinical Laboratory • Serology Section
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Document No.: WI-S-002-A-V0 | CONTROLLED COPY Do not copy or remove |
| Parent document: SOP-S-002, Sections 5.3–5.7 | Version: V0 | ||
| Applies to: Medical Technologists and Laboratory Aides | Effective date: MM-DD-YYYY | Supersedes: None | ||
HBsAg Rapid Qualitative Immunoassay & Confirmatory Referral Bench Card
Two Authorized TCH Methods • Duplicate Retesting of Reactives • SPH / SACCL Confirmatory Send-Out Protocol
BIOSAFETY: Wear gloves; discard droppers/cassettes into biohazard/sharps waste; decontaminate spills per waste SOP.
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Equilibration & Inspection: Bring refrigerated serum and foil pouch to room temperature (15–30 °C) for 15–30 min. Check desiccant: for STANDARD Q, Yellow = Valid; Green = Discard. Label cassette with 2 patient identifiers. SOP 5.2/5.415–30 min
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Method-Specific Specimen Loading:
• Method A (AllTest/Trimera REF IHBSG-402): Dispense exactly 3 drops (~75 µL) serum into well (S). No chase buffer.
• Method B (SD BIOSENSOR STANDARD Q REF QHBS01G): Dispense exactly 100 µL serum (black line of dropper or pipette) into well (S). No chase buffer. SOP 5.3/5.4/5.5 -
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Timing & Incubation: Start dedicated digital timer immediately upon sample loading. Keep cassette horizontal and undisturbed on bench. SOP 5.3/5.4
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Method-Specific Reading Windows:15–30 min
• Method A: Read results between 15 and 30 minutes.
• Method B: Read result at 15–30 minutes; do not read after 30 minutes. SOP 5.3/5.4/5.5 -
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STOP / STRICT CUTOFF Maximum Reading Limit: DO NOT interpret results after 30 minutes for either method. Evaporation artifacts and non-specific binding cause false-positive lines. SOP 5.3/5.4/5.5STOP > 30 min
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Duplicate Retest of Reactives: Any initial reactive or faint T line MUST be retested in duplicate using fresh cassettes from the original patient tube. If either retest is reactive, confirm reactive screening status. SOP 5.7.2
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SPH / SACCL Confirmatory Referral: Report preliminary screening result: "Reactive (Initial Screening Only — Referred for Confirmation)". Aliquot 1.0–1.5 mL clear serum, store at 2–8 °C, package in triple packaging with cool packs, and dispatch to Samar Provincial Hospital (SPH) or SACCL per LAB-QM-PRE-002. Notify clinician and report under RA 11332. SOP 5.7.2
External Quality Control (ISO 15189:2022 §7.3.7)
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).
REACTIVE (Positive)
Both C & T lines visible. Perform duplicate retest.
FAINT REACTIVE
Any visible T line is Reactive. Retest in duplicate.
NON-REACTIVE
C line only. Report Non-Reactive with standard disclaimer.
INVALID
No C line. Test VOID. Discard and repeat with new device.
Method Separation Table (SOP 5.5)
| Parameter | Method A (AllTest) | Method B (STANDARD Q) |
|---|---|---|
| Catalog No. | REF IHBSG-402 | REF QHBS01G |
| Serum Vol. | 3 drops (~75 µL) | 100 µL (black line) |
| Buffer | None for serum | None for serum |
| Desiccant | Visual check | Yellow = Valid; Green = Discard |
| Read Time | 15 to 30 min | 15 to 30 min (do not read after 30 min) |
| Max Cutoff | Do not read > 30 min | Do not read > 30 min |
Confirmatory Referral Checklist (SOP 5.7.2)
- Referral Facility: Samar Provincial Hospital (SPH) or SACCL.
- Specimen Aliquot: Minimum 1.0–1.5 mL clear serum.
- Storage & Cold Chain: 2 to 8 °C in triple packaging with ice packs per LAB-QM-PRE-002.
- Documentation: External Referral Logbook + Transmittal Form.
- Statutory Notification: Report reactive hepatitis under RA 11332.
| Prepared by: Chief Medical Technologist Signature / Date: ____________________ |
Reviewed by: Pathologist Signature / Date: ____________________ |
Approved by: Hospital Director Signature / Date: ____________________ |