High-Sensitivity CRP (hs-CRP) Test Kit
Saliva sample · hollow-gold signal amplification · 3-tier visual cardiovascular risk stratification
A high-sensitivity CRP kit built for cardiovascular risk stratification. Using saliva, it upgrades CRP from a binary "is inflammation present" test to a three-tier "how much cardiovascular risk" tool.
Specifications
Per manufacturer's IFU| Product name | High-Sensitivity C-Reactive Protein (hs-CRP) Test Kit |
| Marker | High-sensitivity C-reactive protein (hs-CRP) |
| Sample type | Saliva · 0.1 mL · no fasting, no centrifugation |
| Detection | 0.5 mg/L (blood-equivalent) |
| Reading | Visual colour card · T-line intensity levels 1 / 2 / 3 |
| Time to result | 15 minutes |
| Pack size | 25T / 50T · individually foil-pouched |
| Storage | 4–30°C · ambient transport · 24-month shelf life |
| Registration | Registration in progress |
Test principle
Hollow gold nanoparticles amplify the signal; a high-affinity hs-CRP antibody pair and a saliva-specific chromatographic system stabilise colour development of low-abundance hs-CRP for visual comparison.
Product visuals
From product materials
Kit composition
- hs-CRP test cassette25 / 50 tests · individually foil-pouched
- Saliva swab + collection tubeNon-invasive · no fasting, no centrifugation
- Sample diluentPre-filled tube · ready to use · room-temperature stable
- 3-level colour cardPrinted inside the pack · compare on the spot · no instrument
- Instructions + control cardTwo-level controls included · traceable in-house QC
Procedure
- 1Collect0.1 mL saliva · no fasting required
- 2ApplyDrop into the sample well
- 3WaitTime 15 minutes
- 4ReadGrade visually against the colour card
Result interpretation
A visible C line means the test is valid. Compare T-line intensity against the in-pack levels 1 / 2 / 3 for low / intermediate / high risk. Allow ≥ 2 weeks between two measurements and average them.
Application settings
Add hs-CRP to premium packages as a core cardiovascular screening marker and route positives to specialist care.
Rapid outpatient risk stratification, PCI / statin follow-up, with abnormal results confirmed by venous quantitative assay.
Instrument-free visual self-testing; check risk any time without registration or queuing.
Blood-free, instrument-free screening; record-based screening for hypertension / hyperlipidaemia / diabetes; suitable for mobile vans and community clinics.
Clinical guidelines
- AHA / CDC 2003Three-tier CV risk stratification<1 low · 1–3 intermediate · ≥3 mg/L high
- ACC / AHA 2019 primary preventionRisk enhancement in intermediate riskDecision support at 10-year ASCVD 7.5–20%
- JUPITER trial (NEJM 2008)Statin initiationBenefit in patients with hs-CRP ≥ 2 and normal LDL
- ESC 2024 chronic coronary syndromesResidual inflammation monitoring≥ 2 mg/L · colchicine class IIa
- ACC 2025 statementPCI / statin follow-upBroad hs-CRP screening in primary and secondary prevention
- Metabolic syndrome guidelineMetS / type 2 diabetesCombined model AUC 0.857 · better than single markers
Home self-testing
- 1Hypertension / family historyProactively monitor residual inflammatory risk — 5–10 years of lead time
- 2Sub-health populationNo clear symptoms but low-grade inflammation present — assess periodically
- 3Anti-inflammatory interventionQuantify the effect of anti-inflammatory diet, exercise and omega-3
- 4Long-term statin usersFollow-up efficacy · assess residual risk together with LDL-C
- 5Confirming a positive screeningRe-check at home after a positive institutional screen to avoid a one-off misclassification
Technology barriers
Hollow spherical shell · large surface area · far stronger antibody loading and signal amplification than conventional colloidal gold (patent No. 201710273592.8 / 202111117843.6)
High-affinity hs-CRP antibody pair plus matrix optimisation to remove mucin interference
Built on 400+ real-world samples; tiers map to AHA <1 / 1–3 / ≥3 mg/L
C-line control plus graded T-line intensity — instrument-free visual reading at home
Competitive comparison
Based on publicly available information| Dimension | This product | 进口化学发光（罗氏 / 雅培 / 西门子） | 国产 ELISA 试剂盒 | 海外居家自测产品（Repose / QuikRead go / Everlywell） |
|---|---|---|---|---|
| Sample | Oral saliva | Serum / plasma | Serum | Fingerstick / dried blood spot |
| Collection | Non-invasive saliva | Venous draw | Venous draw | Fingerstick |
| Instrument needed | No · visual colour card | Yes (large CLIA analyser) | Yes (microplate reader) | Yes (reader / mail-in lab) |
| Time to result | 15 min | 30–60 min | 2–3 h | QuikRead go ~3 min; Repose ~15 min; Everlywell 5–8 days |
| Measuring range | 0.5–10 mg/L (blood-equivalent) | 0.3–400 mg/L (Roche cobas) | Kit dependent | QuikRead go 5–200 mg/L |
| Qual / quant | 3-tier semi-quantitative (visual) | Quantitative | Quantitative | Quantitative |
| Setting | Home / primary care / screening / field | Central laboratory | Secondary hospital laboratory | Home (mail-in or instrument) |
| Operator | Anyone (home use) | Laboratory technician | Laboratory technician | Trained personnel |
| Biohazard risk | No blood exposure | Blood exposure | Blood exposure | Blood exposure |
| Registration | Registration in progress | NMPA approved | NMPA approved | Overseas CE / FDA, not registered in China |
This kit combines non-invasive saliva sampling, instrument-free reading, immediate results and home self-testing; no comparable overseas home product currently matches on all four dimensions.
Specifications and guideline references on this page come from the product instructions and published clinical literature; stratification thresholds follow AHA recommendations.