CRP / Procalcitonin (CRP + PCT) Combo Test Kit
One saliva sample · two markers simultaneously · rapid screening in 3–15 minutes
A next-generation non-invasive POCT inflammation test. One saliva sample measures CRP and PCT together, supporting infection differentiation, antibiotic decisions and dynamic therapy monitoring.
Specifications
Per manufacturer's IFU| Product name | C-Reactive Protein / Procalcitonin Combo Test Kit (hollow-gold method) |
| Markers | C-reactive protein (CRP) + procalcitonin (PCT) |
| Sample type | Human oral saliva · no blood draw |
| Time to result | 3–15 minutes |
| Reading | Visual reading · dual test lines + control line |
| Storage | Sealed at 4–30°C · ambient transport |
| Qual / quant | Qualitative / semi-quantitative |
| Registration | Registration in progress |
Test principle
Hollow gold nanoparticles provide a larger surface area and higher antibody loading, producing stronger signal amplification in the chromatographic system; a proprietary conjugation process stabilises detection of low-abundance CRP / PCT in saliva.
Product visuals
From product materials
Kit composition
- Test cassetteDual CRP and PCT test lines plus a control line
- Sample bufferDilutes and stabilises the saliva sample
- Collection swabDedicated oral saliva collection
- DesiccantMaintains cassette stability
- Instructions for useOperating and result-interpretation guide
Procedure
- 1CollectNon-invasive oral saliva collection
- 2ApplyMix sample with buffer and apply to the well
- 3WaitReact at room temperature for 3–15 minutes
- 4ReadObserve the C / T1 / T2 line pattern
Result interpretation
This is a screening tool with qualitative / semi-quantitative results. PCT thresholds and phenotype calls must be interpreted by a physician together with symptoms, history and other investigations.
Application settings
Triage within 15 minutes at the onset of cold or fever, easing anxiety and outpatient load.
Rapid differentiation at first contact in community and township facilities, supporting prescribing decisions.
Rapid screening in fever clinics and paediatric emergency without blood exposure, reducing cross-infection risk.
The PCT inflection point guides when to stop therapy, avoiding prolonged empirical treatment.
Clinical guidelines
- SCCM / ESICM 2024 sepsisSepsis 1-hour bundlePCT trend guides rapid antibiotic de-escalation
- China sepsis guideline 2024Bacterial infection thresholdPCT ≥ 0.5 ng/mL strongly suggests bacterial infection
- IDSA / ATS 2019 CAPCommunity-acquired pneumoniaCombo testing supports bacterial / viral / atypical differentiation
- WHO antimicrobial stewardshipReducing unnecessary prescriptionsCombo testing reduced antibiotic prescribing by about 35%
- Antimicrobial guideline 2023Tiered managementCombo testing specified as a basis for tiered management
- CHINET resistance surveillanceEarly resistance warningPersistent abnormality correlates with resistance risk
Home self-testing
- 1Cold and fever · flu seasonDistinguish bacterial from viral at the onset of sore throat or fever
- 2Chronic disease with infectionPCT trend supports de-escalation and avoids prolonged empirical therapy
- 3Households with elderly / children15-minute triage at the onset of cough or sore throat
- 4During an antibiotic courseMonitor response · the PCT inflection point guides stopping
- 5Post-operative recoveryEarly detection of wound infection plus CRP trend
Technology barriers
Hollow-gold preparation and use patents (No. 201710273592.8 / 202111117843.6)
Reduces saliva background interference; two markers on one cassette without cross-reactivity
Established on 400+ real-world samples
Lower detection-sensitivity requirement with stable lot-to-lot consistency
Competitive comparison
Based on publicly available information| Dimension | This product | 血液 POCT 类产品（万孚生物、微点生物等） | 血液生化 / 免疫分析仪（迈瑞、东方生物等） |
|---|---|---|---|
| Sample | Oral saliva | Whole blood / serum / plasma | Venous serum / plasma |
| Collection | Non-invasive saliva | Fingerstick or venous draw | Venous draw |
| Instrument needed | No (visual reading) | Yes (fluorescence / colloidal-gold reader) | Yes (large chemistry / immunoassay analyser) |
| Time to result | 3–15 min | 10–20 min (excluding collection) | 2–4 h |
| Markers | CRP + PCT combo | PCT / CRP combo (mostly quantitative) | CRP, PCT, SAA, IL-6 and more |
| Qual / quant | Qualitative / semi-quantitative | Quantitative | Quantitative |
| Setting | Home / primary care / field | Hospital / clinic | Hospital laboratory |
| Biohazard risk | No blood exposure | Blood exposure | Blood exposure |
| Patient compliance | Child / elderly friendly | Children resist | Must visit facility |
| Registration | Registration in progress | NMPA / CE approved | NMPA approved |
While retaining the speed advantage of POCT, this kit replaces blood with saliva — delivering infection screening that is genuinely non-invasive, accessible and affordable.
Specifications and guideline references come from the product instructions and published authoritative guidelines; the reduction in antibiotic prescribing is cited from published studies and varies by population and setting.