Immunoanalyser 1

The Immunoanalyser 1 is designed for processing and analysing test kits. These kits include biomarkers for various health conditions such as cardiovascular diseases, renal function, inflammation, fertility, diabetes mellitus, bone metabolism, tumours, and thyroid function. The analyser is utilised to measure the concentration of biomarkers in human whole blood, serum, plasma, urine, nasal swab, or saliva samples. The results obtained can assist in clinical diagnosis in laboratory settings.

Tests offered: hs-CRP+CRP PCT, Ferritin, D dimer ,IL-6, CEA, AFP, Cardiac troponin (cTnI), CK-MB, NT pro-BNP, TSH, fT4, fT3, HCG+β, AMH, FSH, LH, Prolactin, Progestogen, Anti-CCP, RF, cys C, Microalbumin, NGAL, ß2-MG, HbA1C, h. pylori, Testosterone, ASO, IgE, Vitamin D (25-OH-VD)

Certification: CE Certified, NMPA (Chinese FDA) certified, ISO13485 

Performance Characteristics:

Tests OfferedSpecimenPerformance
hs-CRP+CRPWhole Blood / Serum / Plasma / Fingertip BloodMeasuring Range: 0.5~200.0 mg/L
Lower Detection Limit: ≤ 0.5 mg/L
Within-Run Precision: ≤ 10%
Between-Run Precision: ≤ 15%
PCTWhole Blood / Serum / PlasmaMeasuring Range: 0.05~50.0 ng/ml
Lower Detection Limit: ≤ 0.05 ng/ml
Within-Run Precision: ≤ 10%
Between-Run Precision: ≤ 15%
FerritinSerum / PlasmaMeasuring Range: 0.5~1000.0 ng/mL
Lower Detection Limit: ≤ 0.5 ng/mL
Within-Run Precision: ≤ 10%
Between-Run Precision: ≤ 15%
D dimerWhole Blood / PlasmaMeasuring Range: 0.10 ~ 10.00 mg/L
Lower Detection Limit: ≤ 0.10 mg/L
Within-Run Precision: ≤ 10%
Between-Run Precision: ≤ 15%
IL-6Whole Blood / Serum / Plasma / Peripheral BloodMeasuring Range: 1.5 ~ 4000.0 pg/mL
Lower Detection Limit: ≤ 1.5 pg/mL
Within-Run Precision: ≤ 10%
Between-Run Precision: ≤ 15%
CEASerum / PlasmaMeasuring Range: 2.0 ng/mL ~ 500.00 ng/mL
Lower Detection Limit: ≤ 2.0 ng/mL
Within-Run Precision: ≤ 10%
Between-Run Precision: ≤ 15%
AFPSerum / PlasmaMeasuring Range: 2.0 ~ 500.0 ng/mL
Lower Detection Limit: ≤ 2.0 ng/mL
Within-Run Precision: ≤ 10%
Between-Run Precision: ≤ 15%
Cardiac troponin (cTnI)Whole Blood / Serum / PlasmaMeasuring Range: 0.10 ~ 50.00 ng/ml
Lower Detection Limit: ≤ 0.10 ng/ml
Within-Run Precision: ≤ 10%
Between-Run Precision: ≤ 15%
CK-MBWhole Blood / Serum / PlasmaMeasuring Range: 2.50 ~ 80.00 ng/ml
Lower Detection Limit: ≤ 2.50 ng/ml
Within-Run Precision: ≤ 10%
Between-Run Precision: ≤ 15%
NT pro-BNPWhole Blood / Serum / PlasmaMeasuring Range: 100 ~ 35000 pg/ml
Lower Detection Limit: ≤ 100 pg/ml
Within-Run Precision: ≤ 10%
Between-Run Precision: ≤ 15%
TSHSerum / PlasmaMeasuring Range: 0.10 μlU/mL ~ 50.00 μlU/mL
Lower Detection Limit: 0.10 μlU/mL
Within-Run Precision: ≤ 10%
Between-Run Precision: ≤ 15%
fT4Whole Blood / Serum / PlasmaMeasuring Range: 0.30-100.0 pmol/L
Lower Detection Limit: ≤ 0.3 pmol/L
Within-Run Precision: ≤ 10%
Between-Run Precision: ≤ 15%
fT3Whole Blood / Serum / PlasmaMeasuring Range: 0.40 pmol/L ~ 50.00 pmol/L
Lower Detection Limit: ≤ 0.40 pmol/L
Within-Run Precision: ≤ 10%
Between-Run Precision: ≤ 15%
HCG+βSerum / PlasmaMeasuring Range: 5.0~100000.0 mlU/ml
Lower Detection Limit: ≤ 5.0 mlU/ml
Within-Run Precision: ≤ 10%
Between-Run Precision: ≤ 15%
AMHSerum / PlasmaMeasuring Range: 0.10 ~ 20.00 ng/mL
Lower Detection Limit: ≤ 0.10 ng/mL
Within-Run Precision: ≤ 10%
Between-Run Precision: ≤ 15%
FSHSerum / PlasmaMeasuring Range: 0.20 ~ 150.00 mlU/mL
Lower Detection Limit: ≤ 0.20 mlU/mL
Within-Run Precision: ≤ 10%
Between-Run Precision: ≤ 15%
LHSerum / PlasmaMeasuring Range: 0.20 ~ 150.00 mlU/mL
Lower Detection Limit: ≤ 0.20 mlU/mL
Within-Run Precision: ≤ 10%
Between-Run Precision: ≤ 15%
ProlactinSerum / PlasmaMeasuring Range: 0.50 ng/mL ~ 200.00 ng/mL
Lower Detection Limit: ≤ 0.50 ng/mL
Within-Run Precision: ≤ 10%
Between-Run Precision: ≤ 15%
ProgestogenSerum / PlasmaMeasuring Range: 0.10 ng/mL ~ 40.00 ng/mL
Lower Detection Limit: ≤ 0.10 ng/mL
Within-Run Precision: ≤ 10%
Between-Run Precision: ≤ 15%
Anti-CCPWhole Blood / Serum / PlasmaMeasuring Range: 10.0 ~ 400.0 U/mL
Lower Detection Limit: ≤ 10.0 U/mL
Within-Run Precision: ≤ 10%
Between-Run Precision: ≤ 15%
RFWhole Blood / Serum / PlasmaMeasuring Range: 0.50~10.00 mg/L
Lower Detection Limit: ≤ 0.50 mg/L
Within-Run Precision: ≤ 10%
Between-Run Precision: ≤ 15%
cys CWhole Blood / Serum / PlasmaMeasuring Range: 0.50~10.00 mg/L
Lower Detection Limit: ≤ 0.50 mg/L
Within-Run Precision: ≤ 10%
Between-Run Precision: ≤ 15%
MicroalbuminUrineMeasuring Range: 10.0~200.0 mg/L
Lower Detection Limit: ≤ 10.0 mg/L
Within-Run Precision: ≤ 10%
Between-Run Precision: ≤ 15%
NGALSerum / UrineMeasuring Range: 50.0~5000.0 ng/ml
Lower Detection Limit: ≤ 50.0 ng/ml
Within-Run Precision: ≤ 10%
Between-Run Precision: ≤ 15%
ß2-MGWhole Blood / Serum / PlasmaMeasuring Range: 0.50~20.00 mg/L
Lower Detection Limit: ≤ 0.50 mg/L
Within-Run Precision: ≤ 10%
Between-Run Precision: ≤ 15%
HbA1CWhole BloodMeasuring Range: 2%-14%
Lower Detection Limit: ≤2%
Within-Run Precision: ≤5%
h. pyloriFaecalMeasuring Range: 1.0 ng/mL ~ 200.0 ng/mL
Lower Detection Limit: ≤ 1.0 ng/mL
Within-Run Precision: ≤ 10%
Between-Run Precision: ≤ 15%
TestosteroneSerum / PlasmaMeasuring Range: 0.1 ng/mL ~ 16.0 ng/mL
Lower Detection Limit: ≤ 0.10 ng/mL
Within-Run Precision: ≤ 15%
Between-Run Precision: ≤ 15%
ASOWhole Blood / Serum / PlasmaMeasuring Range: 60.0 ~ 1370.0 IU/mL
Lower Detection Limit: ≤ 40.0 IU/mL
Within-Run Precision: ≤ 10%
Between-Run Precision: ≤ 15%
IgEWhole Blood / Serum / PlasmaMeasuring Range 1.00 ~ 2000.00 IU/mL
Lower Detection Limit ≤ 1.00 IU/mL
Within-Run Precision ≤ 10%
Between-Run Precision ≤ 15%
Vitamin D (25-OH-VD)Whole Blood / Serum / Plasma / Capillary BloodMeasuring Range 8.00 ~ 70.00 ng/mL
Lower Detection Limit ≤ 8.00 ng/mL
Within-Run Precision ≤ 10%
Between-Run Precision ≤ 15%
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