YSENZDX

Human IVD · FIA POCT

FIA POCT test menu

Reagent portfolio for YD-F10, YD-F100, YD-F1600 and YD-F6000. Assays include CRP, PCT, SAA, IL-6, cTnI, NT-proBNP, BNP, D-dimer, AFP, CEA, PSA, HbA1c, TSH, and infectious-disease tests. A listing does not by itself mean the assay is cleared for every instrument or every market.

POCT reagent specifications

YD-F10 uses a dedicated reagent configuration. Confirm the matched reagent, calibration data and registration documents assay by assay. Reagents are supplied in 25-test packs. Reseal the foil pouch after opening and keep the desiccant.

Sample types: WB whole blood, FTB fingertip blood, S serum, P plasma, U urine.

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FIA POCT reagent specifications
ProductSample volumeDilution volumeSample typeReaction timeDetection rangeCut-offCertification
CRP10 µL WB/FTB5 µL S/P75 µLWB/FTB/S/P3 min0.5–200 mg/LhsCRP <1 mg/LCRP <10 mg/LCE
PCT100 µL75 µLWB/S/P12 min0.25–100 ng/mL<0.5 ng/mLCE
SAA10 µL WB/FTB5 µL S/P75 µLWB/FTB/S/P3 min3–200 mg/L<10 mg/LCE
CRP/SAA10 µL WB/FTB5 µL S/P75 µLWB/FTB/S/P3 minCRP: 0.5–200 mg/LSAA: 3–200 mg/LCRP <10 mg/LSAA <10 mg/LCE
HBP75 µL75 µLP12 min6–300 ng/mL<12.0 ng/mLCE
CCP20 µL WB10 µL S/P75 µLWB/S/P10 min5–640 RU/mLRefer to user manualCE
RF/ASO/CRP10 µL75 µLS10 minRF: 10–120 IU/mLASO: 30–600 IU/mLCRP: 1–100 mg/LRF <20 IU/mLASO <200 IU/mLCRP <10 mg/LCE
RF10 µL75 µLWB/S/P10 minRF: 10–120 IU/mLRF <20 IU/mLCE
ASO10 µL75 µLWB/S/P10 minASO: 30–600 IU/mLASO <200 IU/mLCE
IL-675 µL75 µLWB/S/P12 min3–4000 pg/mL<7 pg/mLCE
PCT/IL-675 µL75 µLWB/S/P12 minPCT: 0.06–100 ng/mLIL-6: 3.5–4000 pg/mLPCT <0.1 ng/mLIL-6 <7 pg/mLCE
cTnI75 µL75 µLWB/S/P12 min0.05–50 ng/mL<0.1 ng/mLCE
CK-MB75 µL75 µLWB/S/P12 min0.3–100 ng/mL<6 ng/mLCE
Myo75 µL75 µLWB/S/P12 min5–1000 ng/mL<100 ng/mLCE
D-D100 µL WB75 µL P75 µLWB/P5 min0.05–10 mg/L<0.5 mg/LCE
NT-proBNP150 µL WB100 µL S/P75 µLWB/S/P12 min100–45000 pg/mL<75 years: <300 pg/mL≥75 years: <450 pg/mLCE
H-FABP75 µL75 µLS/P12 min2–150 ng/mL<7 ng/mLCE
cTnI/CK-MB/Myo75 µL75 µLWB/S/P15 mincTnI: 0.05–50 ng/mLCK-MB: 1–100 ng/mLMyo: 5–600 ng/mLcTnI: <0.1 ng/mLCK-MB: <6 ng/mLMyo: <100 ng/mLCE
cTnI/NT-proBNP/D-D100 µL100 µLWB/P15 mincTnI: 0.1–50 ng/mLNT-proBNP: 100–45000 pg/mLD-D: 0.05–10 mg/LRefer to user manualCE
ST275 µL75 µLWB/S/P12 min3–200 ng/mL≤35 ng/mLCE
NT-proBNP/ST275 µL75 µLWB/S/P12 minNT-proBNP: 100–45000 pg/mLST2: 3–200 ng/mLRefer to user manualCE
Lp-PLA275 µL75 µLWB/S/P5 min10–800 ng/mL<175 ng/mLCE
cTnT75 µL75 µLWB/S/P12 min0.03–10 ng/mL<0.1 ng/mLCE
BNP75 µL75 µLWB/P12 min5–5000 pg/mL<100 pg/mLCE
hs-cTnI75 µL75 µLWB/S/P10 min12.2–50000 ng/LMale: <45 ng/LFemale: <35 ng/LCE
CPP75 µL75 µLWB/S/P12 min31.25–2000 pg/mL<70 pg/mLCE
GDF-1575 µL75 µLWB/S/P12 min400–20000 pg/mLRefer to user manualCE
AFP75 µL75 µLS/P12 min5–1000 ng/mL<20 ng/mLCE
t-PSA100 µL100 µLWB/S/P12 min2–100 ng/mL<4 ng/mLCE
CEA75 µL75 µLS/P12 min2.5–600 ng/mL<5 ng/mLCE
PG I75 µL75 µLS12 min10–300 ng/mL70–200 ng/mLCE
PG II75 µL75 µLS12 min5–100 ng/mL<15 ng/mLCE
FOB6 fresh fecal positions2–3 drops(70–100 µL)Fecal10 min50–1200 ng/mL<100 ng/mL (20 µg/g feces)CE
S100β100 µL100 µLWB/S/P15 min0.05–10 ng/mL<0.2 ng/mLCE
VEGF100 µL100 µLWB/S/P15 min50–3200 pg/mL<160 pg/mLCE
G-1775 µL75 µLWB/S/P12 min0.5–320 pmol/L1–7 pmol/LCE
PGI+PGII75 µL75 µLS12 minPGI: 10–300 ng/mLPGII: 5–100 ng/mLPGI: 70–200 ng/mLPGII: <15 ng/mLCE
CA12575 µL75 µLWB/S/P12 min10–2000 U/mL<35 U/mLCE
CA15-310 µL75 µLWB/S/P12 min5–300 U/mL<26.2 U/mLCE
CA19-975 µL75 µLWB/S/P12 min8–1000 U/mL<27 U/mLCE
Cys C10 µL75 µLS/P10 min0.2–10 mg/L<1.2 mg/LCE
β2-MG5 µL75 µLS/P10 min0.1–18 mg/L1–3 mg/LCE
NGAL10 µL75 µLS10 min10–3000 ng/mL<150 ng/mLCE
MAU5 µL75 µLU5 min2–300 mg/L<20 mg/LCE
HbA1c5 µL75 µLWB6 min4.0–15.0%4–6%CE
ADPN10 µL75 µLWB/S/P10 min2.0–40 µg/mL2.6–12.5 µg/mLCE
MP IgM10 µL S/P20 µL WB75 µLWB/S/P10 min5–160 RU/mLRefer to user manualCE
MP IgG10 µL S/P20 µL WB75 µLWB/S/P10 min5–160 RU/mLRefer to user manualCE
Cpn IgM10 µL S/P20 µL WB75 µLWB/S/P10 min5–160 RU/mLRefer to user manual
SARS-CoV-275 µL100 µLWB/S/P15 minQualitativeRefer to user manualCE
Cpn IgG10 µL S/P20 µL WB75 µLWB/S/P10 min5–160 RU/mLRefer to user manual
MP—3–4 drops(100 µL)Oropharyngeal swab15 minQualitativeNegative: result <1.0Positive: result ≥1.0CE
Cpn—3–4 drops(100 µL)Oropharyngeal swab15 minQualitativeNegative: result <1.0Positive: result ≥1.0
Adv—3–4 drops(100 µL)Nasopharyngeal swab10 minQualitativeNegative: result <1.0Positive: result ≥1.0CE
RSV—3–4 drops(100 µL)Nasopharyngeal swab10 minQualitativeNegative: result <1.0Positive: result ≥1.0CE
Strep A—3–4 drops(100 µL)Oropharyngeal swab10 minQualitativeNegative: result <1.0Positive: result ≥1.0CE
Influenza A+B—3–4 drops(100 µL)Nasopharyngeal swab10 minQualitativeNegative: result <1.0Positive: result ≥1.0CE
H. pylori Ab75 µL100 µLWB/S/P15 minUrease: 10–320 RU/mLVacA: 5–80 RU/mLCagA: 7.5–120 RU/mLUrease: <20.0 RU/mLVacA: <10.0 RU/mLCagA: <15.0 RU/mLCE
Dengue NS175 µL75 µLWB/S/P12 minQualitativeNegative: result <1.0Positive: result ≥1.0CE
Dengue IgM/IgG75 µL75 µLWB/S/P12 minQualitativeRefer to user manualCE
HBsAb100 µL100 µLWB/S/P15 min10 mIU/mL–1000 mIU/mL<10 mIU/mL
Total β-HCG100 µL100 µLS15 min25–10000 mIU/mL<25 mIU/mLCE
T375 µL75 µLS15 minMix thoroughly for 5 min0.61–9.22 nmol/L1.23–3.07 nmol/LCE
T475 µL75 µLS15 minMix thoroughly for 5 min12.87–310 nmol/L66–181 nmol/LCE
TSH75 µL75 µLS15 min0.1–100 mIU/L0.3–4.2 mIU/LCE
FT475 µL75 µLS15 minMix thoroughly for 1 min6.0–120 pmol/L12–22 pmol/LCE
FT375 µL75 µLS15 minMix thoroughly for 1 min2.0–50 pmol/L3.1–7.0 pmol/LCE
FSH75 µL75 µLWB/S/P15 min1–150 mIU/mLRefer to user manualCE
LH75 µL75 µLWB/S/P15 min1–150 mIU/mLRefer to user manualCE
HCG60 µL75 µLS15 min10–200000 mIU/mL<10 mIU/mLCE
AMH75 µL75 µLWB/S/P12 min0.1–16 ng/mLRefer to user manualCE
Prog75 µL75 µLWB/S/P15 min1–60 ng/mLRefer to user manualCE
Testo75 µL75 µLWB/S/P15 min0.1–15 ng/mLAdult male: 1.5–10 ng/mLAdult female: 0.1–0.6 ng/mLCE
IGF-110 µL75 µLWB/S/P15 min20.0–1600.0 ng/mLRefer to user manual
IGFBP-310 µL75 µLWB/S/P15 min0.30–16.00 µg/mLRefer to user manual
E275 µL75 µLWB/S/P15 min20–3000 pg/mLRefer to user manualCE
PRL75 µL75 µLWB/S/P15 min1–200 ng/mLRefer to user manualCE
25-OH-D10 µL100 µLWB/S/P15 min5–70 ng/mL≥30 ng/mLCE
Ferr10 µL100 µLWB/S/P15 min5–500 ng/mLMale: 30–400 ng/mLFemale: 15–150 ng/mLCE
FA10 µL100 µLWB/S/P15 min1.5–20 ng/mL4.9–19.1 ng/mLCE
VB12100 µL100 µLWB/S/P15 min150–1500 pg/mL240–800 pg/mLCE
HB+TF6 fresh fecal positions2–3 dropsFecal15 minHB: 50–1200 ng/mLTF: 20–1200 ng/mLHB: <100 ng/mLTF: <40 ng/mL (8 µg/g feces)CE
tIgE10 µL75 µLWB/S/P10 min2–1000 IU/mLRefer to user manual

83 assays. Where the source table leaves certification blank, this page leaves it blank.

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