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HBA1C Home Test Kit Rapid Cassette Test FIA POCT Assay Use For Diagnosis Of Diabetes

HBA1C Home Test Kit Rapid Cassette Test FIA POCT Assay Use For Diagnosis Of Diabetes

HBA1C Home Test Kit Rapid Cassette Test FIA POCT Assay Use For Diagnosis Of Diabetes
HBA1C Home Test Kit Rapid Cassette Test FIA POCT Assay Use For Diagnosis Of Diabetes
HBA1C Home Test Kit Rapid Cassette Test FIA POCT Assay Use For Diagnosis Of Diabetes
Product Details:
Place of Origin: CN
Brand Name: WWHS
Certification: ISO13485
Model Number: HbA1c
Payment & Shipping Terms:
Minimum Order Quantity: 2000
Price: US 1.50-2.50 Kit
Packaging Details: Colorful Paper Box
Delivery Time: 10 Days
Payment Terms: L/C, T/T
Supply Ability: 20000 Kits per Week
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Detailed Product Description
Product Name: HbA1c Rapid Quantitative Test Kit Sample Buffer: 25 Vials
Warranty: 12 Months Applicable Instruments: NIR-1000 Dry Fluorescent Immunoassay Analyzer
Throughput: 3000 Tests/Day Advantage: High Sensitivity
Manufacturer: WWHS Biotech INC Storage: 4-30℃
Supply Ability: 10 Million A Year Format: Cassette
High Light:

CE HbA1c Rapid Quantitative Test Kit

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ISO13485 HBA1C Rapid Test Kit

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HBA1C Rapid Test Kit High Sensitivity

【Product Name】 HbA1c.pdf

Haemoglobin A1c(HbA1c)Rapid Quantitative Test (Fluorescence immunoassay)

 

【Packing Specification】

25 Tests/kit

 

【Intended Use】

The kit is used for quantitative determination of HbA1c in human whole blood,and is mainly used for diagnosis of diabetes and monitoring of blood glucose level clinically.

 

【Test principle】

This kit is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of HbA1c. The HbA1c antigen in the sample was first bound with the conjugated compound of fluorescent labeled HbA1c monoclonal antibody, then moved and combined with Hb monoclonal antibody fixed on the nitrocellulose membrane, and the double antibody sandwich complex was formed at the detection line of the cellulose nitrate membrane. The quantitative detection results were obtained by NIR-1000 dry fluorescence immunoassay.

 

【Applicable Instrument】

NIR-1000 dry fluorescent immunoassay analyzer produced by WWHS Biotech. Inc.

 

 

【Test procedure】

  1. Before the test, please read the instructions completely. If the test card and sample are stored in cold storage, they should be balanced at room temperature (15-30)℃ for not less than 30min before use.
  2. Start NIR-1000 dry fluorescence immunoassay analyzer according to the instruction manual of the instrument, and carry out quality control verification according to the instruction manual of the instrument(Note: the reagent has been calibrated in advance, and the calibration curve parameters of each batch of reagent have been stored in the information card. The information card is inserted before use, so it is not necessary to calibrate again, and the test can be carried out only after the quality control is passed. Otherwise, the cause should be found out before testing.)
  3. Remove the test card from the aluminum foil bag and use it within 15 minutes.
  4. Place the test card on a clean horizontal table and mark it horizontally.
  5. Add 10μL of sample into HbA1c sample diluent (1.00mL). After mixing thoroughly the solution for 1 min, take 100μL of the solution and add it into the well.
  6. Insert the test card into NIR-1000 dry fluoroimmunoassay analyser, read and record the results at 10 minutes after addition of samples, then dispose of used test appropriately.

 

 

 

 

Other WWHS POCT Assay Items

 

cat#. Product item Specimen Reaction Time Measure Range Clinical Range Itended Use
1 cTnI WB/Serum/Plasma 12min. 0.1-40ng/ml <0.3ng/ml several heart diseases including myocardial infarction and heart failure.
2 Myo WB/Serum/Plasma 12min. 5-400ng/ml <58ng/ml acute myocardial infarction (AMI) in early stage.
3 CK-MB WB/Serum/Plasma 12min. 1-200ng/ml <5ng/ml acute myocardial infarction (AMI) in early stage.
4 NT-proBNP WB/Serum/Plasma 10min. 20-35000pg/ml Under 75:0~347pg/mL,
Over 75:0~449pg/mL		 heart failure .
5 D-Dimer WB/Plasma 10min. 40-10000ng/ml <500ng/ml disseminated intravascular coagulation (DIC),deep vein thrombosis (DVT),pulmonary embolism (PE), myocardial infarction, cerebral infarction, etc.
6 cTnI+Myo+CKMB WB/Serum/Plasma 12min. same with single item same with single item Triple marker of myocardial infarction.
7 ST2 WB/Serum/Plasma 10min. 10-400ng/ml <35ng/ml heart failure .
8 Lp-PLA2 WB/Serum/Plasma 10min. 10-900ng/ml <175ng/ml Risk evaluation of ACS and atherosclerotic ischemic stroke patients.
9 S100-β WB/Serum/Plasma 10min. 0.05-10ng/ml <0.2ng/ml Cerebral infarction, cerebral injury.
Inflammation 　 　 　 　 　
10 CRP / hs-CRP WB/Serum/Plasma 3min. 0.5-200mg/L CRP<10mg/L,hs-CRP<1mg/L nonspecficity inflammatory marker.
11 SAA Serum 5min. 1-200mg/L <10mg/L inflammation&infection.
12 PCT WB/Serum/Plasma 10min. 0.2-100ng/ml <0.5ng/ml Sepsis
13 CRP+SAA WB/Serum/Plasma 5min. same with single item same with single item inflammation&infection.
14 IL-6 WB/Serum/Plasma 10min. 5-4000pg/ml 10pg/ml diabetes,rheumatoid arthritis,etc
Thyroid Hormone 　 　 　 　 　
15 TSH Serum/Plasma 15min. 0.3-100mU/L 0.35-5mU/L hyperthyroidism and hypothyroidism
16 TT3 Serum/Plasma 15min. 0.5-10nmol/L 1.3-3.1nmol/L thyroid dysfunction
17 TT4 Serum/Plasma 15min. 5-300nmol/L 66-181nmol/L thyroid dysfunction
18 FT3 Serum/Plasma 15min. 1-100pmol/L 4-10pmol/L thyroid dysfunction
19 FT4 Serum/Plasma 15min. 5-300pmol/L 19-39pmol/L thyroid dysfunction
Tumor Marker 　 　 　 　 　
20 AFP Serum/Plasma 15min. 2.5-200ng/ml <20ng/ml pregnancy cancer
21 CEA Serum/Plasma 15min. 1-200ng/ml <5ng/ml colon cancer, colorectal cancer,etc.
22 NSE Serum/Plasma 15min. 1-400ng/ml <16ng/ml non-small cell lung cancer
23 FOB fecal specimens 10min. 50-1000ng/ml <100ng/ml Abnormal recessive gastrointestinal bleeding
24 PG II Serum/Plasma 15min. 1-100ug/L PGI/PGII>3.0 gastric abnormalities
25 PG I Serum/Plasma 15min. 2.5-200ug/L >70ng/ml gastric abnormalities
26 TPSA Serum/Plasma 15min. 0.5-40ng/ml <4ng/ml prostate cancer
27 FPSA Serum/Plasma 15min. 0.1-10ng/ml <1ng/ml prostate cancer
28 CA12-5 Serum/Plasma 15min. 20-500U/ml <35U/ml ovarian cancer
29 CA15-3 Serum/Plasma 15min. 10-400U/ml < 25 U/mL breast cancer
30 HE4 Serum/Plasma 15min. 50-2000pmol/L <140 pmol/L ovarian cancer
31 CA19-9 Serum/Plasma 15min. 10-400U/ml < 27 U/mL pancreatic cancer
32 β-HCG Serum/Plasma 15min. 5-400mIU/ml <10 mIU/mL Early pregrancy, ectopic HCG cancer,incomplete abortion
33 CK19(Cyfra21-1) Serum/Plasma 15min. 0.5-50ng/ml <2.5ng/ml non-small cell lung cancer
Fertility 　 　 　 　 　
34 HCG / β-HCG Serum/Plasma 10min. 5-20000mIU/ml <5 mIU/mL early pregrancy.
35 AMH Serum/Plasma 10min. 0.1-16ng/ml Male: 20-60 years old, 0.92-13.89 ng/mL
Female: 20-29 years old, 0.88-10.35 ng/mL
30-39 years old, 0.31-7.86 ng/mL 40 -50 years old, <5. 07 ng/mL		 ovarian reserve level
36 LH Serum/Plasma 20min. 1-200mIU/ml Male: 1.70-8.60 mIU/mL;
Female:
Follicular phase : 2.95 13.65 mIU/mL
Ovulation phase: 13.65-95.75 Miu/mL Luteal phase: 1.25-11.00 mIU/mL
Menopause phase: 8.24 -55.23 mIU/mL		 reproductive dysfunction
37 FSH Serum/Plasma 20min. 1-100mIU/ml Male: 1.50-12.40 mIU/mL
Female:
Follicular phase : 4.46-12.43 mIU/mL Ovulation phase: 4.88-20.96 mIU/mL Luteal phase: 1 .96-7.70 mIU/mL
Menopause phase: 22.70-130.00 mIU/mL		 reproductive system
38 Testosterone Serum/Plasma 20min. 0.25-16ng/ml Male: 20-49 years old, 1.61-8.41 ng/mL
>50 years old, <0.61 ng/mL
Female: 20-49 years old, <0.80ng/mL
>50 years old, <0.71 ng/mL		 sexual hormone disturbance and hypogonadism.
39 Progesterone Serum/Plasma 20min. 1-50ng/ml 　 pregrancy progesterone
40 PRL Serum/Plasma 20min. 1-200ng/ml Female (non-pregnant): 4.60-25.07 ng/mL Male: 3.45-17.42 ng/mL breastfeeding&abnormal lactation
41 SHBG Serum/Plasma 20min. 1-200nmol/L 15-120nmol/L unphysiological diseases.
42 E2 Serum/Plasma 20min. 10-1000pg/ml Male: <85 pg/mL
Female:
Follicular Phase: 12-262 pg/mL
Ovulation: 40-396 pg/mL
Luteal Phase: 21-381 pg/mL
Menopause: <190 pg/mL
Pregnancy: >145 pg/mL		 ovarian vitality.
Gastrointestinal 　 　 　 　 　 　
43 FOB fecal specimens 10min. qualitative qualitative gastrointestinal hemorrhage.
44 TRF fecal specimens 10min. qualitative qualitative gastrointestinal hemorrhage.
45 FOB+TRF fecal specimens 10min. qualitative qualitative gastrointestinal hemorrhage.
Infection 　 　 　 　 　 　
46 Covid-19 Antigen nasal swab, throat swab or nasal wash/aspirate specimens 15min. qualitative qualitative respiratory tract
47 Covid-19 Ab IgG/IgM WB/Serum/Plasma 15min. qualitative qualitative respiratory tract
48 FluA nasal swab, throat swab or nasal wash/aspirate specimens 15min. qualitative qualitative respiratory tract
49 FluB nasal swab, throat swab or nasal wash/aspirate specimens 15min. qualitative qualitative respiratory tract
Renal injury 　 　 　 　 　 　
50 CysC WB/Serum/Plasma 5min. 0.4-9mg/L 0.5-1.1mg/L renal function
51 NGAL Urine 10min. 10-1500ng/mL <132ng/mL acute kidney injury.
Other 　 　 　 　 　 　
52 FERR Serum 5min. 10-500ng/ml Male:24ng/mL~335ng/mL,
Female:11ng/mL~307ng/mL		 iron metabolism related diseases, such as hemochromatosis and iron deficiency anemia

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HbA1c Rapid Test Diagnostic Kit,

FIA POCT Assay,

POCT HBA1C Home Test Kit

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Tel: +8613823276027

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Address: Rm 505, 1st Building, Shenzhen Biomedicine Innovation Industrial Park, No. 14th, Jinhui Road, East Jinxiu Road, Kengzi Street, Pingshan District, Shenzhen

Factory Address:Rm 505, 1st Building, Shenzhen Biomedicine Innovation Industrial Park, No. 14th, Jinhui Road, East Jinxiu Road, Kengzi Street, Pingshan District, Shenzhen

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