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Hemoglobin Level HBA1C Rapid Test Kit Fluorescence Immunoassay 25T Package

Hemoglobin Level HBA1C Rapid Test Kit Fluorescence Immunoassay 25T Package

  • Hemoglobin Level HBA1C Rapid Test Kit Fluorescence Immunoassay 25T Package
  • Hemoglobin Level HBA1C Rapid Test Kit Fluorescence Immunoassay 25T Package
  • Hemoglobin Level HBA1C Rapid Test Kit Fluorescence Immunoassay 25T Package
  • Hemoglobin Level HBA1C Rapid Test Kit Fluorescence Immunoassay 25T Package
  • Hemoglobin Level HBA1C Rapid Test Kit Fluorescence Immunoassay 25T Package
Hemoglobin Level HBA1C Rapid Test Kit Fluorescence Immunoassay 25T Package
Product Details:
Place of Origin: CN
Brand Name: WWHS
Certification: CE
Model Number: HbA1c
Payment & Shipping Terms:
Minimum Order Quantity: 1000
Price: US 1.50 - 2.50 Kit
Packaging Details: Paper Box
Delivery Time: 7 Days
Supply Ability: 50000 Kits per Week
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Detailed Product Description
Product Name: HbA1c Rapid Quantitative Test Kit Advantage: High Accuracy
Package: 25T Manufacturer: WWHS Biotech INC
Supply Ability: 10 Million A Year Shelf Life And Storage Temperature: 12 Months At 4-30°C
After-sale Service: Online Technical Support Generic Name: Diagnostic Kit For Haemoglobin A1c (Immunochromatographic Assay)
Format: Cassette Accurate: High Sensitivity And Specifity
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Hemoglobin HBA1C Rapid Test Kit

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WWHS HBA1C Rapid Test Kit

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20T Hemoglobin Level Test Kit

【Product Name】

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.

 

【Components】

Name Quantity Component
Test cards 25 The product consists of fluorescent mat (coated with fluorescently-labeled HbA1c mouse antibody), nitrocellulose membrane (coated with HbA1c mouse antibody and Goat anti mouse IgG antibody), absorbent paper and PVC soleplate, and so on.
Sample diluent 25 (1.0mL/ tube) Phosphate buffer
ID card 1 With specific stand curve file

The components in different batches of kits cannot be used interchangeably.

 

【Storage Conditions and Validity】

The kit should be stored at 4℃~30℃, out of direct sunlight. It is valid for 18 months. The test card should be used within 15 minutes after unsealing under the environment of 15℃~30℃ and 20% ~ 90% relative humidity.

The production date, batch number and expiration date are shown in the outer package of the product.

 

【Applicable Instrument】

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

 

【Sample Requirements】

  1. The whole blood should be collected in a tube containing EDTA as the anticoagulant.
  2. Venous blood was collected according to routine laboratory methods to avoid hemolysis.
  3. It is highly recommended to use fresh samples instead of keeping the samples at room temperature for a long time. After samples were collected, the detection should be completed within 4 hours at room temperature (15℃~30℃). The whole blood sample can be stored at 2℃~8℃ for 48 hours.
  4. Before testing, the sample should return to room temperature (15℃~30℃). The frozen samples should be completely thawed, rewarming and mixed evenly before use. Repeated freeze-thaw cycles should be avoided.

 

【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.

 

【Reference Interval】

Test and analyze the HbA1c in the whole blood from 269 healthy people aged 17-89, according to 95th percentile method, the result shows that HbA1c reference interval is 4.0%-6.0%. It is strongly recommended that each laboratory should determine its own normal and abnormal values.

 

【Interpretation of Test Results】

  1. The kit can be used for auxiliary test only. If test result is abnormal, retest timely and judge combined with clinical symptoms.
  2. For samples whose HbA1c concentration is lower than 4.0% and higher than 14.0%, test result is “<4.0%” and “>14.0%” respectively.

 

【Limitation of Test Method】

1. The kit is only used to test whole blood specimens of human body.

2. Due to the limitations of immunoassay methods of antigen and antibody reaction, the results cannot be used as the only basis for clinical diagnosis, but should be evaluated with all the existing clinical and experimental data.

3. The content of triglyceride in the sample shall not exceed 10mg/ml, the content of bilirubin shall not exceed 0.2mg/ml, the content of glucose shall not exceed 10mg/ml, and the relative deviation is limited to ±10.0%.

4. When HbA1c concentration of samples reaches 18.0%, there is no hook effect.

  1. HAMA effect was not produced when the concentration of human anti rat in the sample was less than 50ng/ml.

6. When RF concentration of samples is less than 2000IU/mL, relative deviation of test result is limited to ±10.0%.

7. For samples exceeding the linearity range, test cannot be conducted after dilution.

 

【Performance 】

1. Limits of detection

No higher than 4.0%.

2. Accuracy

The relative deviation to the target value is limited to ±10.0%.

3. Repeatability

Coefficient of variations are within 10%.

4. Batch-to-batch difference

The relative range (R) between batches shall not be greater than 15.0%.

5. Linearity range

Within the specified linearity range (4.0%-14.0%):

a) Linearly dependent coefficient (r) is no less than 0.9900;

b) Within (4.0%-6.0%), linear absolute deviation is limited to ±0.6%.

Within (6.0%-14.0%), linear absolute deviation is limited to ±10.0%.

 

【Note】

1. The kit can be used for in vitro diagnosis only.

2. Test card and buffer solution are single-use and they cannot be reused.

3. Please check the integrity and validity of the kit package before use, and then open the package. When it is stored at low temperature, it should be restored to room temperature (15℃ ~ 30℃) before opening the package for use. The reagents with damaged inner package and beyond the validity period cannot be used.

4. Take the test card out of the aluminum foil bag and carry out experiment in 15min. Do not place it in the air for a long time to avoid dampness.

5. It is required to strictly comply with the requirements for sample collection and storage. If the sample is turbid, please centrifuge and precipitate it before use.

6. The kit used should be disposed of as latent infective material, and all samples, reagents and latent contaminants should be disinfected and disposed of according to relevant local regulations.

 

Hemoglobin Level HBA1C Rapid Test Kit Fluorescence Immunoassay 25T Package 0Hemoglobin Level HBA1C Rapid Test Kit Fluorescence Immunoassay 25T Package 1

 

WWHS Assay list          
Cardiac          
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
Gastrointestinal            
36 FOB fecal specimens 10min. qualitative qualitative gastrointestinal hemorrhage.
37 TRF fecal specimens 10min. qualitative qualitative gastrointestinal hemorrhage.
38 FOB+TRF fecal specimens 10min. qualitative qualitative gastrointestinal hemorrhage.
Infection            
39 C.Pneumonia WB/Serum/Plasma 15min. qualitative qualitative CP infection
40 M.Pneumonia WB/Serum/Plasma 15min. qualitative qualitative MP infection
41 Covid-19 Antigen nasal swab, throat swab or nasal wash/aspirate specimens 15min. qualitative qualitative respiratory tract
42 Covid-19 Ab IgG/IgM WB/Serum/Plasma 15min. qualitative qualitative respiratory tract
43 FluA nasal swab, throat swab or nasal wash/aspirate specimens 15min. qualitative qualitative respiratory tract
44 FluB nasal swab, throat swab or nasal wash/aspirate specimens 15min. qualitative qualitative respiratory tract
Renal Injury            
45 CysC WB/Serum/Plasma 5min. 0.4-9mg/L 0.5-1.1mg/L renal function
46 NGAL Urine 10min. 10-1500ng/mL <132ng/mL acute kidney injury.
Other            
47 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
48 HbA1c WB 10min. 4%-14% 4%-6% diabetes
49 VD Serum/Plasma 15min. 8-70ng/mL 19-57ng/mL fetation

 

Advantage:

 

1. Advanced Quality: We have strict quality control system and enjoy good reputation in the market.

2. Sincerly Service: We treat clients as friend and aims at building long term business relatiionship.

 

FAQ:


Q. How is your company's product after-sales service system?
A. The product warranty period is 12 months, we can provide lifetime maintenance. We have professional pre-sales and after-sales teams that can respond to you within 24 hours to resolve technical issues. We provide one-to-one after-sales service.

 

Q: Can you customize it?
A: Yes, we accept customization according to customer's specific requirements.

 

Q. How long is your lead time? If I want to customize instruments, how long will it take?
A. When order quantity is 1-10 units, we have ready stock goods, we can ship out within 3-5 working days after receipt of deposit; products required new production of common materials, usually the lead time is about 10-15 days; products requiring new production of special and rare materials, usually the lead time is about 20-30 days.

 

Most Of FIA Rapid Test Cassette Assay Such As Cardiac and Inflammation Items Are Available For 5-10 days Prompt Shipment.

 

Q. What payment method do you accept?
A. Our company accept payment method of T/T (bank transfer), Western Union, PayPal and so on.

 

Q. What package do you use for your products? What shipping method do you use?
A.1. Our company use standard exporting carton for packing. 2. We ship via express courier (door to door service), by air, and by sea according to customers' requirements.

 

For more questions, please feel free to send inquiries to us.

 

Contact Details
WWHS Biotech.Inc(exclusive marketed by Dawin)

Contact Person: sales

Tel: +8613823276027

Send your inquiry directly to us (0 / 3000)

Contact

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