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PCR Rapid Used For Quantitative Determinatione Of D-Dimer ISO Approved

PCR Rapid Used For Quantitative Determinatione Of D-Dimer ISO Approved

Quantitative D-Dimer Rapid Test Kit

ISO D-Dimer Rapid Test Kit

Cassette D-Dimer Test Kit

Place of Origin:

CN

Brand Name:

WWHS

Certification:

ISO 13485, CE

Model Number:

D-Dimer

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Product Details
Product Name:
D-Dimer Rapid Test Kit
Storage:
Room Temperature
Sample Buffer:
25 Vials
Manufacturer:
WWHS BIOTECH INC
Type:
One Step Assay
Reactivity:
Human
Format:
Cassette
Application In:
WWHS NIR-1000 Dry Fluoroimmunoassay Analyser
Keywords:
High Stability, High Sensitivity, High Accuracy
Annual Capacity:
5 Million A Year
Payment & Shipping Terms
Minimum Order Quantity
1000
Price
Negotiable
Packaging Details
Colorful Paper Box
Delivery Time
7 Days
Payment Terms
L/C, T/T
Supply Ability
20000 Kits per Week
Product Description

【Product name】D-Dimer.pdf

D-Dimer Rapid Quantitative Test(Fluorescence immunoassay)

 

【Package specification】

20 Tests/box

 

【Intended use】

This kit is used for quantitative determination of D-dimer in human whole blood and plasma.

 

 

【Storage conditions and validity】

The test card should be stored at 4℃~30℃, dry, dark and no freezing. It should be stored in sealed aluminum foil bag and valid for 12 months. The test card should be returned to room temperature (15℃~30℃) before opening. It 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 instruments】

NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc.

 

 

【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 fluoroimmunoassay analyser 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. Mix 10 µL of patient sample with 300µL of sample diluent. Apply 100 µL of diluted samples to the well of the test card.
  6. Insert the test card into NIR-1000 dry fluoroimmunoassay analyser, press the [timing detection] key, automatically time for 10 minutes, automatically judge the test results, and display the quantitative results on the screen. Or insert the test card into the analyzer after timing for 10 minutes, and press the [real time detection] key, and the instrument will automatically interpret the test results.

【Reference interval】

By measuring 268 healthy people aged between 19 and 79, statistical analysis shows that the reference interval is less than 500 ng/ml. According to the characteristics of the local population, the reference intervals of the laboratories were established.

【Interpretation of results】

  1. This reagent is only used for auxiliary detection. If the test results are abnormal, it should be reviewed in time and judged in combination with clinical symptoms.
  2. For samples with D-dimer concentration lower than 40ng/ml and higher than 10000ng/ml, the detection results are reported as "< 40ng/ml" and "> 10000ng /ml", respectively.

 

1. Analysis sensitivity

No more than 40ng/ml.

2. Accuracy

The relative deviation from the target value is within ±15%.

3. Precision

The within and between assay coefficient of variations are within 15%.

4. Linear range

Within the linear range (40 ~ 10000ng/ml), the linear correlation coefficient R≥0.990.

 

PCR Rapid Used For Quantitative Determinatione Of D-Dimer ISO Approved 0PCR Rapid Used For Quantitative Determinatione Of D-Dimer ISO Approved 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

 

 

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