Place of Origin:
CN
Brand Name:
WWHS
Certification:
ISO 13485, CE
Model Number:
D-Dimer
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【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】
【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. 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.
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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