【Product name】
Total Triiodothyronine(TT3)Rapid Quantitative Test(Fluorescence
immunoassay)
【Package specification】
25 Tests/kit
【Performance】
1. Limits of detection,No more than 0.50 nmoL/L.
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 (0.50 ~ 10.00nmoL/L), the
linear correlation coefficient R≥0.990.
【Components】
| Name | Quantity | Component |
| Test cards | 25 | It is composed of fluorescent pad (coated with fluorescent labeled
T3 monoclonal mouse antibody), nitrocellulose membrane (coated with
T3 monoclonal mouse antibody and Goat anti mouse IgG antibody),
absorbent paper and backing |
| Sample diluent | 25(200μL/tube) | Phosphate buffer |
| ID card | 1 | With specific stand curve file |
The components in different batches of kits cannot be used
interchangeably.
【Test procedure】
- 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.
- Start NIR-1000 dry fluoroimmunoassay analyser and correctly select
the corresponding sample type on the instrument.
- Take out the ID card, make sure that the batch number of the ID
card is consistent with that of the test card, and insert the ID
card into the ID card port of the instrument.
- Take out the test card from the aluminum foil bag and use it within
15 minutes.
- Place the test card on a clean horizontal table and mark it
horizontally.
- Mix 100 µL of patient sample with 200µL of sample diluent. Apply
100 µL of diluted samples to the well of the test card.
- At 15 minutes after addition of samples, insert the test card into
NIR-1000 dry fluoroimmunoassay analyser and click the “Instant
test” button to read the results.
【Note】
1. This kit is only used for in vitro diagnosis.
2. The test card and sample diluent are disposable and 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. The requirements of specimen collection and storage should be
strictly observed. If the specimen is turbid, it should be
centrifuged and discarded before use.
5. The used kits should be treated as potential infectious
substances, and all samples, reagents and potential pollutants
should be disinfected and treated according to the relevant local
regulations.
WWHS POCT 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 | T3 | Serum/Plasma | 15min. | 0.5-10nmol/L | 1.3-3.1nmol/L | thyroid dysfunction |
| 17 | T4 | Serum/Plasma | 15min. | 5-300nmol/L | 66-181nmol/L | thyroid dysfunction |
| Tumor Marker | | | | | |
| 18 | AFP | Serum/Plasma | 15min. | 2.5-200ng/ml | <20ng/ml | pregnancy cancer |
| 19 | CEA | Serum/Plasma | 15min. | 1-200ng/ml | <5ng/ml | colon cancer, colorectal cancer,etc. |
| 20 | NSE | Serum/Plasma | 15min. | 1-400ng/ml | <16ng/ml | non-small cell lung cancer |
| 21 | FOB | fecal specimens | 10min. | 50-1000ng/ml | <100ng/ml | Abnormal recessive gastrointestinal bleeding |
| 22 | PG II | Serum/Plasma | 15min. | 1-100ug/L | PGI/PGII>3.0 | gastric abnormalities |
| 23 | PG I | Serum/Plasma | 15min. | 2.5-200ug/L | >70ng/ml | gastric abnormalities |
| 24 | PSA | Serum/Plasma | 15min. | 0.5-40ng/ml | <4ng/ml | prostate cancer |
| 25 | FPSA | Serum/Plasma | 15min. | 0.1-10ng/ml | <1ng/ml | prostate cancer |
| 26 | CA12-5 | Serum/Plasma | 15min. | 20-500U/ml | <35U/ml | ovarian cancer |
| 27 | CA15-3 | Serum/Plasma | 15min. | 10-400U/ml | < 25 U/mL | breast cancer |
| 28 | HE4 | Serum/Plasma | 15min. | 50-2000pmol/L | <140 pmol/L | ovarian cancer |
| 29 | CA19-9 | Serum/Plasma | 15min. | 10-400U/ml | < 27 U/mL | pancreatic cancer |
| 30 | β-HCG | Serum/Plasma | 15min. | 5-400mIU/ml | <10 mIU/mL | Early pregrancy, ectopic HCG cancer,incomplete abortion |
| 31 | CK19(Cyfra21-1) | Serum/Plasma | 15min. | 0.5-50ng/ml | <2.5ng/ml | non-small cell lung cancer |
Packing and Delivery
Packing: Standard packing, neutral packing, OEM packaging are
welcome;
Delivery: According to the specific quantity of the product;
Payment: Credit Card, Paypal, Local Bank, Western Union, T/T, etc.
Shipping: International Express, by Air, by Sea, etc;
