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T3 POCT Test Kit / FIA Rapid Quantitative Test Kit 20T IVD Assay

T3 POCT Test Kit / FIA Rapid Quantitative Test Kit 20T IVD Assay

T3 POCT Test Kit

20T POCT Test Kit

IVD Assay T3 Test Kit

Place of Origin:

CN

Brand Name:

WWHS

Certification:

ISO 13485, CE

Model Number:

T3

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Product Details
Product Name:
T3 Rapid Quantitative Test Kit
Storage:
Room Temperature
Sample Buffer:
25 Vials
Manufacturer:
WWHS BIOTECH INC
Type:
One Step Assay
Application:
Human
Pack Size:
25 Tests
Supply Ability:
5 Million A Year
Feature:
High Sensitivity
Format:
Cassette
Payment & Shipping Terms
Minimum Order Quantity
1000
Price
US 1.50-2.99 Kit
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】

Total Triiodothyronine(TT3)Rapid Quantitative Test(Fluorescence immunoassay)

 

【Package specification】

25 Tests/kit

 

【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.

 

【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.

 

【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 fluoroimmunoassay analyser and correctly select the corresponding sample type on the instrument.
  3. 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.
  4. Take out the test card from the aluminum foil bag and use it within 15 minutes.
  5. Place the test card on a clean horizontal table and mark it horizontally.
  6. Mix 100 µL of patient sample with 200µL of sample diluent. Apply 100 µL of diluted samples to the well of the test card.
  7. 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.

【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.

 

【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.

 

 

T3 POCT Test Kit / FIA Rapid Quantitative Test Kit 20T IVD Assay 0

 

WWHS Assay list  Thyroid Hormone        
cat#. Product Item Specimen Reaction Time Measure Range Clinical Range Intended Use
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

 

 

 

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 cTnI concentration is lower than 0.1ng/mL and higher than 40ng/mL, test result is “<0.1ng/mL” and “>40ng/mL” respectively.

 

About NIR-1000 Dry Fluoroimmunoassay Analyser

 

It is a fluorescence immunochromatographic analysing system with internal temperature control,
which can help diagnose conditions such as infection, diabetes, cardiovascular diseases, renal injury and cancers, etc.
Immunofluorescence technology
Testing time less than 15 minutes
Easy-to-use touch-screen platform,multi-language system

 

Wide-Range Diagnostics, It can be used in following areas:

1) Department of thoracic Surgery

2) Clinical Laboratory

3) Department of Emergency

4) First Aid Community Hospital

5) Department of Respiration

6) CCU/ICU

7) Department of cardiology

8) Department of Geriatrics

 

FAQ


1. What is fluorescent immunoassay analyzer?
The Biopanda Fluorescence Immunoassay Analyser is used by small labs for the detection of a range of biomarkers to assist with the diagnosis and monitoring of several medical conditions including cardiovascular disease, inflammation, kidney disease, thyroid conditions, and fertility.


2. Do you have CE certificate for immunoassay analyzer?

WBC analyzer belongs to IVD other/general, no need CE, Ec declaration is enough.


3. How does fluorescence immunoassay work?
Fluorescent Immunoassays are simply a different type of immunoassay. ... A modern fluorescent based immunoassay uses as the detection reagent a fluorescent compound which absorbs light or energy (excitation energy) at a specific wavelength and then emits light or energy at a different wavelength.

 

4. What is indirect immunofluorescence assay?
Indirect immunofluorescence, or secondary immunofluorescence, is a technique used in laboratories to detect circulating
autoantibodies in patient serum. It is used to diagnose autoimmune blistering diseases.

 

5. Is immunofluorescence an immunoassay?
Immunofluorescence assay (IFA) is a standard virologic technique to identify the presence of antibodies by their specific ability to react with viral antigens expressed in infected cells; bound antibodies are visualized by incubation with fluorescently labeled antihuman antibody.

 

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