WWHS FIA TT4 Rapid Quantitative Test Kit Application In
Fluorescence Immunoassay NIR-1000 Analyser
TT4.pdf
Inspection principle
The T4 Rapid Test is a one-step chromatographic sandwich
immunoassay designed for the quantitative measurement of T4. The T4
antigen in the sample was first bound with the conjugated compound
of fluorescent labeled T4 monoclonal antibody, then moved and
combined with another T4 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-type fluorescence immunoassay.
Testing
【Product name】
Total Thyroxine(TT4)Rapid Quantitative Test(Fluorescence
immunoassay)
【Package specification】
25 Tests/kit
【Performance】
1. Limits of detection
No higher than 5.0nmoL/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 (5.0 ~300.0 nmoL/L), the linear correlation
coefficient R≥0.990.
【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.
【Components】
| Name | Quantity | Component |
| Test cards | 25 | It is composed of fluorescent pad (coated with fluorescent labeled
T4 monoclonal mouse antibody), nitrocellulose membrane (coated with
T4 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.
【Applicable instruments】
NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech.
Inc.
【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
| Thyroid Hormone | | | | | |
| cat#. | Product item | Specimen | Reaction Time | Measure Range | Clinical Range | Itended 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 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 AFP concentration lower than 2.5ng/ml and
higher than 200ng/ml, the detection results are reported as "<
2.5ng/ml" and "> 200ng /ml", respectively.
Limitations of methods
1. This kit is only used to detect human plasma/whole blood samples
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
15mg/ml, the content of hemoglobin shall not exceed 5mg/ml, and the
content of bilirubin shall not exceed 0.5mg/ml, and the relative
deviation of the test results shall not exceed ±15%.
4. When the concentration of AFP in the sample is less than
20000ng/ml, there is no hook effect.
5. HAMA effect was not produced when the concentration of human
anti rat in the sample was less than 50ng/ml.
6. When RF concentration in the sample is less than 2000IU/ml, the
relative deviation of the test results is within ±15%.
Applicable Instrument
WWHS NIR-1000 dry fluoroimmunoassay analyser
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.
