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WWHS SARS Cov-19 Antibody Rapid Test Kit Clinical Diagnosis Nucleic
Acid Extraction Kit
【Product name】
SARS-CoV-2 IgM / IgG Antibody Rapid Test Kit(Fluorescence immunoassay)
【Package specification】
25 Tests/kit
【Intended use】
This kit is used for the qualitative detection of SARS-CoV-2 IgM and IgG antibodies in human serum, plasma, and
whole blood samples in vitro. It is only used as a supplementary
detection indicator for suspected cases of negative SARS-CoV-2
nucleic acid detection or for SARS-CoV-2 nucleic acid detection in
suspected case diagnosis. The combined use of the tests cannot be
used as a basis for the diagnosis and exclusion of pneumonitis
caused by SARS-CoV-2 infection, and it is not suitable for
screening in the general population.
【Inspection principle】
This kit is used to detect SARS-CoV-2 IgM and IgG antibodies in
human serum, plasma or whole blood, based on the principle of
fluorescent immunochromatography. If the sample tested contains
SARS-CoV-2 IgM or IgG antibody, the antibodies will bind to the
antigens conjugated fluorescent nanoparticles, and then captured by
the secondary antibodies in detection zone 1 (T1) or detection zone
2 (T2) to form one or two red Lines which can be recognized by a
fluorescent reader, indicating positive results. The quantitative
detection results were obtained by NIR-1000 dry fluoroimmunoassay
analyser.
【Components】
Name | Quantity | Component |
Test cards | 25 | The test card consists of SARS-CoV-2 IgM / IgG antibody test strip and plastic card case; the test strip consists of nitrocellulose membrane, sample pad, fluorescent nanoparticle pad, absorbent paper, and PVC board |
Sample diluent | 1(3mL) | Phosphate buffer |
lancet | 25 | / |
Sampling tube | 25 | / |
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.
【Applicable instruments】
Nir-1000 dry fluorescent immunoassay analyzer produced by WWHS
Biotech. Inc.
【Sample requirements】
1. Serum, plasma, and whole blood samples can be used for testing.
2. Serum / plasma sample collection: Serum and plasma should be
separated as soon as possible after blood collection to avoid
hemolysis. The separated serum and plasma should be tested quickly.
If they cannot be used in a timely manner, they should be stored at
2- 8℃. After 3 days, they should be stored frozen at -20℃. Please
make the sample recover to room temperature before testing. It is
not recommended to use severe hemolytic and heat extinguishing
samples.
3. Whole blood collection: use an anticoagulation tube to collect
blood, or add an anticoagulant in the blood collection tube
(heparin, EDTA salt, sodium citrate lamp anticoagulant are
recommended), add the collected blood sample and shake it for later
use. If it cannot be tested immediately, it can be stored at 2-8℃
for 7 days. Intravenous samples over 7 days are not suitable for
this kt.
【Test procedure】
1.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.)
2.Transfer 20 μL of whole blood or 10 μL of serum or plasma specimen to the sample well, followed by adding 4 drops (100 μL)of sample diluent to the sample well.
3.Insert the test card into NIR-1000 dry fluoroimmunoassay analyser, read and record the results at 15 minutes after addition of samples, then dispose of used test appropriately.
【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 SARS-CoV-2 Nucleocapsid proteins concentration lower than1ng/ml and higher than 500ng/ml, the detection results are reported as "< 1ng/ml" and "> 500ng /ml", respectively.
【Note】
Home Test Kit
Advantage
1. Advanced Quality: We have strict quality control system and
enjoy good reputation in the market.
2. Sincerly Service: We treat clients as friend and aims at
building long term business relatiionship.
FAQ:
1. What is the MOQ?
Generally if you choose the different products, our minimum order
qty. also will be different. One sample available.
2. What about the delivery time?
The goods need 7-21 work days to be made upon deposit.
3. Does your product have any warranty?
Yes, we offer 6 months limited warranty for our products.
Damage due to misuse, ill treatment and unauthorized modifications
and repairs are not covered by our warranty.
4. What's your payment method?
We usually accept the payment methods include PayPal, TT, and
Western Union.
50% deposit in advance and balance before shipping. Buyer can
choose which payment ways that you accept.
PayPal is most useful and safe, please don’t refuse PayPal fee when
you choose PayPal.
5. What's your shipping method?
We provide comprehensive shipping methods.
For small quantity orders we ship by DHL Air-Express, or
EMS/TNT/UPS/FEDEX Express service, it is safe and fast.
For large quantity orders we ship by Air transportation or sea
transportation, we can also ship order to buyer’s cargo agent in
China.