• OEM Neutralizing Antibody COVID-19 Test For Professional Testing 99.9 Percent
OEM Neutralizing Antibody COVID-19 Test For Professional Testing 99.9 Percent

OEM Neutralizing Antibody COVID-19 Test For Professional Testing 99.9 Percent

Product Details:

Place of Origin: China
Brand Name: Vchek

Payment & Shipping Terms:

Minimum Order Quantity: negotiable
Price: negotiable
Delivery Time: 10-15days
Payment Terms: T/T, Western Union
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Detail Information

Sample Type:: Saliva Key Words: Saliva Antigen Rapid Test Kit
Storage:: Room Temperature Accuracy:: 99.9%
Using:: Self Test Detection: Nucleocapsid Protein Antigen From 2019 NCoV
High Light:

OEM COVID-19 Test

,

99.9 COVID-19 Test

Product Description

2019nCov Ag Rapid Test Kit

Description

This test kit is a rapid chromatographic immunoassay for semi-quantitative detection of neutralization antibodies to SARS-CoV-2, in human serum or plasma. Neutralization antibodies bind specifically to a pathogen's proteins which are used to interact with and infect host cells, blocking their functional domains; this prevents the pathogen from being infectious, and grants the host 'sterilizing immunity'. This kit detects the presence of human antibodies against the SARS-CoV-2 virus's Receptor Binding Domain (RBD), on the viral spike protein (S), and can therefore be used to test for possible immunity.

 

SARS-CoV-2 Neutralization Antibody Detection Kit is a faster, easier, more scalable and automatable alternative to traditional neutralizing antibody tests, such as virus neutralization test (VNT), pseudo-virus neutralization test (pVNT) and plaque reduction neutralization test (PRNT). The kit has the capability of measuring functional neutralizing antibodies (NAbs) within an hour instead of the days required by the traditional tests. cPass Neutralization Antibody detection kit does not require live biological materials or strict biosafety containment for testing

 

MATERIALS AND COMPONENTS

 

INTENDED USE

This Kit is an in vitro diagnostic test for the qualitative detection of IgG and IgM antibodies to the 2019-nCoV in human serum, plasma, whole blood or finger stick blood.

This product is used as a supplementary detection indicator for suspected cases with negative detection of 2019-nCoV nucleic acid or used in conjunction with nucleic acid detection in the diagnosis of suspected cases.

It cannot be used as a basis for diagnosis and exclusion of 2019-nCoV pneumonia, and is not suitable for general population screening.

A positive test result needs further confirmation. A negative test result cannot rule out the possibility of infection.

This test kit is not for the screening of donated blood.

This test kit is only provided for medical institutions

SUMMARY AND EXPLANATION

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

PRINCIPLE

2019-nCoV IgG&IgM Antibody Rapid Test Kit is based on lateral flow immunochromatographic assay. The cassette including: 1) The recombinant novel coronavirus antigen with colloidal gold-labeled and control antibody gold marker; 2) Nitrocellulose membrane with settled two test lines (G and M) and one control line (C). M line with settled monoclonal anti-human IgM antibody; G line with settled reagent for IgG antibody test; C line with settled control antibody. When the proper specimen is added into the test device, it will be absorbed into the device by capillary action, the antibody will combine with 2019-NCOV antigen which colloidal gold-labeled if with the IgM antibody, the immune complex will be captured by the settled anti-human IgM antibody, a colored line appearing in test line(M) which means positive for IgM antibody; and if with the IgG antibody, it will be captured by the settled reagent, a colored line will appearing in test line(G) which means positive for IgG antibody. If test lines G and M without any appearance means negative result. There is a control region C in the cassette, the colored line will appear at the control line C no matter test line appeared or not. To serve as a procedure control, a colored line will appear at the Control Region(C), if the test had been performed properly

MATERIALS AND COMPONENTS

Materials provided with the test kits

Specifications

 

Ingredients

1 test/Kit

10

tests/Kit

20

tests/Kit

25

tests/Kit

Test Cassette 1 10 20 25

Sample Buffe

5ml/bottle

1 1 1 1
Dripper 1 10 20 25
Instructions for use 1 1 1 1

Note: The components in different batches cannot be used interchangeably.

Materials required but not provided

  • Timer clock
  • Specimen Collection Containers
  • Centrifuge (for serum/plasma sample)
  • Appropriate disinfectants.

STORAGE AND STABILITY

  • Store at 2°C - 30°C in the sealed pouch up to the expiration date printed on the package. Do not freeze.
  • The test cassette is used within 1 hour after taking out from the foil envelope. Buffer solution are re-capped in time after use.
  • Keep away from sunlight, moisture and heat.
  • Kit contents are stable until the expiration date printed on the outer box.
  • The product will be expired after 24 months.

SPECIMEN COLLECTION AND PREPARATION

For whole blood, serum and plasma.

  • Using standard phlebotomy procedure, collect a venipuncture whole blood specimen using a blood collection tube with suitable anticoagulant (containing EDTA, Heparin or Citrated sodium). Other anticoagulants have not been validated and may give incorrect result.
  • It is recommended that the specimen is tested at the time of specimen collection. If the specimens are not tested immediately, they may be stored at 2°C - 8°C for up to 3 days. Serum or plasma specimens may be stored at -20ºC for up to 9 days. Specimens should not be frozen and thawed repeatedly.
  • Frozen specimens must be completely thawed and mixed well prior to testing. Centrifuge the specimen to remove the sediment if with visible particulate matter.
  • Severe lipid, hemolysis or turbidity specimens are not recommended

For fingerstick whole blood

  • Clean the area to be lanced with an alcohol pad,Massage and/or shake to stimulate blood flow towards the collection area
  • Use a sterile lancet, puncture the skin just off the center of the finger pad. Apply gentle pressure beside the point of the puncture. Wipe away the first drop of blood. Create a large drop of blood by applying pressure at the base of the finger and massaging upward.
  • Squeeze the pipette bulb to expel air. Draw fingertip blood into the pipet by gently releasing the bulb. The pipet is filled just up to 20ul (second line).
  • Whole blood specimen collected by fingerstick are tested immediately.

TEST PROCEDURE

Read the instructions carefully before using. Bring the Detection Cassette, Sample Buffer, and Sample to room temperature before testing

  • Allow the cassette, buffer and specimen to equilibrate to room temperature prior to testing.
  • Remove a cassette from the foil pouch by tearing at the notch and place it on a level surface.
  • Add 10μL of serum, plasma or 20uL fingerstick whole blood, whole blood to the sample hole of the cassette and then add 2-3 drops (80μL) of buffer to the sample hole.
  • As the test begins to work, purple color move across the result window in the center of the test device.
  • Wait for 15 minutes and read the results. Do not read results after 30 minutes

KEY TO SYMBOLS USED

OEM Neutralizing Antibody COVID-19 Test For Professional Testing 99.9 Percent 0 Materials Included   OEM Neutralizing Antibody COVID-19 Test For Professional Testing 99.9 Percent 1 Test Cassette
OEM Neutralizing Antibody COVID-19 Test For Professional Testing 99.9 Percent 2OEM Neutralizing Antibody COVID-19 Test For Professional Testing 99.9 Percent 3 Instructions for Use   OEM Neutralizing Antibody COVID-19 Test For Professional Testing 99.9 Percent 4 Date of
Manufacturer
OEM Neutralizing Antibody COVID-19 Test For Professional Testing 99.9 Percent 5 Consult Instructions   OEM Neutralizing Antibody COVID-19 Test For Professional Testing 99.9 Percent 6 Do Not Reuse
For Use
OEM Neutralizing Antibody COVID-19 Test For Professional Testing 99.9 Percent 7 Store at 2°C~30°C   OEM Neutralizing Antibody COVID-19 Test For Professional Testing 99.9 Percent 8OEM Neutralizing Antibody COVID-19 Test For Professional Testing 99.9 Percent 9 Catalogue Number
OEM Neutralizing Antibody COVID-19 Test For Professional Testing 99.9 Percent 10OEM Neutralizing Antibody COVID-19 Test For Professional Testing 99.9 Percent 11 Expiration Date   OEM Neutralizing Antibody COVID-19 Test For Professional Testing 99.9 Percent 12 Keep away from Sunlight
OEM Neutralizing Antibody COVID-19 Test For Professional Testing 99.9 Percent 13 Manufacturer   OEM Neutralizing Antibody COVID-19 Test For Professional Testing 99.9 Percent 14OEM Neutralizing Antibody COVID-19 Test For Professional Testing 99.9 Percent 15 Tests per Kit
OEM Neutralizing Antibody COVID-19 Test For Professional Testing 99.9 Percent 16OEM Neutralizing Antibody COVID-19 Test For Professional Testing 99.9 Percent 17 Lot Number   OEM Neutralizing Antibody COVID-19 Test For Professional Testing 99.9 Percent 18OEM Neutralizing Antibody COVID-19 Test For Professional Testing 99.9 Percent 19 In Vitro Diagnostic Medical Device
OEM Neutralizing Antibody COVID-19 Test For Professional Testing 99.9 Percent 20 Keep Dry      
OEM Neutralizing Antibody COVID-19 Test For Professional Testing 99.9 Percent 21 Guangzhou Decheng Biotechnology Co., LTD
Room 218, Building 2, No.68, Nanxiang Road, Science City, Huangpu District, 510000, Guangzhou P.R.China
TEL:+86-020-82557192
sales@dochekbio.com
www.dochekbio.com
 
OEM Neutralizing Antibody COVID-19 Test For Professional Testing 99.9 Percent 22 CMC Medical Devices & Drugs S.L. OEM Neutralizing Antibody COVID-19 Test For Professional Testing 99.9 Percent 23
C/ Horacio Lengo Nº 18, CP 29006,
Málaga, Spain

 

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