Product Description

2019nCov Ag Rapid Test Kit

Kits Features
The detection of SARS-CoV-2 neutralizing antibodies offers important information for evaluating immune responses to COVID-19. It has multiple applications such as studies of human immunity and vaccine development among others.
CD’ SARS-CoV-2 Neutralizing Antibody ELISA Kit functions as a simple, qualitative indicator of positive or negative samples. Disease-free positive and negative plasma controls are supplied to confirm the assay is performing as expected.

The format of our ELISA (in which neutralizing antibodies must recognize the SARS-CoV-2 spike receptor binding domain to inhibit ACE2 binding) provides an efficient and effective screening tool for determining functional antibody neutralization capabilities.

The entire detection process takes about 80 minutes, while traditional neutralization experiments require cell culture, which usually takes 2-3 days to complete the test.
Since a sterile environment is not required, the detection operation can be performed under general experimental conditions, which is more convenient.

PRINCIPLE OF THE TEST

This test uses double-antibody sandwich to legally detect the antigen of novel coronavirus (2019-nCoV) in saliva samples. During detection, the gold labeled anti-2019-nCoV monoclonal antibody in the labeling pad binds to the 2019-nCoV antigen in the sample to form a complex, and the reaction complex moves forward along the nitrocellulose membrane under the action of chromatography, it is captured by the anti-2019-nCoV monoclonal antibody pre-coated by the detection zone (T) on the nitrocellulose membrane, and finally a red color reaction line is formed in the T zone. If the sample does not contain 2019-nCoV antigen, a red color reaction line cannot be formed in the T zone. Regardless of whether the sample to be tested contains 2019-nCoV antigen, a red reaction line will always form in the quality control area (C).

MATERIALS AND COMPONENTS

INTENDED USE

2019-nCoV RBD Antibody Rapid Test is an immunochromatographic assay for rapid, qualitative detection of the novel coronaviruses (2019-nCoV) spike protein receptor-binding domain (RBD) antibodies in human fingerstick whole blood, venipuncture whole blood, serum or plasma specimen.

The Test is used to monitor the presence of 2019-nCoV RBD antibodies in subjects vaccinated with the novel coronavirus vaccine or in people infected with the novel coronavirus.

2019-nCoV RBD Antibody Rapid Test can be used to assess vaccine efficacy after vaccination or whether 2019-nCoV RBD antibodies are produced in human body after infection with novel coronavirus.

For in vitro diagnostic use only.

For professional use only.

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.

The genome of coronavirus encodes four structural proteins, namely Nucleoprotein, small membrane protein, membrane protein and Spike protein (S protein). The virus receptor-binding domain (RBD) is an important domain in Spike protein and is the main structural domains for inducing neutralizing antibodies and T-cell immune responses. The viral spike protein binds the host receptor angiotensin-converting enzyme 2 (ACE2) via the receptor-binding domain (RBD), and thus is believed to be a major target to block viral entry. Neutralizing antibodies that had receptor binding motif of RBD compete strongly with human ACE2.

PRINCIPLE OF THE TEST

2019-nCoV RBD Antibody Rapid Test is based on the principle of double antigen sandwich immunoassay for determination of 2019-nCoV RBD antibodies in human whole blood, serum and plasma specimen.

During detection, When the 2019-nCoV RBD antibodies level in the specimen is at or above the detection limit of the test, the RBD antibodies bound to the colloidal gold labeled 2019-nCoV recombinant antigen and form an immune complex which are captured by RBD immobilized in the Test Region (T) of the nitrocellulose membrane, and this produces a colored test band that indicates a positive result. When the 2019-nCoV RBD antibodies level is zero or below the detection limit, there is no visible colored band in the Test Region (T) of the device. This indicates a negative result.

To serve as a procedure control, a colored line will appear at the Control Region (C), if the test has been performed properly.

MATERIALS AND COMPONENTS

Note: The components in different batches of the kit cannot be mixed.

Materials may require but not provided

• Transfer pipette
• Timer

STORAGE AND STABILITY

• Store at 2°C - 30°C in the sealed pouch up to the expiration date printed on the package, forbidden to store under 2°C and avoid using expired products.
• The test cassette is used within 15 minutes after taking out from the foil envelope. Buffer solution are re-capped in time after use.
• MFD date and EXP date: marked on the label. The product will be expired after 24 months

SAMPLE REQUIREMENTS

The test can be performed with fingerstick whole blood, venous whole blood, serum and plasma.

For Fingerstick Whole Blood:

1. Clean the area to be lanced with an alcohol pad. Allow the finger to dry thoroughly.

2. 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.

3. Collect a fingerstick whole blood specimen using a blood collection tube with suitable anticoagulant (containing EDTA or Heparin). Other anticoagulants have not been validated and may give incorrect result.

4. If blood flow is inadequate, the subject’s finger may have to be gently massaged at the finger base to produce several droplets of sufficient volume.

5. Draw 20μL of fingerstick whole blood from the blood collection tube with the disposable dropper. Whole blood specimen collected by fingerstick should be tested immediately.

For Venous Whole Blood:

1. According to standard venous blood collection procedure, collect a venipuncture whole blood specimen using a blood collection tube with suitable anticoagulant (containing EDTA or Heparin). Other anticoagulants have not been validated and may give incorrect result.

KEY TO SYMBOLS USED

		Materials Included			Test Cassette
		Instructions for Use			Date of
					Manufacturer
		Consult Instructions			Do Not Reuse
		For Use
		Store at 2°C~30°C			Catalogue Number
		Expiration Date			Keep away from Sunlight
		Manufacturer			Tests per Kit
		Lot Number			In Vitro Diagnostic Medical Device
		Keep Dry
		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
	CMC Medical Devices & Drugs S.L.
	C/ Horacio Lengo Nº 18, CP 29006,
	Málaga, Spain