Product Description

2019nCov Ag Rapid Test Kit

What is the advantage of a quantitative test?
This antibody test will provide a numerical result, which will indicate the strength of your antibody response to Covid-19. Your result will be specified on a scale of zero to three and will indicate whether your level of antibodies is low, medium, high, very high, or negative (i.e. you do not have levels of antibodies that can be detected by this test). In turn, this will determine whether you have had a weak, medium, strong, or very strong antibody immune response to the virus or the vaccine.

How accurate is this test?
This quantitative test is up to 20% more accurate than other antibody tests. In more severe cases of Covid-19, this test has a sensitivity of 100% and a specificity of 100%. In less severe cases, this test has a sensitivity of 86.9% and a specificity of 98.4%. This test can detect antibodies produced in asymptomatic cases of Covid-19.

What is the advantage of testing for IgG and IgM antibodies?
The body’s response to a Covid-19 infection varies significantly from person to person. This test will measure the level of two antibody types – IgG and IgM. This means that the test is useful to an additional number of people who may have IgM antibodies but have not yet developed detectable levels of IgG antibodies. You will receive separate results for IgG antibodies and IgM antibodies.

2019-nCoV IgG&IgM Antibody Rapid Test Kit

(Immunochromatography)

Catalog Number: 0524C2X001 0524C2X010

0524C2X020 0524C2X025

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

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

		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