2019nCov Ag Rapid Test Kit

The COVID-19 IgG/IgM Rapid Test is a single use lateral flow immunoassay rapid test intended for qualitative detection and differentiation of anti-SARS-CoV-2 IgG and IgM antibodies in human serum and plasma or whole blood containing EDTA, heparin or citrate anti-coagulants. The OnSite COVID-19 IgG/IgM Rapid Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. For prescription use only. For in vitro diagnostic use only.

Currently, the laboratory method for detecting SARS-CoV-2 infection is RT-PCR. However, this method requires sophisticated equipment and highly trained laboratory technicians. Moreover, viral load decreases rapidly 9 or 10 days after onset of symptoms. During the acute phase of infection, the titer of IgM to SARS-CoV-2 rises rapidly and peaks around 2-3 weeks after the infection. SARS-CoV-2 specific IgG antibodies appear shortly after IgM and persist for months. It is unknown if SARS-CoV-2 infection leads to lifetime immunity or if a 2nd infection is possible. Nevertheless, the SARS-CoV-2 specific antibodies are useful markers for immune response and epidemiologic survey.

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

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
		service@dochekbio.com
		www.dochekbio.com
	CMC Medical Devices & Drugs S.L.
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	Málaga, Spain