antigen rapid test novel coronavirus Sars-Cov-2

Novel Coronavirus (SARS-Cov-2) Antigen Rapid

Test Cassette (swab)

Package Insert

A RAPID TEST FOR THE QUALITATIVE DETECTION OF NOVEL CORONAVIRUS
ANTIGENS IN NASOPHARYNGEAL SWAB.
For professional In Vitro Diagnostic Use Only.

 

INTENDED USE

The Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) is an in vitro

diagnostic test for the qualitative detection of novel coronavirus antigens in Nasopharyngeal

swab, using the rapid immunochromatographic method. The identification is based on the

monoclonal antibodies specific for the novel coronavirus antigen. It will provide information for

clinical doctors to prescribe correct medications.

 

SUMMARY

The novel coronaviruses belong to the βgenus. 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.

Severe acute respiratory syndrome - coronavirus- 2 (SARS-CoV-2) is an enveloped,

non-segmented Positive sense RNA virus. It is the cause of the Coronavirus-0 disease

(COVID-19) common to humans is contagious. SARS-CoV-2 has several structural proteins,

including spike (S), envelope (E), membrane (M) and nucleocapsid(N).

At present, there are many variants of the Novel coronavirus (SARS-CoV-2), and the N501Y

mutation and its approximate variants have attracted attention because their mutation position is

located in the spike glycoprotein's receptor-binding domain of the virus, thereby changing the

virus infected efficiency. In silico analysis demonstrated that the N501Y mutation did not alter the

primary and tertiary protein structure of the spike protein RBD domain. Therefore, its antigenicity

remains unchanged.

PRINCIPLE

The Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Device (swab) is an

immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to

Novel coronavirus.

The test strip is composed of the following three parts, namely sample pad, reagent pad and

reaction membrane. The reagent membrane contains the colloidal-gold conjugated with the

monoclonal antibodies against Novel coronavirus; the reaction membrane contains the

secondary antibodies for Novel coronavirus, and the polyclonal antibodies against the mouse

globulin, which are pre-immobilized on the membrane.

When the sample is received by the test, the conjugated solution from the reagent pad gets

dissolved and migrates along with the nasal sample. When the Novel coronavirus is present in

the sample, a complex is formed between the anti-Novel coronavirus conjugate and the virus will

be caught / detected by the specific anti- Novel coronavirus monoclonal coated on the T region.

Whether the sample contains the virus or not, the solution continues to migrate to encounter

another reagent (an anti-mouse IgG antibody) that binds the remaining conjugates, thereby

producing a red line on the region C.

Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) can detect both the

SARS-Cov-2 nucleoprotein as well as the SARS-Cov-2 spike protein. By ELISA, we determined

that the antibody we use binds to amino acids 511-531 of the SARS Cov-2 spike protein.

The detectability of genetic SARS-CoV-2 variants was tested by examining the sensitivity toward

recombinant SARS-Cov-2 spike proteins (319 to 541aa). In these tests, the Novel Coronavirus

(SARS-Cov-2) antigen-rapid test achieved the same values when detecting the B.1.1.7 (UK) and

B.1.351 (SA) variants as when detecting the standard variant.

 

 

 

 

REAGENTS

The reagent membrane contains the colloidal-gold conjugated with the monoclonal antibodies

against Novel coronavirus; the reaction membrane contains the secondary antibodies for Novel

coronavirus, and the polyclonal antibodies against the mouse globulin, which are

pre-immobilized on the membrane.

PRECAUTIONS

• For in vitro diagnostic use only.

• Do not use after the expiration date.

• Ensure foil pouch containing test device is not damaged before opening for use.

• Perform test at room temperature 15 to 30°C.

•Wear gloves when hanging the samples, avoid touching the reagent membrane and sample

window.

• All samples and used accessories should be treated as infectious and discarded according to

local regulations.

• Avoid using bloody samples.

STORAGE AND STABILITY

Store the Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) at room

temperature or refrigerated (2-30°C). Do not freeze. All reagents are stable until the expiration

dates marked on their outer packaging and buffer vial.

 

SPECIMEN COLLECTION AND PREPARATION

1. Specimen collection*:

It is applicable to the diagnosis of the Novel coronavirus from the samples of Nasopharyngeal

swab. Using freshly collected samples for optimal test performance. Inadequate sample

collection or improper sample handling may yield a false-negative result.

Completely insert the sterilized swab supplied in this kit into the nasal basin, and swab several

times to collect the epidermal cells of the mucus.

*As there are many UTM and VTM brands and manufacturers in the world, VTM and UTM

from different manufacturers have varying degrees of impact on the sensitivity and

specificity of the product. Therefore, please use freshly collected samples to obtain more

accurate results when using this product.

2. Specimen preparation:

1) Take out 1 bottle of Sample Extraction Buffer, remove the bottle cap, add all the extraction

buffer into the extraction tube.

2) Insert the swab into the extraction tube which contains Sample Extraction Buffer. Rotate the

swab inside the tube using a circular motion to roll the side of the extraction tube so that liquid is

expressed and reabsorbed from the swab, remove the swab. The extracted solution will be used

as test sample.

 

MATERIALS

Materials provided

·         Test Device

·          Package Insert

·          Sterilized Swab

·          Nozzle

·          Extraction Tube

·          Sample Extraction Buffer

·          Tube Stand*

*The 25-test package contains the tube stand the 5-test package use the test box itself as tube

stand.

Materials required but not provided

·         Timer

 

DIRECTIONS FOR USE

Allow the test, specimen, extraction buffer to equilibrate to room temperature (15-30°C)

prior to testing.

1. Completely insert the sterilized swab supplied in this kit into the nasal basin, and swab several

times to collect the epidermal cells of the mucus.

2. Unscrew the whole cap of the specimen collection tube, take out 1 bottle of Sample Extraction

Buffer, remove the bottle cap, add all the extraction buffer into the extraction tube.

3.Place the sterilized swab specimen in the sample extraction buffer. Rotate the swab for

approximately 10 seconds while pressing the head against the inside of the tube to release the

antigen in the swab.

4.Remove the sterilized swab while squeezing the sterilized swab head against the inside of

Buffer as you remove it to expel as much liquid as possible from the swab. Discard the sterilized

swab in accordance with your biohazard waste disposal protocol.

5. Screw on and tighten the cap onto the specimen collection tube, then shake the specimen

collection tube vigorously to mix the specimen and the sample extraction buffer.
See illustration 4

 

 

When the sample is ready, take the following procedures to complete the test:

1, Remove the test device from the sealed foil pouch and use it as soon as possible. Best results

will be obtained if the assay is performed immediately after opening the foil pouch. Put the test

device on a clean and flat surface.

2, Transfer 3 drops of sample into the sample well of test device vertically, start the timer, read

the result at 10~20 minutes. Don’t interpret the result after 20 minutes.

 

INTERPRETATION OF RESULTS

(Please refer to the illustration above)

POSITIVE: Two red lines appear. One red line appears in the control region(C), and one red line

in the test region(T). The shade of color may vary, but it should be considered positive whenever

there is even a faint line.

NEGATIVE: Only one red line appears in the control region(C), and no line in the test region(T).

The negative result indicates that there are no Novel coronavirus particles in the sample or the

number of viral particles is below the detectable range.

INVALID: No red line appears in the control region(C). The test is invalid even if there is a line on

test region(T). Insufficient sample volume or incorrect procedural techniques are the most likely

reasons for control line failure. Review the test procedure and repeat the test using a new test

device. If the problem persists, discontinue using the test kit immediately and contact your local

distributor.

 

LIMITATIONS

• The Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) is an acute-phase

screening test for qualitative detection. Sample collected may contain antigen concentration

below the reagent’s sensitivity threshold, so a negative test result does not exclude infection with

novel coronavirus

• The Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) detects viable and

non-viable novel coronavirus antigen. Test performance depends on antigen load in the sample

and may not correlate with cell culture performed on the same sample. A positive test does not

rule out the possibility that other pathogens may be present, therefore, the results must be

compared with all other available clinical and laboratory information to make an accurate

diagnosis.

• A negative test result may occur if the level of extracted antigen in a specimen is below the

sensitivity of the test or if poor quality specimen is obtained

• Performance of the test has not been established for monitoring antiviral treatment of novel

coronavirus.

• Positive test results do not rule out co-infections with other pathogens.

• Negative test results are not intended to rule in other coronavirus infection except the

SARS-Cov-2.

• Children tend to shed virus for longer periods of time than adults, which may result in

differences in sensitivity between adults and children List.

• A negative result may occur if the concentration of antigen in a specimen is below the detection

limit of the test or if the specimen was collected or transported improperly, therefore a negative

test result does not eliminate the possibility of SARS-Cov-2 infection, and should be confirmed

by viral culture or PCR.

 

PERFORMANCE CHARACTERISTICS

Clinical Evaluation

Clinical evaluation was performed to compare the results obtained by Novel Coronavirus

(SARS-Cov-2) Antigen Rapid Test Cassette (swab) and PCR. The results were summarized

below:

Table: Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab) vs. PCR

Method		2019-nCoV Nucleic Acid Test Kit (RT-PCR)		Total Results
The Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (Swab)	Results	Positive	Negative
	Positive	201	0	201
	Negative	8	450	458
Total Results		209	450	659

 

 

 

 

 

Clinical sensitivity = 201/209=96.17 % (95%CI* 92.51% to 98.17%)

Clinical specificity = 450/450＞99.9% (95%CI* 98.98% to 100%)

Accuracy: (201+450)/ (201+0+8+450) *100%=98.79% (95%CI* 97.58% to 99.43%)

*Confidence Interval

Limit of Detection (LOD)

 

2019-nCoV Strain Tested	Realy Tech product
Stock 2019-nCoV Concentration	1 X 106 TCID50/mL
Dilution	1/100	1/200	1/400	1/800	1/1600
Concentration in Dilution tested (TCID50/ml)	1X104	5X103	2.5X 103	1.25X103	6.25X102
Call rates of 20 replicates near cut-off	100(20/20)	100(20/20)	100(20/20)	95(19/20)	10(2/20)
Limit of detection (LOD) per Virus Strain	1.25 X 103 TCID50/mL

 

 

Cross Reaction

 

The test results are below the corresponding concentration of the substances in the table below,

which has no effect on the negative and positive test results of this reagent, and there is no

cross-reaction.

 

 

Virus/Bacteria/Parasite	Strain	Concentration
MERS-coronavirus
		1.5×105TCID /ml 50
Adenovirus	Type 3	7.5×105TCID /ml 50
	Type 5	4.5×105TCID /ml 50
	Type 7	1.0×105TCID /ml 50
	Type 8	1.0×105TCID /ml 50
	Type 11	2.5×105TCID /ml 50
	Type 18	2.5×105TCID /ml 50
	Type 23	6.0×105TCID /ml 50
		1.5×105TCID /ml 50
Influenza A		ID50/ml
	H1N1 WS/33	2.0×107TCID /ml 50
	H1N1 A/Mal/302/54	1.5×107TCID /ml 50
	H1N1 New Caledonia	7.6×107TCID /ml 50
	H3N2 A/Hong Kong/8/68	4.6×107TCID /ml 50
Influenza B	Nevada/03/2011	1.5×107TCID /ml 50

 

	B/Lee/40	8.5×107TCID /ml 50
	B/Taiwan/2/62	4.0×107TCID /ml 50
Respiratory syncytial virus	N/A	2.5×105TCID /ml 50
Legionella pneumophila	Bloomington-2	1 X 105 CFU/ml
	Los Angeles-1	1 X 105 CFU/ml
	82A3105	1 X 105 CFU/ml
Rhinovirus A16	N/A	1 X 105 CFU/ml
Mycobacterium tuberculosis	K	1 X 105 CFU/ml
	Erdman	1 X 105 CFU/ml
	HN878	1 X 105 CFU/ml
	CDC1551	1 X 105 CFU/ml
	H37Rv	1 X 105 CFU/ml
Streptococcus pneumonia	4752-98 [Maryland (D1)6B-17]	5 1 X 10 CFU/ml
	178 [Poland 23F-16]	5 1 X 10 CFU/ml
	262 [CIP 104340]	5 1 X 10 CFU/ml
	Slovakia 14-10 [29055]	5 1 X 10 CFU/ml
Streptococcus pyrogens	Typing strain T1 [NCIB 11841, SF 130]	5 1 X 10 CFU/ml
Mycoplasma pneumoniae	Mutant 22	5 1 X 10 CFU/ml
	FHstrainof EatonAgent [NCTC 10119]	1 X 105 CFU/ml
	36M129-B7	5 1 X 10 CFU/ml
Coronavirus	229E	1.5×105TCID50/ml
	OC43	1.5×105TCID50/ml
	NL63	1.5×105TCID50/ml
	HKU1	1.5×105TCID50/ml
Human etapneumovirus (hMPV) 3 Type B1	Peru2-2002	1.5×105TCID50/ml
Human Metapneumovirus (hMPV) 16 Type A1	IA10-2003	1.5×105TCID50/ml
Parainfluenza virus	Type 1	1.5×105TCID50/ml
	Type 2	1.5×105TCID50/ml
	Type 3	1.5×105TCID50/ml
	Type 4A	1.5×105TCID50/ml

 

Interfering Substances Reaction

When tested using the Novel Coronavirus (SARS-Cov-2) Antigen Rapid Test Cassette (swab), there was no interference between the device reagents and the Potential interference substances listed in below table that would create false positive or negative results for SARS-Cov-2 antigen.

Substance	Concentration	Substance	Concentration
Mucin	100μg/mL	Acetylsalicylic acid	3.0 mM
Whole Blood	5% (v/v)	Ibuprofen	2.5 mM
Biotin	100μg/mL	Mupirocin	10 mg/mL
Neo-Synephrine (Phenylephrine)	5%(v/v)	Tobramycin	10μg/mL
Afrin Nasal Spray (Oxymetazoline)	5%(v/v)	Erythromycin	50uM
Saline Nasal Spray	5%(v/v)	Ciprofloxacin	50uM
Sodium Cromoglycate	10 mg/mL	Ceftriaxone	110mg/mL
Olopatadine Hydrochloride	10 mg/mL	Meropenem	3.7μg/mL
Zanamivir	5 mg/mL	Tobramycin	100μg/mL
Oseltamivir	10 mg/mL	Histamine Hydrochloride	100μg/mL
Artemether-lumefantrine	50uM	Peramivir	1mmol/mL
Doxycycline hyclate	50uM	Flunisolide	100μg/mL
Quinine	150uM	Budesonide	0.64nmol/ L
Lamivudine	1 mg/mL	Fluticasone	0.3ng/mL
Ribavirin	1 mg/mL	Lopinavir	6μg/mL
Daclatasvir	1 mg/mL	Ritonavir	8.2mg/mL
Acetaminophen	150uM	Abidor	417.8ng/mL
Pooled human nasal wash	N/A	/	/

 

 

 

Symbol	Meaning	Symbol	Meaning
	In vitro diagnostic medical device		Storage temperature limit
	Manufacturer		Authorized representative in the European Community
	Date of Manufacture		Use by date
	Do not use		Consult instructions for use
	Batch code		Meet the requirements of EC Directive 98/79/EC

 

 

BOLS

 

 

 

Hangzhou Realy Tech Co., Ltd.

#2 Building, No. 763, Yuansha Village, Xinjie Street, Xiaoshan District, 311200 Hangzhou City, Zhejiang Province, PEOPLE'S REPUBLIC OF CHINA

 

 

EC/REP

Luxus Lebenswelt GmbH

Kochstr. 1, 47877, Willich, Germany

 

Number: 1100000417

Version:3.6

Effective Date:2021-10-29