The 2019-nCOV is a new type of β-COV.Can cause viral pneumonia, the main clinical manifestations are fever, fatigue, dry cough, etc.A small number of patients were accompanied by nasal congestion, runny nose, sore throat, diarrhea and other symptoms.Critical cases often develop dyspnea and / or hypoxemia after a week, with severe conditions rapidly progressing to acute respiratory distress syndrome, septic shock, difficult to correct metabolic acidosis, and coagulation dysfunction.

This product was qualitatively tested by lateral flow immunoanalysis for 2019-nCoV Ag in the saliva / sputum samples of suspected patients.In the acute phase of the infection, antigens are usually detected in salivary / sputum samples.Positive results indicate the presence of viral antigens, but the clinical relevance of patient history and other diagnostic information is also necessary to determine the infection status.A positive result cannot rule out a bacterial infection or a co-infection with other viruses.The pathogens detected may not be the exact cause of the disease.Negative results cannot exclude 2019-nCoV infection and should not be used as a basis for treatment or patient management decisions (including infection control decisions).If the result is negative, a final decision should be made combining the patient's recent contact history, medical history and presence of clinical signs and symptoms consistent with 2019-nCoV and confirmed by nucleic acid analysis if necessary.

Principle of Detection

This kit is an immunoassay based on the principle of dual-antibody sandwich technology.As an indicator marker, the labeled 2019-nCoV monoclonal antibody was sprayed on the binding pad.During the test, 2019-nCoV Ag in the sample binds to the labeled 2019-nCoV monoclonal antibody to form the Ag-Ab complex.This complex migrated upwards on the membrane by capillary effects until it was captured by another 2019-nCoV monoclonal antibody precoated on the test line to form a sandwich complex.If 2019-nCoV Ag, exists in the sample, a 1 red-band appears in the T region of the explanatory window.Otherwise, this is a negative result.Control line (C) is used for program control and should always appear if the test program is performed correctly.

Main Components

The kit consisted of test cards, sample buffer, and swabs.

Test card: composed of aluminum foil bag, desiccant, test paper and plastic card.Among them, the test paper consists of water absorbent paper, nitrofiber membrane, sample pad, adhesive pad and rubber sheet.Nitro fiber membrane T line (test line) was coated with 2019-nCOV Ab,C line (QC line) coated with goat anti-mouse polyclonal Ab, with a binding pad containing labeled 2019-nCOV Ab.

Sample buffer: phosphate, sodium azide, etc.

Storage Conditions and Validity

Stay at 2℃ to 30℃, tentatively valid for 18 months.

The aluminum foil bag is valid for one hour after unpacking.

Production batch number: see the label for details.

Validity period: See the label for details.

Sample Requirements

(1) Collection of saliva samples: Do not eat or drink water for 30 minutes before the collection of saliva samples, including chewing gum or using tobacco products.A tip of the tongue was against the maxilla and saliva was collected at the root of the tongue.The sterile disposable cotton swab was placed under the root of the tongue for at least 10 seconds, fully immersed in the saliva and rotated more than 5 times.(see chart 1)

Note: If saliva samples are improperly collected.

Figure 1 Methodsfor saliva sample collection

Figure 2 Methods for sputum sample collection

(2) Sputum specimen collection: after rinsing with clear water, vigorously cough out the sputum liquid and put it into the specimen bag, and wipe the specimen with a disposable sterile cotton swab.(see chart 2)

(3) Sample Treatment: The collected samples shall be treated with the sample buffer provided in this kit as soon as possible (should not be treated immediately, the samples shall be stored in dried, sterilized, tightly sealed containers) and kept for inspection.2℃ ~8℃ shall not exceed 24h, -70℃ for a long time (but avoid repeated freeze and thaw).

Test Method

Please read the instructions carefully before testing.Please put all reagents back to room temperature and testing should be conducted at room temperature.

1. Sample treatment (see Figure 3)

(1) inserted the sample swab into the sample buffer and rotated about 10 times near the inner wall so that the sample was dissolved as much in solution as possible.

(2) squeezed the swab tip along the inner wall to flow the liquid into the tube, removed and discarded the swab.

(3) Cover with the drops.

Figure 3 Sample processing

Figure 4 Test procedure

2. test procedure (see Figure 4)

The (1) takes out the test card.

(2) Add the treated sample extract 2 drops (approximately 80 L) to the sample hole of the test card and then start the timer.

(3) Place the card at room temperature for 15 minutes to read the results.The results were invalid after 20 minutes.

Interpretation of Test Results

Interpretation of the test card (see Figure 5):

Invalid 1. result: Quality control line (line C) shall be re-detected.

2. negative results: Quality control line (C line), red ribbon, coloring.

3. positive results: T wo red bands of test line (line T) and quality control line (line C) are colored.

Figure 5 Interpretation of test results

Limitation of Test Method

1, This product is qualitative detection and is only used to assist in vitro diagnosis.

2, This product is suitable for saliva and sputum samples.Other sample types may have inaccurate or invalid results.

3., without patient sputum samples, should be tested using nasopharyngeal swab samples.

4. ensures that the appropriate amount of samples is added for testing.Too much or too little sample size may lead to inaccurate results.

5, The test results of this reagent are only for clinical reference, and should not be used as the sole basis for clinical diagnosis and treatment.The final diagnosis of the disease should be made after a comprehensive evaluation of all clinical and laboratory outcomes.

Product Performance Indicators

1, detection limit: The inactivated SARS-CoV-2 virus culture was used in this study, and the minimum detection limit of the kit was 6102TCID50/mL.

2, uses enterprise reference products for testing, and the results shall meet the requirements of enterprise reference products.

2.1 Qualified rate of positive control products: enterprise positive control products P1-P5 were positive as positive.

2.2 Qualified rate of negative control products: all N1-N10 of enterprise negative control products are tested negative.

2.3 Test limit: the lowest test limit reference product L1-L3,L1 of test enterprises is negative and L2 and L3 is positive.

2.4 Reproducibility: J1 and J2 were detected, and each was positive 10 times.

3, cross-reaction: The following concentrations of microbes and viruses were added to the samples at the specified concentrations to assess their potential interference with the 2019-nCoV Ag test program.The results showed no cross-reaction and no interference by various microbes and viruses.

SN	Microorganisms	Concentration	Cross reaction
1	Coronavirus (HKU1, OC43, NL63 and 229E)	1.0×10⁵TCID₅₀/mL	No
2	Influenza A H1N1 (novel influenza A H1N1 virus (2009), seasonal H1N1 influenza virus), H3N2, H5N1, H7N9	1.0×10⁵TCID₅₀/mL	No
3	Influenza B (Yamagata strain, Victoria strain)	2.5×10⁵TCID₅₀/mL	No
4	Respiratory syncytial virus	2.8×10⁵TCID₅₀/mL	No
5	Group A, B, C of rhinovirus	2.0×10⁵TCID₅₀/mL	No
6	Type 1, 2, 3, 4, 5, 7, 55 of adenovirus	2.0×10⁵TCID₅₀/mL	No
7	Group A, B, C and D of enterovirus	2.0×10⁵TCID₅₀/mL	No
8	EB virus	2.0×10⁵TCID₅₀/mL	No
9	Measles virus	2.0×10⁵TCID₅₀/mL	No
10	Human cytomegalovirus	2.0×10⁵TCID₅₀/mL	No
11	Rotavirus	2.0×10⁵TCID₅₀/mL	No
12	Norovirus	2.0×10⁵TCID₅₀/mL	No
13	Mumps virus	2.0×10⁵TCID₅₀/mL	No

14	Varicella-zoster virus	2.0×10⁵TCID₅₀/mL	No
15	Mycoplasma pneumoniae	1.0×10⁶CFU/mL	No
16	Legionella pneumophila	1.0×10⁶CFU/mL	No
17	Haemophilus influenzae	1.0×10⁶CFU/mL	No
18	Streptococcus pyogenes (group A)	1.0×10⁶CFU/mL	No
19	Streptococcus pneumoniae	1.0×10⁶CFU/mL	No
20	Escherichia Coli	1.0×10⁶CFU/mL	No
21	Pseudomonas aeruginosa	1.0×10⁶CFU/mL	No
22	Neisseria meningitidis	1.0×10⁶CFU/mL	No
23	Candida albicans	1.0×10⁶CFU/mL	No
24	Staphylococcus aureus	1.0×10⁶CFU/mL	No

4. interfering actor: assess potential interference to the 2019-nCoV Ag test item to add the drug at the following concentrations at the indicated concentrations.The results showed that the various drugs did not interfere with the detection results of this reagent.

Interfering substances	Concentration	Interfering substances	Concentration
Mucoprotein	1mg/mL	Ribavirin	0.4mg/mL
Whole Blood	1%	Fluticasone	0.5mg/mL
Oxymetazoline	10mg/mL	Dexamethasone	5 mg/mL
Histamine hydrochloride	10mg/mL	Triamcinolone acetonide	5 mg/mL
Tobramycin	1mg/mL	Levofloxacin	0.2 mg/mL
Oseltamivir	1mg/mL	Azithromycin	0.1 mg/mL
Zanamivir	1mg/mL	Ceftriaxone	0.4 mg/mL
Arbidol	0.5mg/mL	Meropenem	0.2 mg/mL

5. hook effect: No hook effect was observed in the high concentration range of 1.0106 TCID50/mL with inactivated 2019-nCoV cultures.

6. clinical study: The RT-PCR detection reagent was used as a contrast reagent to evaluate the saliva and sputum specimens, respectively.For each sample size, 120 positive and 120 negative samples were selected (RT-PCR test) and detected with Zhong xiu reagent.The results are summarized as follows:

Precautions

1. This product is used for in vitro diagnosis.

2, This product is a disposable product, which is not recyclable.

Read the instructions carefully before 3, operation and experiment in strict accordance with the reagent instructions.

4, avoids experiments in harsh environmental conditions (including high concentrations of corrosive gases including 84 disinfectant, dust, sodium hypochlorite, acid-alkali, or acetaldehyde).Laboratory disinfection should be carried out after the experiment.

5. samples and used reagents shall be considered as potentially infectious and treated in accordance with local regulations.

6, reagent shall be used during the validity period marked in the outer package.The test card shall be used as soon as possible after removal from the foil bag to prevent damp.

Logo interpretation

	Do not re-use		Store at 2℃～30℃
	Consult instructions for use		In vitro diagnostic medical device
	Batch code		Use-by date
	Keep dry		Keep away from sunlight
	Authorized representative in the European Community		Manufacturer

Basic Information

ZHONGXIU SCIENCE AND TECHNOLOGY CO.,LTD

Dingluan industrial zone ,Changyuan City,453400,P.R.CHINA

Tel:+86-371-55016575

Email:zosbio@zosbio.com

Web:www.zosbio.com

SUNGO Europe B.V.

Olympisch Stadion 24, 1076DE Amsterdam, Netherlands

Company profile

Coronavirus Disease Rapid Ag Test Kit Sputum Saliva Ag Test

Zhongxiu Science And Technology Co.,Ltd., is a high-tech enterprise engaged in the research and development, production and operation of in vitro diagnostic products. The in vitro diagnostic products developed by the company cover POCT series, microbial series, biochemical series and immune series reagents and supporting instruments.
The company has always adhered to the core concept of "fast and accurate, living up to life", committed to providing society with excellent products and services, and contributing to the cause of human health.

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