2019-NCOV is a new type of β -CoV. Can cause viral pneumonia, the main clinical manifestations are fever, fatigue, dry cough and so on. A few patients with nasal congestion, runny nose, sore throat, diarrhea and other symptoms. Critical cases often develop dyspnea and/or hypoxemia after one week, and in severe cases progress rapidly to acute respiratory distress syndrome, septic shock, difficult-to-correct metabolic acidosis, and cotting dysfunction.

This product qualitatively detects 2019-NCOV Ag in saliva/sputum samples from suspected patients using side-flow immunoassay. In the acute phase of infection, antigens are usually detected in saliva/sputum samples. A positive result indicates the presence of viral antigens, but clinical relevance of the patient's history and other diagnostic information is also necessary to determine the status of the infection. A positive result does not rule out bacterial infection or co-infection with other viruses. The detected pathogen may not be the exact cause of the illness. A negative result does not exclude 2019-NCOV infection and should not be used solely as a basis for treatment or patient management decisions, including infection control decisions. If the result is negative, a final decision should be made based on the patient's recent exposure history, medical history, and presence of clinical signs and symptoms consistent with 2019-NCOV, and nucleic acid analysis should be performed to confirm if necessary.

Principle of Detection

This kit is an immunoassay based on double antibody sandwich technology. As an indicator, the labeled 2019-NCOV monoclonal antibody was sprayed on the binding mat. During the test, the 2019-NCoV Ag in the sample binds to the labeled 2019-NCOV monoclonal antibody to form the Ag-AB complex. This complex migrates upward on the membrane by capillary effect until it is captured by another 2019-NCOV monoclonal antibody precoated on the test line, forming the sandwich complex. If 2019-NCOV Ag is present in the sample, a red band will appear in the T region of the interpretation window. Otherwise, it's a negative result. The control line (C) is used for program control and should always be displayed if the test program is executed correctly.

Main Components

The kit consists of a test card, sample buffer and swab.

Test card: by aluminum foil bag, desiccant, test strip and plastic card composition. The strip consists of absorbent paper, nitrocellulose film, sample pad, adhesive pad and rubber sheet. Nitrocellulofiber membrane LINE T (test line) is coated with 2019-NCOV Ab, line C (quality control line) is coated with goat anti-rat polyclonal Ab, and the bond pad contains the labeled 2019-NCOV Ab.

Sample buffer: phosphate, sodium azide, etc.

Storage Conditions and Validity

It is kept at 2℃ ~ 30℃ and the validity period is tentatively set at 18 months.

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

Batch Number: see label for details.

Expiry date: See label for details.

Sample Requirements

(1) Saliva sample collection: Do not eat or drink, including chewing gum or tobacco products, 30 minutes before saliva sample collection. Press the tip of your tongue against your upper jaw and collect saliva at the base of your tongue. Place a sterile disposable cotton swab under the base of your tongue for at least 10 seconds, immerse it completely in saliva and rotate it more than five times. (See Figure 1)

Note: False negative results may occur if saliva samples are not collected properly.

Figure 1 Methodsfor saliva sample collection

Figure 2 Methods for sputum sample collection

(2) Sputum specimen collection: after rinsing with water, cough up sputum and put it into the specimen bag. Wipe the specimen with a disposable sterile cotton swab. (See Figure 2)

(3) Sample processing: The collected samples should be treated with sample buffer solution provided by the kit as soon as possible (if not immediately treated, the samples should be stored in a dry, sterilized, tightly sealed container) and stored for inspection. 2℃ ~ 8℃ for no more than 24h, long-term storage at -70℃ (but avoid repeated freeze-thaw).

Test Method

Please read the instructions carefully before taking the test. Please put all reagents back to room temperature before test, test should be carried out at room temperature.

1. Sample processing (see Figure 3)

(1) Insert the sample swab into the sample buffer and rotate it close to the inner wall about 10 times, so that the sample can be dissolved in the solution as much as possible.

(2) Squeeze the tip of the swab along the inner wall of the tube so that the liquid flows into the tube as much as possible, remove and discard the swab.

(3) Cover the dropper.

Figure 3 Sample processing

Figure 4 Test procedure

2. Test procedure (see Figure 4)

(1) Take out the test card.

(2) Add 2 drops of the processed sample extract (about 80μL) to the adding well of the test card, and then start the timer.

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

Interpretation of Test Results

Test card interpretation (see Figure 5) :

1. Invalid result: The quality control line (LINE C) without reaction line is invalid and needs to be tested again.

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

3. Positive results: Two red strips of test line (T line) and quality control line (C line) are colored.

Figure 5 Interpretation of test results

Limitation of Test Method

1. This product is a qualitative test and is only used for in vitro auxiliary diagnosis.

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

3. If a sputum sample from the patient is not available, a nasopharyngeal swab sample should be used for testing.

4. Make sure to add the right amount of samples for testing. Too many or too few samples can lead to inaccurate results.

5. The test results of this reagent are for clinical reference only, 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 results.

Product Performance Indicators

1. Detection limit: Inactivated SARS-COV-2 virus culture was used in this study, and the minimum detection limit of the kit was 6×102TCID50/mL.

2. Use the reference product of the enterprise for testing, and the result should meet the requirements of the reference product of the enterprise.

2.1 Qualification rate of positive control substance: P1-P5 positive control substance of the enterprise were all tested positive.

2.2 Qualified rate of negative control substance: Negative control substance N1-N10 of the enterprise was tested negative.

2.3 Limit of detection: The minimum limit of reference materials for detection enterprises is L1-L3, L1 is negative, L2 and L3 are positive.

2.4 Reproducibility: J1 and J2 were both positive for 10 times of repeated reference.

3. Cross-reaction: The following concentrations of microorganisms and viruses are added to the sample in accordance with the specified concentration to evaluate their potential interference to the 2019-NCOV Ag test item. The results showed that there was no cross reaction and no interference from various microorganisms 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 substances: Add the following concentrations of drugs to the sample according to the specified concentration to evaluate its potential interference to the 2019-NCOV Ag detection item. The results showed that all kinds of drugs did not interfere with the detection results of the 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 concentration range of 1.0×106TCID50/mL by inactivated 2019-ncov culture.

6. Clinical study: RT-PCR detection reagents were used as contrast reagents to evaluate saliva and sputum samples respectively. 120 positive samples and 120 negative samples were selected for each sample size (RT-PCR detection) and tested with Zhong Xiu reagent. The results are summarized as follows:

Precautions

1. This product is only used for in vitro diagnosis.

2, this product is a disposable product, can not be recycled.

3. Read the instructions carefully before operation, and perform experimental operations in strict accordance with the reagent instructions.

4, avoid in harsh environmental conditions (containing 84 disinfectant, sodium hypochlorite, acid and alkali or acetaldehyde and other high concentration of corrosive gas, dust and other environment). Laboratory disinfection should be carried out after the experiment.

5. All samples and used reagents should be treated as potentially infectious substances and disposed of in accordance with local regulations.

6. Reagents should be used within the validity period marked on the outer package. The test card should be used as soon as possible after it is removed from the aluminum foil bag to prevent moisture.

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

NCoV Ag Saliva / Sputum Ag Rapid Test Kit ( Immunochromatography )

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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