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Coronavirus Saliva Sputum Ag Rapid Test Kit Usage Manual Principle Of Detection

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Coronavirus Saliva Sputum Ag Rapid Test Kit Usage Manual Principle Of Detection

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Brand Name : ZOSBIO

Model Number : 2019-NCoV Neutralizing Antibody

Certification : CE BfArm

Place of Origin : China

MOQ : To be negotiated

Price : To be negotiated

Supply Ability : 10000 Kit/Kit per Day

Delivery Time : To be negotiated

Packaging Details : Kit

Product name : 2019-NCoV Ag Saliva/Sputum Rapid Test Usage Manual Principle Of Detection

Composition : Detection card, sample buffer

Storage conditions : 2℃~30℃

term of validity : 18 months

Expiration date : See label for details

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2019-NCoV Ag Saliva/Sputum Rapid Test Usage Manual Principle Of Detection

Intended Use


The kit is used for qualitative detection of 2019-nCoV Ag. Collected from human saliva/sputum samples.

2019-nCOV is a new type of β-COV, which can cause viral pneumonia. The main clinical manifestations are fever, fatigue, dry cough, etc. A few patients are accompanied by nasal congestion, runny nose, sore throat, diarrhea and other symptoms. Severe cases often suffer from dyspnea and/or hypoxemia after one week, and those with severe illness rapidly develop into acute respiratory distress syndrome, septic shock, metabolic acidosis, and coagulation dysfunction.

The 2019-nCoV Ag in saliva/sputum samples of suspected patients was qualitatively detected by sidestream immunoassay. In the acute phase of infection, antigens are usually detected in saliva/sputum samples. The positive results showed that there were virus antigens, but the clinical correlation between the patient's medical history and other diagnostic information was also a necessary condition for determining the infection status. Positive results can not rule out bacterial infection or combined infection with other viruses. The detected pathogen may not be the exact cause of infection. Illness. Negative results cannot rule out 2019-nCoV infection, and should not be used as the basis for treatment or patient management decisions (including infection control decisions). If the result is negative, the final decision should be made according to the patient's recent exposure history, medical history and whether there are clinical signs and symptoms consistent with those of 2019-nCoV, and confirmed by nucleic acid analysis when necessary.

Principle of Detection


This kit is an immunoassay based on the principle of double antibody sandwich technology. As an indicator, the labeled 2019-nCoV monoclonal antibody was sprayed on the binding pad. In the test process, the 2019-nCoV Ag in the sample and the labeled 2019-nCoV monoclonal antibody formed an Ag-Ab complex. This complex migrated upward on the membrane by capillary effect until it was captured by another 2019-nCoV monoclonal antibody pre-coated on the test line, forming a sandwich complex. If 2019-nCoV Ag exists in the sample, it means that a red band appears in the t area of the window. Otherwise, this is a negative result. The control line (c) is used for program control and should always appear if the test program is executed correctly.

Main Components


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

Test card: It consists of aluminum foil bag, desiccant, test paper and plastic card. The test paper consists of absorbent paper, nitrocellulose membrane, sample pad, rubber pad and rubber sheet. T line (test line) of nitrocellulose membrane was coated with 2019-nCOV Ab, C line (QC line) was coated with goat anti-mouse polyclonal antibody, and the binding pad contained labeled 2019-nCOV Ab.

Sample buffer: phosphate, sodium azide, etc.

Storage Conditions and Validity


Keep it at 2℃ to 30℃, and the provisional validity period is 18 months.

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

Production batch number: see label for details.

Expiry date: see label for details.

Sample Requirements


(1) Saliva sample collection: Do not eat or drink water, including chewing gum or using tobacco products within 30 minutes before saliva sample collection. Hold the tip of the tongue against the maxilla and collect the root of saliva. Tongue Place sterile disposable cotton swabs under the root of tongue for at least 10 seconds, immerse them completely in saliva and rotate them more than 5 times. (see figure 1)


Note: If saliva samples are not collected properly.

Figure 1 Methodsfor saliva sample collection

Figure 2 Methods for sputum sample collection

(2) Collection of sputum specimen: After rinsing with clear water, cough up sputum and put it into the specimen bag, and wipe the specimen with a disposable sterile cotton swab. (see figure 2)

(3) Sample treatment: The collected samples should be treated with the sample buffer provided by this kit as soon as possible (they should not be treated immediately, and the samples should be kept in dry, sterilized and sealed containers) and kept for inspection. 2℃ ~ 8℃ shall not exceed 24h, and -70℃ shall not exceed for a long time (but repeated freezing and thawing shall be avoided).

Test Method


Please read the instructions carefully before testing. Please return all reagents to room temperature, and the test should be carried out at room temperature.

1. Sample treatment (see Figure 3).

(1) Insert the sample swab into the sample buffer, and rotate it close to the inner wall for 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 to make the liquid flow into the tube, and take out and discard the swab.

(3) Cover with drops.

Figure 3 Sample processing

Figure 4 Test procedure

2. Test procedures (see Figure 4).

(1) take out the test card.

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

(3) Put the card at room temperature for 15 minutes to read the result, and the result is invalid after 20 minutes.

Interpretation of Test Results


Interpretation of test card (see Figure 5):

1. result: the quality control line (line c) should be re-inspected.

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

3. Positive results: Two red bands of detection line (T line) and quality control line (C line) were colored.

Figure 5 Interpretation of test results

Limitation of Test Method


1. This product is a qualitative test, which is only used to assist in in vitro diagnosis.

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

3. If there is no sputum specimen in patients, nasopharyngeal swab specimens should be used for testing.

4. Ensure to add appropriate amount of samples for testing. Too much or too little sample may lead to inaccurate results.

5. The test results of this reagent are for clinical reference only and should not be used as the only basis for clinical diagnosis and treatment. The final diagnosis of the disease should be made after 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 lowest detection limit of the kit was 6102TCID50/mL.

2. Using enterprise reference products for testing, the results should meet the requirements of enterprise reference products.

2.1 Qualified rate of positive reference materials: P1-P5 of enterprise positive reference materials are positive.

2.2 Qualified rate of negative reference materials: all the negative reference materials N1-N10 of enterprises are tested negative.

2.3 detection limit: the reference products L1-L3 and L1 are negative, and L2 and L3 are positive.

2.4 Reproducibility: J1 and J2 were tested, and they were positive 10 times each.

3. Cross-reaction: Add the following microorganisms and viruses to the samples with specified concentrations to evaluate their potential interference to the 2019-nCoV Ag detection program. 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. disruptor: Evaluate the potential interference to the test items of 2019-nCoV Ag, and add the following drugs at the indicated concentration. The results showed that all kinds of 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 inactivated culture of 2019-nCoV in the high concentration range of 1.0106 TCID50/mL.

6. Clinical research: Using RT-PCR detection reagent as contrast reagent, saliva and sputum samples were evaluated respectively. 120 positive and 120 negative samples were selected from each sample size (RT-PCR detection), and secondary detection of xiu reagent was used. The results are summarized as follows:

Precautions


1. This product is used for in vitro diagnosis.

2. This product is disposable and cannot be recycled.

3. Operate in strict accordance with the reagent instructions and read the instructions carefully before the experiment.

4. Avoid conducting experiments under severe environmental conditions (including high concentration corrosive gases such as 84 disinfectant, dust, sodium hypochlorite, acid and alkali or acetaldehyde). Laboratory disinfection should be carried out after the experiment.

5. Samples and used reagents should be regarded as potentially infectious and treated according to local laws and regulations.

6. Reagents shall be used within the validity period indicated on the outer packaging. The test card should be used as soon as possible after being taken out of 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


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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