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COVID-19 Ag Rapid Test Antigen Saliva Rapid Sputum Test Manual Storage Conditions

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COVID-19 Ag Rapid Test Antigen Saliva Rapid Sputum Test Manual Storage Conditions

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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 Storage Conditions And Validity

Intended Use


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

2019-nCOV is a new type of β-COV that can cause viral pneumonia. Clinical performance is mainly fever, fatigue, dry cough, a small number of patients with nasal congestion, runny nose, sore throat, diarrhea and other symptoms. Severe cases often develop breathing difficulties and/or hypoxemia after one week, and severe cases develop rapidly into acute respiratory distress syndrome, infectious shock, metabolic acidosis and clotting dysfunction.

Qualitatively detect 2019-nCoV Ag in saliva/sputum samples of suspected patients with lateral flow immunoassay. Antigens are usually detected in saliva/sputum samples during the acute phase of infection. Positive results show the presence of viral antigens, but the clinical correlation between the patient's medical history and other diagnostic information is also necessary to determine the status of infection. Positive results do not rule out bacterial infection or co-infection with other viruses. The detected pathogen may not be the exact cause of the infection. disease. Negative results cannot rule out 2019-nCoV infection and should not be used as a basis for treatment or patient management decisions, including infection control decisions. If the results are negative, a final decision should be made based on the patient's recent exposure history, medical history, and the presence of clinical signs and symptoms consistent with 2019-nCoV, as confirmed by nucleic acid analysis if necessary.

Principle of Detection


This kit is an immunoassay based on the principle of biant antibody sandwiching technology. As an indicator, the labeled 2019-nCoV monoclonal antibodies are sprayed on the binding pad. During the test, the 2019-nCoV Ag in the sample formed the Ag-Ab complex with the labeled 2019-nCoV monoclonal antibody. This complex migrates upward on the membrane through the capillary effect until it is pre-packaged on the test line and captured by another 2019-nCoV monoclonal antibody to form a sandwich complex. If 2019-nCoV Ag is present in the sample, a red stripe 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 executes correctly.

Main Components


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

Test card: Consists of aluminum foil bag, desiccant, test paper and plastic card. The paper is composed of absorbent paper, nitrified fiber film, sample pad, rubber pad and rubber sheet. The cellulose nitrate membrane T-line (detection line) package is 2019-nCOV Ab, C-line (QC line) package is sheep anti-rat polyclonal antibodies, binding pad contains labeled 2019-nCOV Ab.

Sample buffer: phosphate, sodium azo, etc.

Storage Conditions and Validity


It is maintained from 2 to 30 degrees C and is tentatively valid for 18 months.

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

Production lot number: See label for details.

Expiration 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 of saliva sample collection. Place the tip of the tongue against the upper jaw and collect the saliva roots. Tongue Place a disposable sterile cotton swab under the root of the tongue for at least 10 seconds, completely immerse it in saliva and rotate it 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) Sputum specimen collection: after rinsing with water, coughing up sputum into the specimen bag, wipe the specimen with a disposable sterile cotton swab. (see Figure 2)

(3) Sample handling: The collected sample should be treated with the sample buffer provided by this kit as soon as possible (should not be treated immediately, the sample should be kept in a dry, sterilized, sealed container) and left for inspection. No more than 24h at 2C to 8C and no more than -70C in the long term (but repeated freezing and thawing should be avoided).

Test Method


Read the instructions carefully before testing. Put all reagents back at room temperature and the test should be conducted at room temperature.

Sample handling (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 dissolves as much as possible in the solution.

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

(3) Cover with drops.

Figure 3 Sample processing

Figure 4 Test procedure

2. Test the program (see Figure 4).

(1) Remove the test card.

(2) Add 2 drops (about 80L) of processed sample extract to the sample hole of the test card and start the timer.

(3) Put the card at room temperature for 15 minutes to read the results, 20 minutes after the results are invalid.

Interpretation of Test Results


Test card interpretation (see Figure 5):

1. Result: The quality control line (c line) should be re-examined.

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

3. Positive results: detection line (T line) and quality control line (C line) two red bars with color.

Figure 5 Interpretation of test results

Limitation of Test Method


1, this product is a qualitative test, only for auxiliary in vitro diagnosis.

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

3. If the patient has no sputum specimen, the nasopharyngeal swab specimen should be used for testing.

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

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

Product Performance Indicators


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

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

2.1 Positive control pass rate: Enterprise-positive control P1-P5 is positive.

2.2 Negative control pass rate: Enterprise N1-N10 negative control tested negative.

2.3 Detection limit: Reference L1-L3, L1 is negative, L2, L3 is positive.

2.4 Reproducibility: J1 and J2 have tested positive 10 times.

3. Cross-reaction: Add the following microorganisms and viruses to the sample at the specified concentration to assess their potential interference with the 2019-nCoV Ag testing procedure. virus.

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. Interference: Assess potential interference with the 2019-nCoV Ag testing program and add the following drugs at the indicated concentration. The results showed that all kinds of drugs did not interfere with the test 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 high concentration range of 1.0106 TCID50/mL for 2019-nCoV inactivated cultures.

6, clinical research: RT-PCR test reagents as a comparative reagent, respectively, saliva and sputum samples were evaluated. 120 positive and 120 negative samples (RT-PCR tests) were selected for each sample size, and a secondary test was performed using the xius reagent. The results are summarized as follows:

Precautions


1, this product is used for in vitro diagnosis.

2. This product is a disposable product and is not recyclable.

3, strictly follow the reagent instructions operation, carefully read the instructions before the experiment.

4, avoid in harsh environmental conditions (including 84 disinfectant liquid, dust, sodium hypochlorite, acid base or acetaldehyde and other high concentrations of corrosive gases) to carry out experiments. Laboratory disinfection should be carried out after the experiment.

5. Samples and used reagents should be considered potentially contagious and treated in accordance with local laws and regulations.

6, reagents should be used during the validity period indicated in the outer packaging. The test card should be used as soon as possible after removal from the 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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