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2019-NCoV Saliva Sputum Ag Rapid Test Kit Usage Manual Test Method

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2019-NCoV Saliva Sputum Ag Rapid Test Kit Usage Manual Test Method

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Brand Name : ZOSBIO

Model Number : 2019-NCoV Neutralizing Antibody

Certification : CE BfArm

Place of Origin : Henan

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 Test Method

Intended Use


This kit is used for the qualitative test of 2019 nCoV Ag. Collected from human saliva/sputum samples.
2019 nCOV is a new type of β-COV that can cause viral pneumonia. The clinical manifestations are fever, fatigue, dry cough, and a few patients have symptoms such as nasal congestion, runny nose, sore throat, and diarrhea. Severe patients usually develop dyspnea and/or hypoxemia after a week, and severe patients rapidly develop acute respiratory distress syndrome, septic shock, metabolic acidosis, and coagulopathy.
Use lateral flow immunoassay to legalize the detection of 2019 nCoV Ag in saliva/sputum samples of suspicious patients. During the acute phase of infection, antigens are usually detected in saliva/sputum samples. A positive result indicates 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 infection status. A positive result does not exclude bacterial infections or infections related to other viruses. The detected pathogen may not be the exact cause of the infection. Negative disease results cannot exclude 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 based on the patient's recent contact history, medical history, and whether there are clinical signs and symptoms consistent with 2019 nCoV (if necessary, it can be confirmed by nucleic acid analysis).

Principle of Detection


This kit is an immunoassay kit based on the principle of double antibody sandwich technology. As an indicator, the labeled 2019 ncov monoclonal antibody was sprayed on the binding pad. During the test, the 2019 ncov Ag in the sample and the labeled 2019 ncov monoclonal antibody formed an Ag-AB complex. The 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, red streaks will appear in the T area of the window. Otherwise, this is a negative result. The control line (c) is used for program control. If the test program is executed correctly, the control line should always appear.

Main Components


The kit consists of a test card, sample buffer and swab.
Test card: It is composed of aluminum foil bag, desiccant, test paper and plastic card. The paper consists of absorbent paper, nitrocellulose membrane, sample pad, rubber pad and rubber sheet. The nitrocellulose membrane T line (test line) is packaged as 2019-NCOV Ab, the c line (QC line) is packaged as goat anti-mouse polyclonal antibody, and the binding pad contains the label 2019-NCOV Ab.
Sample buffer: phosphate, sodium azide, etc.

Storage Conditions and Validity


The temperature is maintained at 2 to 30 degrees Celsius, and the temporary validity period is 18 months.
The aluminum foil bag is effective within one hour after opening.
Production batch number: see label for details.
Validity period: see label for details.

Sample Requirements


(1) Saliva sample collection: Do not eat or drink within 30 minutes after saliva sample collection, including chewing gum or using tobacco products. Place the tip of the tongue against the upper jaw and collect the saliva roots. Put the disposable sterile cotton swab under the tongue for at least 10 seconds with the tongue, soak it completely in the saliva, and rotate it more than 5 times. (See Table 1)
Note: If the saliva sample is not collected properly.

Figure 1 Methodsfor saliva sample collection

Figure 2 Methods for sputum sample collection

(2) Sputum specimen collection: After washing with water, expectorate the sputum, put it into the specimen bag, and wipe the specimen with a disposable sterile cotton swab. (See Figure 2)
(3) Sample processing: The collected samples should be processed using the sample buffer provided by this kit (not processed immediately, the samples should be stored in a dry, sterilized, sealed container) for inspection. 2℃~8℃ shall not exceed 24 hours and -70℃ for a longer time (but avoid repeated freezing and thawing).

Test Method


Please read the instructions carefully before testing. Return all reagents to room temperature, and the test should be carried out at room temperature.
Sample processing (see Figure 3).
(1) Insert the sample swab into the sample buffer and rotate it about 10 times close to the inner wall to make the sample dissolve 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, remove and discard the swab.
(3) Cover with water droplets.

Figure 3 Sample processing

Figure 4 Test procedure

2. Test procedure (see Figure 4).
(1) Take out the test card.
(2) Add 2 drops (about 80L) of the 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 result, and the result will be invalid after 20 minutes.

Interpretation of Test Results


Explanation of the test card (see Figure 5):
1. Result: The quality control line (line C) should be re-checked.
2. Negative results: quality control line (line C), red ribbon, coloring.
3. Positive result: There are two red strip colors on the test line (line t) and the quality control line (line C).

Figure 5 Interpretation of test results

Limitation of Test Method


1. This product is a qualitative test 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. If the patient does not have a sputum sample, a nasopharyngeal swab should be used for testing.
4. Make sure to add the right amount of sample for testing. Too many or too few samples may 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. After a comprehensive evaluation of all clinical and laboratory results, the final diagnosis of the disease should be made.

Product Performance Indicators


1. Detection limit: This study uses inactivated sars-cov-2 virus culture, and the minimum detection limit of the kit is 6102tcid50/ml.
2. Use corporate standard materials for testing, and the test results should meet the requirements of corporate standard materials.
2.1 Pass rate of positive control: The enterprise is positively controlling p1-p5.
2.2 Negative control qualification rate: the company's n1-n10 negative control test is negative.
2.3 Detection limit: Refer to L1-L3, L1 is negative, L2 and L3 are positive.
2.4 Reproducibility: J1 and J2 were positive 10 times.
3. Cross-reaction: The following microorganisms and viruses are added to the sample at the specified concentration to evaluate their potential interference with the 2019 ncov Ag detection program. 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 procedure and add the following medications at the indicated concentration. The results showed that all kinds of drugs did not interfere with the test results of reagents.

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: In the 2019-NCOV inactivated culture, no hook effect was observed in the high concentration range of 1.0106 TCID50/mL.
6. Clinical research: RT-PCR detection reagents are used as contrast reagents to detect saliva and sputum samples respectively. For each sample size (RT-PCR test), select 120 positive and 120 negative samples, and use XIUS reagent for the second test. The results are summarized as follows:

Precautions


1. This product is used for in vitro diagnosis.
2. This product is a disposable product and cannot be recycled.
3. Strictly follow the instructions of the reagents, and read the instructions carefully before the experiment.
4. Avoid testing under harsh environmental conditions (including high-concentration corrosive gases, such as 84 disinfectant, dust, sodium hypochlorite, acid-base or acetaldehyde). Laboratory disinfection should be carried out after the experiment.
5. The samples and reagents used should be considered as potentially infectious and handled in accordance with local laws and regulations.
6. The reagent should 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

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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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