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2019-NCoV Ag Rapid Saliva / Sputum Test Usage Manual Interpretation Of Test Results

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2019-NCoV Ag Rapid Saliva / Sputum Test Usage Manual Interpretation Of Test Results

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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 Interpretation Of Test Results

Production lot number : See label for details

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 Interpretation Of Test Results

Intended Use


This kit is used for qualitative testing of the new coronavirus antigen in 2019. Collected from human saliva/sputum samples.
The new coronavirus is a new type of coronavirus that can cause viral pneumonia β. Clinical manifestations are fever, fatigue, dry cough, a small number of patients have nasal congestion, runny nose, sore throat, diarrhea and other symptoms. Severe patients usually develop breathing difficulties and/or hypoxemia after one week, and severe patients rapidly develop acute respiratory distress syndrome, infectious shock, metabolic acidosis, and clotting dysfunction.
The detection of new coronavirus antigens in saliva/sputum samples of suspicious patients was legalized by using side-flow immunoassay. Antigens are usually detected in saliva/sputum samples during the acute phase of infection. Positive results indicate the presence of viral antigens, but 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 exclude bacterial infections or infections associated with other viruses. The detected pathogen may not be the exact cause of the infection. Negative disease outcomes cannot rule out new coronavirus infections in 2019 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 whether there are clinical signs and symptoms consistent with the new coronavirus, confirmed by nucleic acid analysis if necessary.

Principle of Detection


This kit is an immunoassay reagent box based on the principle of bi-antibody sandwiching technology. As an indicator, the labeled 2019 ncov monoclonal antibodies are sprayed on the binding pad. During the testing process, the 2019 ncov Ag in the sample formed the Ag-ab complex with the labeled 2019 ncov monoclonal antibody. The compound migrates upward on the membrane through the capillary effect until it is prepackaged 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 stripes 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 tester executes correctly, the control line should always be displayed.

Main Components


The kit consists of a test card, sample buffer and swab.
Test card: by aluminum foil bag, desiccant, test paper, plastic card composition. Paper consists of absorbent paper, nitrified fiber film, sample pad, rubber pad, rubber sheet. Nitro cotton membrane T-line (detection line) packaging for 2019-NCOV Ab, c-line (QC line) packaging for goat anti-rat polyclonal antibodies, binding pad contains 2019-NCOV Ab label.
Sample buffer: phosphate, sodium azo, etc.

Storage Conditions and Validity


Temperatures remain at 2 to 30 degrees Celsius for a temporary period of 18 months.
The aluminum foil bag is valid for 1 hour after opening.
Production lot number: See label for details.
Expiration date: See label.

Sample Requirements


(1) Saliva sample collection: Do not eat or drink gum or tobacco products within 30 minutes of taking saliva samples. Place the tip of the tongue against the upper jaw and collect the saliva roots. Place the disposable sterile cotton swab under the tongue for at least 10 seconds, completely immersed in saliva, and rotate more than 5 times. (see Table 1)
Note: If saliva samples are not collected correctly.

Figure 1 Methodsfor saliva sample collection

Figure 2 Methods for sputum sample collection

(2) Sputum specimen collection: after washing with water, cough up sputum, put into the specimen bag, wipe the specimen with a disposable sterile cotton swab. (see Figure 2)
(3) Sample handling: Samples collected shall be treated with the sample buffer provided by this kit (samples not treated immediately shall be kept in dry, sterile, sealed containers) for inspection. No more than 24 hours from 2 to 8 degrees C, and a longer time of -70 degrees C (but to avoid repeated freezing and thawing).

Test Method


Read the instructions carefully before testing. Put all reagents back at room temperature and testing should be performed at room temperature.
Example 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 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 the swab and discard the swab.
(3) Cover with water droplets.

Figure 3 Sample processing

Figure 4 Test procedure

2. Testing process (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 to start the timer.
(3) The card is placed at room temperature for 15 minutes to read the results, 20 minutes after the results are invalid.

Interpretation of Test Results


Test card description (see Figure 5):
1. Result: The quality control line (C line) should be checked again.
2. Negative results: quality control line (C line), red ribbon, coloring.
3. Positive result: There are two red stripes on the test line (t line) and the quality control line (C line).

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 does not have a sputum specimen, the nasopharyngeal swab 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. After a comprehensive assessment of all clinical and laboratory results, a final diagnosis of the disease should be made.

Product Performance Indicators


1, detection limit: This study used inactivated sars-cov-2 virus culture, the minimum detection limit of the kit is 6102tcid50/ml.
2, the use of the company's standard materials for testing, test results should meet the company's standard material requirements.
2.1 Positive control pass rate: enterprise positive control p1-p5.
2.2 Negative control pass rate: Company n1-n10 negative control test is negative.
2.3 Detection limit: Refer to L1-L3, L1 is negative, L2, L3 is positive.
2.4 Reproducibility: J1 and J2 are 10 times positive.
3, cross reaction: the following microorganisms and viruses in accordance with the prescribed concentration into the sample, to assess its 2019 new coronavirus antigen detection procedures potential interference. 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: Evaluate the potential interference of the 2019-nCoV Ag detection program, and add the following drugs at the specified concentration. The results show that all kinds of drugs do not interfere with the test results of the 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 detection), 120 positive and negative samples were selected, and XIUS reagent was used for the second detection. The results of the study are summarized as follows:

Precautions


1, this product is used for in vitro diagnosis.
2, this product is a disposable product, not recyclable.
3, strictly follow the reagent instructions to operate, carefully read the instructions before the experiment.
4, avoid testing in harsh environmental conditions (including high concentrations of corrosive gases, such as 84 disinfectant, dust, sodium hypochlorite, acid base or acetaldehyde, etc.). Laboratory disinfection should be carried out after the experiment.

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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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