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2019-NCoV Ag Antigen Saliva Test Kit Usage Manual Sample Requirements

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2019-NCoV Ag Antigen Saliva Test Kit Usage Manual Sample Requirements

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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 Sample Requirements

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 manifestations are fever, fatigue, dry cough, a small number of patients have 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.

Use sidestream immunoassays to legalize the detection of 2019-nCoV Ag in saliva/sputum samples of suspected patients. 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 state 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. 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

The 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, 2019 ncov Ag in the sample forms an Ag AB complex with the labeled 2019 ncov monoclonal antibody. This complex migrates upward on the membrane through 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 and should always appear 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 paper and plastic card composition. The paper consists of absorbent paper, nitrocellulose film, sample pad, rubber pad and rubber sheet. Nitrocellulose membrane T-line (test line) is packaged as 2019-NCOV Ab, c-Line (QC line) is packaged as sheep anti-rat polyclonal antibody, and 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 and drink water within 30 minutes of saliva sample collection, including chewing gum or using tobacco products.Place the tip of the tongue against the maxilla and collect the salivary roots.The tongue placed a disposable sterile cotton swab under the root of the tongue for at least 10 seconds, fully immersed in saliva and rotated more than 5 times.(see chart 1)

Note: If the 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 out the sputum and put it into the specimen bag, and wipe the specimen with a disposable sterile cotton swab.(see chart 2)

(3) Sample Treatment: collected samples shall be treated with the sample buffer provided in this kit (not treated immediately, samples shall be stored in dried, sterilized, sealed containers) for inspection.2℃ ~8℃ shall not exceed 24h and-70℃ for a long time (but repeated freeze and thaw shall be avoided).

Test Method

Please read the instructions carefully before testing. Put all reagents back to room temperature, and the test should be conducted at room temperature.

Sample treatment (see fig. 3).

(1) Insert the sample swab into the sample buffer, and rotate it close to the inner wall for about 10 times 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, 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 processed sample extract into 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 is invalid after 20 minutes.

Interpretation of Test Results

Interpretation of test card (see Figure 5):
1. Result: the quality control line (line C) shall be rechecked.
2. Negative results: quality control line (line C), red ribbon, coloring.
3. Positive results: two red bars with color on the test line (t line) and 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 has no sputum specimen, should use nasopharyngeal swab specimen 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: the inactivated sars-cov-2 virus culture was used in this study, and the minimum detection limit of the kit was 6102tcid50 / ml.
2. The enterprise reference material shall be used for testing, and the results shall meet the requirements of the enterprise reference material.
2.1 pass rate of positive control: p1-p5 of enterprise positive control is positive.
2.2 qualification rate of negative control: the enterprise'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 for 10 times.
3. Cross reaction: the following microorganisms and viruses were added to the sample at the specified concentration to evaluate their potential interference with the 2019 ncov Ag detection 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 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: No hook effect was observed in the high concentration range of 1.0106 TCID50/mL in 2019-NCOV inactivated cultures.

6. Clinical study: RT-PCR detection reagent was used as contrast reagent to evaluate saliva and sputum samples respectively. 120 positive and 120 negative samples were selected for each sample size (RT-PCR test), and a second test was performed using XIUS reagent. The results are summarized as follows:


1. This product is used for in vitro diagnosis.

2. This product is disposable and cannot be recycled.

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

4. Avoid conducting experiments under harsh 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 in 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


Batch code

Use-by date
Keep dry

Keep away from sunlight

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Basic Information


Dingluan industrial zone ,Changyuan City,453400,P.R.CHINA


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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.

Product Tags:

Ag Antigen Saliva Test Kit


2019-NCoV Antigen Saliva Test Kit


2019-NCoV saliva rapid antigen test

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