2019-NCoV Ag Rapid Test (Immunochromatography) Usage Manual For Self-Test Sample Requirements

Intended Use

The kit is used for qualitative detection of 2019 nCoV-Ag strains collected from human nasal swab samples.

As a new weapon, the Type 2019 NCoV is a new weapon β-Geoff. Can cause viral pneumonia, the main clinical manifestations for fever, fatigue, dry cough. A few patients with nasal congestion, runny nose, sore throat, diarrhea and other symptoms. In critically ill patients, dyspnea and/or hypoxemia usually develop after a week, and in severe cases rapidly progress to acute respiratory distress syndrome, septic shock, difficult-to-recuperate metabolic acidosis, and coagulation dysfunction.

Side flow immunoassay was used to qualitatively detect 2019 strains of nCoV-Ag in nasal swab specimens of suspected patients. During the acute phase of infection, antigens are usually detected in nasal swab samples. Positive results indicate the presence of viral antigens, but the clinical relevance of the patient's history and other diagnostic information is also necessary to determine the status of infection. A positive result does not rule out bacterial infection or co-infection with other viruses.

This kit is intended for use by the layperson in a non-laboratory environment, such as an individual's home or certain non-traditional locations, such as an office, a sporting event, an airport, a school, etc. The results of this kit are for clinical reference only. A comprehensive analysis of the condition is recommended based on the patient's clinical manifestations and other laboratory tests.

Principle of Detection

This kit is an immunoassay kit based on the principle of double antibody sandwich technology. As an indicator marker, labeled monoclonal antibody 2019 nCoV is sprayed onto the binding pad. During the test, the 2019 nCoV Ag in the sample was combined with labeled 2019 nCoV monoclonal antibody to form the Ag-Ab complex. This complex migrates up the membrane by capillary effect until it is captured by another 2019 nCoV monoclonal antibody precoated on the test line to form the sandwich complex. If there is 2019 nCoV-Ag in the sample, a red band will appear in the T-zone of the interpretation window. Otherwise, it's a negative outcome. Control line (C) is used for program control and should always be shown if the test program is executed correctly.

Main Components

The kit consists of a test card, sample buffer, and swab.
Test card: it is composed of aluminum foil bag, desiccant, test strip and plastic card. Among them, the test strip is composed of absorbent paper, nitrocellulose membrane, sample pad, binding pad and rubber sheet. Nitrocellulose membrane T line (test line) is coated with 2019 nCoV AB, C line (quality control line) is coated with goat anti-rat polyclonal AB, and binding pads are marked with 2019 nCoV AB.
Sample buffer: phosphate, sodium azide, etc

Storage Conditions and Validity

It is kept at 2℃ ~ 30℃, and its validity period is tentatively 18 months.
The validity period of the aluminum foil bag is one hour.
Batch No. : See label for details.
Expiration Period: See label for details.

Sample Requirements

(1) Nasal swab collection method: insert the sampling swab into the nostril, and the tip of the swab should be inserted 2.5cm away from the edge of the nostril. Roll the swab along the mucous membrane inside the nostril five times, then repeat the process with the same swab on the other nostril (see Figure 1)

Figure 1 Collection method for nasal swab

(2) Sample treatment: Samples collected should be processed with the sample buffer solution provided by this kit as soon as possible (if not immediately processed, they should be stored in a dry, sterilized and sealed container). They should be stored within 2 hours at no more than 24 hours at ~ 8℃, and kept at -70℃ all the time (but repeated freezing and thawing should be avoided).

Test Method

Please read the instruction carefully before the test. Return all reagents to room temperature before testing. The test should be conducted at room temperature.
1. Sample handling (see Figure 2)
1. Insert the sampling swab into the sample buffer and rotate it about 10 times near the inner wall to dissolve the sample in the solution as much as possible.
2. Squeeze the tip of the swab along the inner wall of the tube to allow as much fluid to flow into the tube as possible, remove and discard the swab.
3. Cover the emitter.

Figure 2 Sample processing

Figure 3 Detection procedure

2. Test procedure (see Figure 3)
1. Take out the test card.
2. Add 2 drops (about 80μ50) to extract the treated sample to the loading well of the test card, and then start the timer.
3. Leave at room temperature for 15 minutes before reading the results. The result was invalid after 20 minutes.

Interpretation of Test Results

Test card interpretation (Figure 4) :
① Invalid results: the quality control line (line C) is invalid without response, and should be re-tested.
② Negative results: the quality control line (line C) is red.
③ Positive results: two red bands, test line (T line) and quality control line (C line) are colored.

Figure 4 Interpretation of test results

Limitation of test method

1. This product is used for qualitative testing, only for in vitro auxiliary diagnosis.
2. This product is suitable for nasal swab samples. Results for other sample types may be inaccurate or invalid.
3. Be sure to add the right amount of samples for testing. Too much or too little sample size can lead to inaccurate results.
4. The test results of this reagent are only for clinical reference and should not be used as the sole basis for clinical diagnosis and treatment. A final diagnosis is made after a 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 minimum detection limit of the kit was 6×102TCID50/mL.

2. The company's reference products shall be used for testing, and the results shall meet the requirements of the company's reference products.

2.1 Qualification rate of positive control products: all positive control products P1-P5 of the company were positive.

2.2 Qualification rate of negative control products: all negative control products N1-N10 of the company were negative.

2.3 Detection limit: L1-L3, the lowest detection limit reference of the enterprise, L1 is negative, L2 and L3 are positive.

2.4 Reproducibility: the reference substance J1 and J2 were repeated by the testing company, and were positive for 10 times each.

3. Cross Reaction: The following concentrations of microorganisms and viruses were added to the samples at specified concentrations to assess their potential interference with the 2019 nCoV Ag test program. The results showed that there was no cross reaction and no interference from various microorganisms and viruses.

4. Intervening substances: In the 2019 nCoV-Ag test program, the following concentrations of drugs were added to the sample at the specified concentration to evaluate their potential interference. The results showed that all kinds of drugs did not interfere with the detection results of this reagent.

5. Hooking effect: In the concentration range of 1.0, no hooking effect was observed in ×106TCID50/mL and inactivated culture with 2019nCoV.
6. Clinical study: RT-PCR detection reagent was used as contrast reagent to evaluate nasal swab specimens. A total of 120 positive and 120 negative samples (RT-PCR) were selected and tested with Zhongxiu reagent. The results are summarized as follows:

Nasal swab		RT-PCR		Sum
		Positive	Negative
	Positive	116	2	118
	Negative	4	118	122
Sum		120	120	240
Sensitivity		96.67%, (95%CI: 91.74%～98.70%)
Specificity		98.33%, (95%CI: 94.13%～99.54%)

Precautions

---

1. This product is only used for in vitro diagnosis.
2. This product is a disposable product and can not be recycled.
3. Read the instructions carefully before operation, and conduct the experiment in strict accordance with the reagent instructions.
4. Avoid the experiment under harsh environmental conditions (including 84 disinfectant, sodium hypochlorite, acid and alkali or acetaldehyde and other high-concentration corrosive gas, dust and other environments). Laboratory disinfection should be carried out after the experiment.
5. All samples and reagents used should be treated as potentially infectious substances and handled in accordance with local regulations.
6. Reagents should be used within the expiry date indicated on the outer package. The test card should be used as soon as possible after it is removed from 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 devic
	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.