96.67% Sensitivity COVID-19 Test Kit Lateral Flow Test Kits

2019-NCoV Ag Rapid Test (Immunochromatography) Usage Manual For Self-Test Main Components

Intended Use

The kit is used for qualitative detection of 2019-nCoV Ag collected from human nasal swab samples.
The 2019-nCOV, as a new type, is a type of nCOV. Can cause viral pneumonia, the main clinical manifestations are fever, fatigue, dry cough. A few patients are accompanied by nasal congestion, runny nose, sore throat, diarrhea and other symptoms. critically ill cases usually develop respiratory difficulties and / or hypoxemia a week later, and severe cases rapidly develop into acute respiratory distress syndrome, septic shock, difficult to correct metabolic acidosis, and coagulation dysfunction.
This product qualitatively tested suspected nasal swab samples of 2019-nCoV Ag by lateral flow immunoassay. In the acute phase of the infection, antigens are usually detected in nasal swab samples. Positive results indicated the presence of viral antigens, but the clinical relevance of patient history and other diagnostic information was also necessary to determine the determination of infection status. The positive results do not exclude bacterial infection or mixed infection with other viruses.
The kit is used at home for laymen in non-laboratory environments (such as a human home or certain non-traditional places such as offices, sporting events, airports, schools, etc.). ). The test results of this kit are for clinical reference only. It is recommended to conduct a comprehensive analysis of the condition based on the patient's clinical performance and other laboratory tests.

Principle of Detection

The kit is an immunoassay kit based on the principle of double antibody sandwich technology. The 2019 ncov monoclonal antibody marked with the marker was sprayed on the binding pad as an indicator marker. During testing, 2019 ncov-Ag in the sample was combined to the labeled 2019 ncov monoclonal antibody to form a Ag-AB complex. The complex moves upward through the capillary effect until captured by another prepacket by a 2019 ncov monoclonal antibody on the test line to form the sandwich complex. A red strip appears in the T area of the 2019 ncov-Ag, interpretation window in the sample. Otherwise, it is a negative result. The Control Line (c) is used for program control. If the test program is executed correctly, it should always be displayed.

Main Components

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

Test card: composed of aluminum foil package, desiccant, test strip and plastic card. Among them, the test paper consists of water absorption paper, cellulose nitrate film, sample pad, binding pad and rubber plate. The cellulose nitrate membrane T line (test line) package was the 2019 nCOV Ab,C line (QC line) wrapped by the goat anti-mouse polyclonal Ab, binding pad labeled 2019 nCOV Ab.

Sample buffer: phosphate, sodium nitride, etc.

Storage Conditions and Validity

Stay at 2 ℃ ~ 30 ℃, tentatively valid for 18 months.

The unpacking aluminum foil package is valid for one hour.

Production batch number: See the label for details.

Validity period: See the label for details.

Sample Requirements

(1) Nasal swab collection method: insert the sampling swab into the nostrils, and insert the swab tip at 2.5 cm from the edge of the nostrils. Roll the swab along the nostrils mucosa 5 times and then repeat the process to the other nostrils with the same swab (see Figure 1)

Figure 1 Collection method for nasal swab

(2) Sample treatment: The collected samples shall be treated as soon as possible with the sample buffer provided as this kit (if not immediately, stored in dry, sterile, sealed containers) and stored within 2 hours not more than 24 hours ℃ ~8 ℃, kept at-70 ℃ (but avoid repeated freezing and thawing)

Test Method

Read the instructions carefully before testing. Return all the reagents to room temperature before testing. The test shall be conducted at room temperature.

1. sample processing (see Figure 2)

1. inserts the sample swab into the sample buffer and rotates near the inner wall for about 10 times to dissolve the sample in the solution as much as possible.

2. squeezes the swab tip along the inner wall of the tube to flow as much liquid as possible into the tube, remove and discard the swab.

3. Cover with the drops.

Figure 2 Sample processing

Figure 3 Detection procedure

2. Test procedure (see Figure 3)

1. took out the exam card.

The 2. adds 2 drops (about 80 μ50) extracts the processed sample into the loading hole of the test card and then activates the timer.

3. read the results after 15 minutes at room temperature. Invalid results after 20 minutes.

Interpretation of Test Results

Description of the test card (Figure 4):
Invalid ① result: Quality Control Line (C Line) no response line is invalid and should be redetected.
② negative result: Quality control line (C) is red ribbon.
③ positive results: two red bands, test (T) and mass control (C).

Figure 4 Interpretation of test results

Limitation of test method

1. This product is used for qualitative testing and only for in vitro assisted diagnosis.
2. This product is suitable for nasal swab samples. Results of other sample types may be inaccurate or invalid.
3. must add an appropriate amount of samples for testing. Too much or too small the sample size can cause inaccurate results.
4. 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. The final diagnosis can only be made after a comprehensive evaluation of all clinical and laboratory results.

Product Performance Indicators

1. test limit: Using the inactivated novel coronavirus culture, the minimum test limit of the kit was 6 × 102TCID50/mL.
2. is tested using company reference products and the results shall meet Company's reference product requirements.
2.1 Qualification rate of positive quality control products: all P1-P5 positive quality control products are positive.
2.2 Qualification rate of negative control products: all negative control products N1-N10 are negative.
2.3 Detection limit: minimum detection limit reference product L1-L3, L1 negative and positive L2 and L3.
2.4 Rereproducibility: J1 and J2, 10 times per time.
3. cross-reaction: The following concentrations of microorganisms and viruses were added to the sample at a specified concentration to assess their potential interference to the 2019 nCoV Ag test program. The results show that there is no cross reaction and no interference from various microbes and viruses.

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

5. hook effect: × of 106 TCID50/ ml, 2019 nCoV inactivated culture was not observed in the high concentration range of 1.0.
6. Clinical Study: A reverse transcription-polymerase chain reaction detection reagent was used as a contrast agent to evaluate nasal swab specimens. 120 positive specimens were selected, 120 negative specimens (RT-PCR test) and tested with xiu 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

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1. This product is used for in vitro diagnosis only.
2. This product is a one-time product and cannot be recycled.
3. shall read the instructions carefully before operation and conduct the experimental operation strictly following the instructions of the reagent.
4. avoids experiments in harsh environmental conditions, including high concentrations of corrosive gases, dust, sodium hypochlorite, acid-alkali, or acetaldehyde. Laboratory disinfection shall be performed after the experiment.
All samples and reagents used by 5. shall be considered potentially infectious substances and treated in accordance with local regulations.
6. reagents shall be used within the period of validity indicated on the outer package. The test card shall be used as soon as possible after removal from the aluminum foil bag to prevent moisture.

Logo interpretation

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	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

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	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

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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.