Product Description

2019 nCoV Ag Saliva Rapid Test Cup

Description

You can perform this "lollipop test" yourself at home, at work, at school, in fact anywhere. Just put it in your mouth, then snap it into the case and you'll know the result in 15 minutes. It became an absolute hit in Austria and is finally available in the Czech Republic.

Fast and gentle test for qualitative detection of SARS-CoV-2 nucleocapsid protein antigen. It is intended for use when COVID-19 is suspected, within the first 7 days of the onset of symptoms. The V-Chek Rapid Test 2019-nCoV Ag Saliva Card is non-invasive and comfortable. It is performed from a saliva sample taken only by inserting a tampon into the mouth. This gentle method makes testing accessible to children, people who have difficulty taking nasopharyngeal sampling, or patients with cognitive impairments. Using the test is very simple. The swab is inserted directly into the test card, so no test tube is needed to perform the test. You will get the result in 15 minutes. The test card is intended for both professional use and for home testing or testing in companies *.

PRINCIPLE OF THE TEST

This test uses double-antibody sandwich to legally detect the antigen of novel coronavirus (2019-nCoV) in saliva samples. During detection, the gold labeled anti-2019-nCoV monoclonal antibody in the labeling pad binds to the 2019-nCoV antigen in the sample to form a complex, and the reaction complex moves forward along the nitrocellulose membrane under the action of chromatography, it is captured by the anti-2019-nCoV monoclonal antibody pre-coated by the detection zone (T) on the nitrocellulose membrane, and finally a red color reaction line is formed in the T zone. If the sample does not contain 2019-nCoV antigen, a red color reaction line cannot be formed in the T zone. Regardless of whether the sample to be tested contains 2019-nCoV antigen, a red reaction line will always form in the quality control area (C).

MATERIALS AND COMPONENTS

Materials provided with the test

Materials required but not provided

• Timer

STORAGE AND STABILITY

• Store the test as packaged between 2-30°C.
• The Test stable until the expiration date printed on the outer packing, the product will be expired after 24 months.
• Do not use beyond the expiration date.
• Do not freeze any contents of the test
• The test must remain in the sealed pouch until use.

SAMPLE REQUIREMENTS

• Insert the sponge end of the saliva swab into mouth. Actively swab the inside of the mouth and tongue to collect oral fluid for 3 minutes.
• Remove the saliva swab from the mouth when the sponge become fully saturated and the inductor turn red.
• Do not eat or drink any things for 4 hours before the test
• The samples should be used as soon as possible after collected.
• Samples should not be inactivated.

TEST PROCEDURE

Before test, please read the instructions carefully.

• Take the Test Cup to equilibrate to room temperature.
• Unpack the aluminum foil bag, place the Test Cup horizontally on the table and mark it.
• Insert the saliva swab into the Test Cup and screw the cap.
• Tighten the lid and start the timer.
• As the test begins to work, the purple color move across the result window in the center of the test device.
• Wait for 15 minutes and read the results. Do not read results after 20 minutes.

INTERPRETATION OF TEST RESULTS

This product can only perform qualitative analysis on the detection object.

Positive Result:

If both C and T lines are visible within 15 minutes, the test result is positive and valid.

Note: Specimens containing very low levels of target antibodies may develop two colored lines over 15 minutes.

Negative Result:

If test area (T line) has no color and the control area displays a colored line, the result is negative and valid

Invalid Result:

The test result is invalid if a colored line does not form in the control region. The sample must be re-tested, using a new Test Cup.

LIMITATIONS

• The result of the Test Cup should not be taken as a confirmed diagnosis, for clinical reference only. Judgement should be made along with RT-PCR results, clinical symptoms, epidemiological information and further clinical data.

2. Limit of Detection

The experimental results show that for the virus culture concentration above 100 TCID50/mL, the positive rate of detection is greater than or equal to 95%. For the virus culture concentration of 50 TCID50/mL and below, the positive rate of detection is lower than 95%. So, the limit of detection of the Test Card is 100 TCID50/mL.

3. Cross-reactivity

Cross-reactivity of the test card was evaluated. The results showed no cross reactivity with the following specimen.

1. Precision

1. Test 10 replicates of negative and positive by using the reference materials of enterprises. The negative agreement and the positive agreement were 100%.

2. Test three different lots kits including positive and negative reference materials of enterprises. The negative results and the positive results were 100%

2. Hook Effect

The Test Cup was tested up to 1.6 × 10⁵ TCID₅₀/ml of heat-inactivated 2019-nCoV strain and no high-dose effect was observed.

PRECAUTIONS

• For in vitro diagnostic use.
• Use appropriate precautions in the collection, handling, storage, and disposal of patient samples and used test contents.

Use of Nitrile, Latex (or equivalent) gloves is recommended when handling patient samples.

• Do not reuse the used Test Cup or saliva swab.
• Should never open the foil pouch of the Test Cup exposing it to the ambient environment until the Test Cup is ready for immediate use.
• Discard and do not use any damaged or dropped Test Cup or material.
• Inadequate or inappropriate sample collection, storage, and transport may yield false test results.
• Sample collection and handling procedures require specific training and guidance.
• To obtain accurate results, do not use visually bloody or overly viscous samples.
• To obtain accurate results, an opened and exposed Test Cup should not be used.
• Testing should be performed in an area with adequate ventilation.
• Wear suitable protective clothing, gloves, and eye/face protection when handling the contents of this test.
• Wash hands thoroughly after handling.

KEY TO SYMBOLS USED

		Materials Included			Test Cassette
		Instructions for Use			Date of
					Manufacturer
		Consult Instructions			Do Not Reuse
		For Use
		Store at 2°C~30°C			Catalogue Number
		Expiration Date			Keep away from Sunlight
		Manufacturer			Tests per Kit
		Lot Number			In Vitro Diagnostic Medical Device
		Keep Dry
		Guangzhou Decheng Biotechnology Co., LTD
		Room 218, Building 2, No.68, Nanxiang Road, Science City, Huangpu District, 510000, Guangzhou P.R.China
		TEL:+86-020-82557192
		sales@dochekbio.com
		www.dochekbio.com
	CMC Medical Devices & Drugs S.L.
	C/ Horacio Lengo Nº 18, CP 29006,
	Málaga, Spain