Product Description

Corona Saliva Antigen Test Kit High Accurate For Diagnostic Use

Description

If you don’t like the idea of nasal or throat swabs tests, our new highly accurate Saliva tests could be the answer.

These lateral flow tests are accurate, fast, and comfortable to use, and more importantly, it eliminates the close contact with the examiners, reducing the risk of viral exposure.”

Our New COVID-19 Antigen test from dispenses with the unpleasant and sometimes painful nasopharyngeal swabs and can provide evidence of a possible COVID-19 outbreak within the office comfortably within 10minutes with only a little saliva with a gold standard specificity of 100% and a remarkable sensitivity of 94%.

Each Coronavirus Ag Colloidal Gold Saliva Lateral Flow Test includes all necessary reagents and requires no additional specialist equipment to conduct a successful COVID-19 test in only 10 minutes, this makes the test ideally suited for workplace testing schemes.

SUMMARY AND EXPLANATION

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

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

Test Procedure

Before test, please read the instruction manual.

• Take the sample buffer and test cassette to equilibrate to room temperature.
• Unpack the aluminum foil bag, place the test cassette horizontally on the table and mark it.
• Add 80μL (3 drops) of the processed sample to the sample well, and timed. Recommended to use a pipette to take buffer/samples to reduce deviations.
• As the test begins to work, the purple color move across the result window in the center of the test device.
• Wait for 10 minutes and read the results.

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 10 minutes, the test result is positive and valid.

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 Kit.

LIMITATIONS

• The result of the Test Kit 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.

• Test Kit performance depends on the amount of virus (antigen) in the sample and may or may not correlate with viral culture results performed on the same sample.
• The Test Kit must be equilibrated to room temperature (18℃~26℃) before used, otherwise the results may be incorrect
• A negative test result may occur if the level of antigen in a sample is below the detection limit of the test.
• Failure to follow the Test Procedure may adversely affect test performance and/or invalidate the test result.
• React less than 10 minutes may lead a false negative result; React more than 10 minutes may lead a false positive result.
• Positive test results do not rule out co-infections with other pathogens.
• Negative test results are not intended to rule in other viral or bacterial infections.
• Negative results should be treated as presumptive and confirmed with a molecular assay.
• Clinical performance was evaluated with fresh samples.
• Users should test specimens as quickly as possible after specimen collection.

PERFORMANCE CHARACTERISTIC

1. Clinical Verification

The performance of Test Kit was established with 242 sample collected from symptomatic patients, who with symptoms onset within 7 days.

Sensitivity: 95.04% (115/121), 95% CI (89.60,97.71)

Specificity: 98.54% (135/137), 95% CI (94.83, 99.60).

The performance of Test Kit with positive results stratified by the comparative method cycle threshold (Ct) counts were collected and assessed to better understand the correlation of assay performance to the cycle threshold, As presented in the table below, the positive agreement of the Test Kit is higher with samples of a Ct count <25.

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 Kit is 100 TCID₅₀/mL

• Cross-reactivity

5. 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%

6. Hook Effect

The Test Kit 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 kit or saliva collector.
• Should never open the foil pouch of the Test Kit exposing it to the ambient environment until the Test Kit is ready for immediate use.
• Discard and do not use any damaged or dropped Test Kit 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 Kit 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 Card
		Instructions for Use			Saliva Collector
		Consult Instructions For Use			Date of Manufacturer
		Store at 2°C~30°C			Do Not Reuse
		Expiration Date			Catalogue Number
		Manufacturer			Keep away from Sunlight
		Lot Number			Tests per Kit
		Keep Dry			In Vitro Diagnostic Medical Device
		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

Doc No.: DC-IN-0619C01 Ver 1.3

Rel.:2021/01/31