Product Description

OEM Home Lateral Flow Test Kit Room Temperature Storage

COVID-19 Testing Kits - FAQS

What is a Lateral Flow Test?

Lateral flow tests are designed to detect a live virus in people who are highly infectious, whether they are displaying symptoms or not. Their rapid turnaround time allows for mass testing in workplaces and schools without the need for expensive laboratory equipment and analysis.

How Quickly Does it Deliver a Result?

Both of our lateral flow test kits provide a visual, easy to read result in just 15 minutes, which means those who test positive can be instructed to isolate quickly and minimise exposure of COVID-19 in your school or workplace.

What is the Difference Between Antibody and Antigen Testing?

An antibody test is a blood test to determine if you’ve already been exposed to COVID-19. It works by detecting antibodies in your blood or serum.

An antigen test looks for an active COVID-19 infection such as the SARS-CoV-2 virus. If your antigen test is positive, you should self-isolate at home and follow government guidance.

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.

TEST PROCEDURE

Sample Processing:

• Take out the buffer tube, open the dripper cap.
• Gently turn the saliva collector and tighten it onto the buffer tube.
• Spit saliva into the oval mouth of the saliva collector,make the saliva flow into the tube completely until to 1000uL marker line.
• Remove the saliva collector.
• Close the dripper cup and tighten it.
• Shake the tube at least 10 times, make sure the saliva mixes well with sample buffer.
• Break the dripper head

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.

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 was established with 232 sample collected from symptomatic patients, who with symptoms onset within 7 days.

Positive results broken down by days since symptom onset:

Positive results broken down by CT value:

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. 

4. Interference Substances

The test results do not be interfered with the substance at the following concentration:

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 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