One Step SARS-CoV-2(COVID-19) Antigen Rapid Test (Oral Fluid) Package Insert, qualitative detection of SARS-CoV-2

Highlight:

Easy One Step Operation with High Accuracy (99.6%)

Direct collection of oral fluid on the test unit itself reduces the steps involved, such as sample collection and processing.

One Step SARS-CoV-2(COVID-19) Antigen Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens present in human oral fluid. For professional in vitro diagnostic use only.

【INTENDED USE】

The One Step SARS-COV-2 (COVID-19) Antigen Test (Oral Fluid) is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in oral fluid specimens from individuals with suspected SARS-CoV-2 infection in conjunction with clinical presentation and the results of other laboratory tests.

Results are for the detection of SARS-CoV-2 nucleocapsid protein antigens. An antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other

viruses. The agent detected may not be the definite cause of disease. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary for patient management. Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.

【DIRECTIONS FOR USE】

Allow the test device to reach room temperature (15-30°C) prior to testing. Important: Before collecting oral fluid, instruct the patients not to place anything in the mouth including food, drink, gum or tobacco products for at least 10 minutes prior to collection. Instruct the patients to deeply cough 3-5 times.

Method 1:

Remove the test device from the sealed foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch. Take off the device cap.

Place the tongue against the upper and lower jaws and roots to enrich the oral fluid. Insert the absorbent wick end into the mouth, actively swab around the gums on both sides of the mouth (10-15 times) to assist saturation.

Then put the absorbent wick under the tongue to collect oral fluid until the flow appear in the test windows (approximately 60 seconds) and then take out the device and close the device cap.

Place the test device on a flat and level surface. Then start a timer.

*NOTE: During sample collection, the hand-held part cannot be lower than the absorbent wick. Do not move the test device during testing.

Read the result at 15 minutes. Do not interpret the result after 20 minutes.

Method 2:

①Collect enough fresh oral fluid specimen (at least 0.5ml) in a single use disposable cup.

②Remove the test device from the sealed foil pouch and use it within one hour. Best results will be obtained if the test is performed immediately after opening the foil pouch. Take off the device cap.

③Place the absorbent wick into the oral fluid specimens. Keep the device up right until the flow appear in the test window (approximately 60 seconds).

④Take out the device and close the device cap. Place the test device on a flat and level surface. Then start a timer.

*NOTE: Do not move the test device during testing

⑤Read the result at 15 minutes. Do not interpret the result after 20 minutes

【INTERPRETATION OF RESULTS】

POSITIVE:* Two colored lines appear. One colored line should be in the control region (C) and another colored line should be in the Test region (T). Positive result in the test region indicates detection of SARS-CoV-2 antigens in the sample.

*NOTE: The intensity of the color in the test line region (T) will vary based on the amount of SARS-CoV-2 antigen present in the sample. So any shade of color in the test region (T) should be considered positive.

NEGATIVE: One colored line appears in the control region (C). No apparen colored line appears in the test line region (T) indicates a negative result. INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

Tag:

Place of Origin:	China
Brand Name:	ALLTEST
Certification:	CE
Model Number:	ICOV-803

Minimum Order Quantity:	N/A
Price:	negotiation
Packaging Details:	20T
Delivery Time:	2-4 Weeks
Payment Terms:	L/C, T/T
Supply Ability:	10 M tests/month

Name:	One Step SARS-CoV-2(COVID-19) Antigen Rapid Test (Oral Fluid) Package Insert, Qualitative Detection Of SARS-CoV-2	CAT No.:	ICOV-803
Specimen:	Oral Fluid	Reading Time:	15 Min
Storage Temperature:	2-30°C	Features 1:	Fast Results In 15 Minutes
Features 2:	Easy Specimen Collection	Features 3:	Simple Operation
Features 4:	No Equipment Required	Features 5:	Clear Visual Interpretation
Features 6:	High Accuracy (99.6%)
High Light:	Oral Fluid SARS-CoV-2 Antigen Rapid Test , Oral Fluid COVID-19 Antigen Rapid Test

	Hangzhou AllTest Biotech CO.,LTD
	#383, Qiaoxin Road, Xiasha Street, Qiantang Disctrict, Hangzhou, Zhejiang, P.R.China
	86-571-56267891
	selina.wu@alltests.com.cn

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