Diagnos COVID-19 Antigen Test Kit (Colloidal Gold)
(Cassette)

[INTENDED USE]

The COVID-19 Antigen Test Kit is used for the qualitative detection of novel coronavirus (COVID-19) antigen in human throat swab and nasal swab samples,only for in vitro diagnostic use.
The novel coronaviruses belong to the β genus. COVID-19 is an acute respi-ratory 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.
Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Rapid diagnosis of SARS-CoV-2 infection will help healthcare professionals to treat patients and control the disease more efficiently and effectively.

[PRIMARY SAMPLE COLLECTION,HANDING AND STORAGE]

 

Use the nasopharyngeal swab supplied in the kit.
1.  Nasal secretions collection
a) Carefully insert the swab into the nostril of the patient, reaching the surface of posteriornasopharynx. that presents the most secretion under visual inspection.
b) Swab over the surface of the posterior nasopharynx. Rotate the swab several times.
c) Withdraw the swab from the nasal cavity.

2.  Throat secretions collection:
a) Insert the swab completely from the mouth into the throat, centering on the red part of the throat wall and maxillary tonsils.
b) Rub the bilateral throat tonsils and throat wall moderately.
c) Avoid touching the tongue and remove the swab.

The samples should be treated with the virus sampling solution or the sample extraction solution provided with this kit as soon as possible after collection. And complete the test in 5 minutes.

[MATERIALS SUPPLIED]

 

1.One pouch contains a test cassette and a desiccant. The desiccant is for storage purposes only and is not used in the test procedures.
2.Sample extraction buffer: 1 bottle (1pc/box), 1 bottles (5pcs/box), 2 bottles (20pcs/box), 2 bottles (25pcs/box)
3. 1/5/20/25 Extraction tube(s) and dropper tip(s)
4. 1/5/20/25 Swab(s)
5. 1 Package insert.

Product Picture	Model	Product size	Introduction and specifications		PCS/CTN	CTN size	G.W/N.W
	dnsAg01	26*12*6.5cm	(2019-nCoV)New coronavirus Antigen Test (Colloidal Gold)		1000	62.5*53*30cm	14/12KGS
			Each individual test kit cassetter package inculde:
			1 color box
			1 introduction paper
			1 White base
			25 Swabs
			25Test Tubes
			25 Dropper Tips
			25 Dropper pipette
			2 bottles
			1 test cassettee+ 1 desiccant in a foil bag

[TEST PROCEDURE]

1.  Specimen extraction
a) Add 0.5mL (about 10 drops) of the sample extraction buffer into the extraction tube.
b) Insert the swab into the extraction tube which contains 0.5mL of the extraction buffer. Roll the swab at least 6 times while pressing the head against the bottom and side of the extraction tube.
c) Leave the swab in the extraction tube for 1 minute.
d) Squeeze the tube several times with fingers from outside of the tube to immerse the swab. Remove the swab. The extracted solution will be used as test sample.
e) Fit the dropper tip with filter on top of the extraction tube tightly.

2. Detection operations:
Open a pouch containing a test cassette. Place the test cassette on a dry, 
a) horizontal work surface.
b) Add 2 drops (about 60μl) of sample solution extract to the sample well of the test cassette.
c) Observe the results showed within 10-15 minutes, and the results showed after 15 minutes have no clinical significance.

[INTERPRETATION OF RESULTS]

Negative : Only a red line appears in the quality control area (C), and no line appears in the test area (T).
Positive : Two red lines appear. One is in the test area (T) and the other is in the quality control area (C).
Invalid : No red line displays in the quality control area (C). This indicates that the incorrect operation or the test cassette has deteriorated or damaged.Repeat the test with a new kit. If the problem persists, stop using this lot number immediately and contact your local supplier.
 
 
Note: Invalid samples should be treated as infectious pollutants, and samples should be collected again.

[PACKING]

 

[CONTACT US]

 
For more products inquiry , distribution and other professional service, please contact in following ways!
Address: Building 6, Electronic Information Industry Park, 2 Haiyang South Road, Chengnan Subdistrict, Rugao, Rugao, Jiangsu,226000, China.
Tel: +86 513-80116067
Fax: +86 513-85355050
Email:sales@diagnosbio.com
Web:www.diagnosbio.com