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Product Description

Singclean Coil 19 antigen Test Kit (Colloidal Gold Method) is a solid phase immunochromatographic assay for the  rapid, qualitative detection of antigen from Coil in human nasal swab specimen. This test provides only a preliminary test result. Therefore, any reactive specimen with the coil 19 Test Kit (Colloidal Gold Method) must be confirmed with alternative testing method(s) and clinical findings.

This rapid antigen test kit is the second test kit developed by Singclean Medical for Coil 19 testing on the basis of Colloidal Gold Method after Singclean Coil 19 IgG/IgM Test Kit, an antibody test, was launched globally in March, 2020.
Coil 19 antigen test kit use Nasopharyngeal swab as sample. A nasopharyngeal swab sampling could lead to earlier and more accurate virus detection.









One Step Coil 19 Antigen Rapid Test Cassette (Nasopharyngeal Swab) 1 box(20 pieces/ box ) Composition:
20 Test Cassette
20 Antigen Extract Buffer
20 Antigen Extraction Tube
20 Swab
1 Paper workbench
1 Instruction for use

Single box of antigen test




We can also supply Coil antibody rapid test kit.

Coil 19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is an assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to coil 19 in human wholeblood, serum or plasma.
The fast test cassette, part of the kit, can detect the virus in just 10-15 minutes.
The test kit can shorten the testing time, provide easier and faster operation and make rapid diagnosis of suspected patients and on-site screening of people in close contact.


IgG/IgM Test Kit 20 pcs/box MATERIALS SUPPLIED
20 sealed pouches each containing a test cassette, a dropper and a desiccant
20 alcohol pad for disinfection use        
20 Lancet (for fingerstick whole blood only)
5 Buffer
1 package insert

STORAGE AND STABILITY FOR ANTIGEN & ANTIBODY TEST
The kit can be stored at room temperature or refrigerated (2-30°C). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
WARNINGS AND PRECAUTIONS
1. For professional In Vitro diagnostic use only. Do not use after expiration date.
2. This package insert must be read completely before performing the test. Failure to follow the insert gives inaccurate test results.
3. Do not use it if the tube/pouch is damaged or broken.
4. Test is for single use only. Do not re-use under any circumstances.
5. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing and follow the standard procedures for proper disposal of specimens.
6. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
7. Humidity and temperature can adversely affect results.
8. Do not perform the test in a room with strong air flow, ie. electric fan or strong air-conditioning.

Company Information
Hangzhou Singclean Medical Products Co., Ltd., established in 2003 with registered capital of RMB 80 million Yuan, is a national high and new technology enterprise. Singclean Medical manufacturing site covers the construction area of 17,000 m2, including producing tract 13,200 m2, class C cleanroom 2,300 m2, class B cleanroom 300 m2, class A cleanroom 60 m2.
Our main products include Cross-linked Sodium Hyaluronate GEL, Medical Sodium Hyaluronate Products, High-tech Hemostatic Products, and In-vitro Diagnostic Reagents Products.
Singclean has fully established and strictly operated the quality management system for In-vitro Diagnostic Reagents Products, to ensure the company has the capability to