Product Selling Points

• Accurate Antigen Detection: Capable of qualitatively identifying the SARS-CoV-2 nucleocapsid protein antigen from nasal swab specimens.
• Swift and Simple: Delivers rapid outcomes through an effortless one-step testing mechanism.
• Complete Kit Components: Comprises test cards, sample extraction solution, sampling swabs, and disposable pipettes, meeting all essential needs.
• Versatile Application: Appropriate for both professional medical settings and laboratory use, facilitating COVID-19 diagnosis for suspected cases.

Detailed Product Description
The Getein Single Covid Test Kit, specifically the One Step Test for SARS-CoV-2 Antigen (Colloidal Gold), is meticulously engineered for the qualitative detection of the nucleocapsid protein antigen originating from SARS-CoV-2 within human nasal swab samples. This testing kit is primarily targeted at patients who are suspected of contracting COVID-19 as per the assessment of a healthcare provider. The novel coronaviruses fall under the β genus, and SARS-CoV-2 is responsible for triggering an acute respiratory infectious disease. Each kit is furnished with: Getein SARS-CoV-2 antigen test card (25 tests/box), securely sealed in a pouch along with desiccant. Sample extraction solution: 25 tubes per box. Sampling swab: 25 pieces per box. Disposable pipette: 25 pieces per box. User manual: 1 piece per box.

Directions for Use
Sample Collection: Employ the provided sampling swab to gather a nasal swab sample.
Sample Preparation: Insert the swab into the sample extraction solution tube and blend thoroughly.
Testing Procedure: Utilize the disposable pipette to transfer the readied sample onto the Getein SARS-CoV-2 antigen test card.
Result Interpretation: Await the designated time and scrutinize the test lines. Positive (+): Two bands emerge (one at the control area C and one at the test line T). Negative (-): A single band shows up at the control area C with no band at the test line. Invalid: No band appears at the control area C. In such a case, repeat the test with a new test card.

Materials
Test Card: Incorporates colloidal gold-labeled anti-SARS-CoV-2 antibodies, which play a crucial role in antigen detection.
Sample Extraction Solution: A buffered solution that facilitates the preparation of samples for accurate testing.
Sampling Swab: A sterile swab designed to collect nasal samples effectively.
Disposable Pipette: Used for transferring the sample solution precisely.

Product Warnings
Batch Compatibility: Do not mix or interchange different batches of kits.
Diagnostic Caution: Results should not be used as the sole determinant for diagnosis; always factor in clinical presentation and other laboratory tests.
Invalid Test Handling: Invalid tests should be repeated using a new test card. If the same situation recurs, halt the use of the batch and contact your supplier.
Manual Adherence: Follow the user manual meticulously to obtain accurate results.

Warranty Period&Shelf Life
Please refer to the product packaging for details.

Manufacturers Address

CMC Medical Devices Ltd,
Add: Office 32 19-21 Crawford Street,
London,
W1H 1PJ,
United Kingdom.