Novel Coronavirus (2019-nCoV)

Real-time RT-PCR Kit

Intended Use

Novel Coronavirus (2019-nCoV) Real-time RT-PCR Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the 2019-nCoV in oropharyngeal swabs and bronchoalveolar lavage fluid collected form individuals suspected of COVID-19 by their healthcare provider.

About SARS-CoV-2

Specific antibodies will be produced within days to weeks as the immune system makes immune defense against the SARS-CoV-2 infection. Total antibody detection is an aid in the diagnosis of patients with suspected SARS-CoV-2 infection in conjunction with clinical symptoms and result of other diagnostic methods. The test result should not be used as the sole basis for diagnosis and exclusion of SARS-CoV-2 infection. Total antibody may not be detected in the first few days of infection.

SARS-CoV-2 neutralizing antibody is a protective soluble protein secreted by adaptive immunizing cells after inoculation with SARS-CoV-2 vaccine or infection with SARS-CoV-2. These antibodies can specific bind with virus RNA binding domain (RBD) to block the binding of RBD with angiotensin-converting enzyme 2 (ACE2) on human cells surface, thus prevent the virus or its genetic material into the human cell and virus infection.

Benifits of the Kit

1) Room Temperature Transportation

2) Cost-Effective Shipping

The shipping is at room temperature, with no need of cold chain shipping.

3) Highly Sensitive, Highly Specific

Highly sensitive and highly specific for 2019-nCoV, reliable identification of COVID-19. 

4) Environmentally Friendly

The kit needs neither bulky packaging nor cold chain shipping.

Contents

A kit contains:

Package specifications: 24 tests/kit, 48 tests/kit

1) 2019-nCoV-PCR Master Mix (Lyophilized Powder): 1 bottle/box

2) 2019-nCoV-PCR Positive Control (Lyophilized Powder):1 bottle/box

3) 2019-nCoV Diluent: 1 bottle/box

4) User Manual

Note: Do not mix or interchange different batches of kits.

Specifications

Applicable Device

The kit is suitable for real-time PCR instruments with FAM, HEX (VIC/JOE), ROX channels from various manufacturers, such as ABI 7500 real-time PCR instrument.

Clinical Application

1. The kit can quickly identify whether a patient is infected with a novel coronavirus, thereby effectively controlling viral infection.

2. The test results of the kit are for clinical reference only. The clinical diagnosis and treatment of suspected cases should be considered in combination with their symptoms/signs, medical history and treatment response.