Novel Coronavirus 15 Min Antigen Detection Kit (Colloidal Gold)
15 Minute Novel Coronavirus Antigen Detection Kit (Colloidal Gold) - NG02 - For Professional Use Only
NewGene has created a simple and effective lateral flow test for the SARS-CoV-2 virus, which causes the COVID-19 disease. It uses a sputum or stool sample to provide you with a result in not more than 15 minutes. If you are positive this shows that you are sufficiently infected to shed the virus and thus infect other people, perhaps your parent, grand parent or other members of your family or firm. If you are negative then you are either not infected or you are infected currently at such a low level that you are unlikely to infect other people provided you observe the normal government guidance masks, hand-washing and distancing.
The clinical sensitivity of test reagent is 97.6%, the clinical specificity is 99.4%, and the total agreement rate is 98.5%.
Available in pack sizes of 5 (£64.99), 10 (£109.99) and 25 (£237.25)
Products have all CE, MHRA and BSI certifications.
COVID-19 IgM/IgG 15 Antibody Detection Kit (Colloidal Gold)
Coronavirus Spike Glycoprotein Detection Kit - For Professional Use Only
The company’s product line covers a full range of in vitro diagnostic products such as immuno diagnosis, molecular diagnosis, and microbiological testing. It has profound technical accumulation and unique technological advantages in the areas of early cancer screening, rapid detection of infectious diseases, and rapid screening of geriatric diseases.
Available in a pack size of 25 (£237.25)
COVID-19 Antibody / Antigen Detection Kit
This product is suitable for the qualitative detection of COVID-19. It provides an aid in the diagnosis of infection with novel coronavirus. For Professional Use Only
The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory 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.
Available in a pack size of 25 (£359.99)
A Coronavirus Antigen test detects the virus itself by the specific spike proteins (i.e. Antigens) on its surface, in order to identify the existence of the virus in the sample.
An Antibody test is to detect the molecules (i.e. antibodies) that people produce after being infected with the virus. Antibodies may take several days to produce after infection, and usually remain in the blood for a period after the patient recovers. There are two types, IgM Antibodies which are produced initially to fight the infection, but which disappear after several weeks and IgG Antibodies which are produced later in the cycle and which generally remain in the body much longer. Therefore, whilst the antibody test has very limited use in the diagnosis of a new COVID-19 infection is essential to indicate potential immunity. However, at present it not know how long such immunity may subsist.
FFP1 – Basic dust mask for protection against non-hazardous dust. Not suitable for protection against coronavirus.
FFF2 (equal to N95) – Filters at least 94% of airborne particles including bacteria – suitable for coronavirus protection
FFP3 (equal to N99) – Filters 99% of airborne particles – intended for protection against very fine asbestos and ceramic dust. Effective protection against coronavirus but may not be comfortable to wear for long periods of time to due reduced air flow.
An Antigen test is based on an immune reaction, whilst the nucleic acid test is based on genetic information. Therefore, an Antigen test can be much faster than the nucleic acid test (15 minutes compared with 4 hours). The cost of speed is the sensitivity. That is, an Antigen test is not as sensitive as a nucleic acid test. The nucleic acid test can detect a microscopic amount of SARS-CoV-2 virus due to its sensitivity using the amplification process of virus genetic information. This is why a PCR test takes several hours and is capable of causing aerosol contamination.
It does not require any laboratory processing and hence are suitable for large scale general screening of the population. In North America & Europe all licensed Rapid-test Antigen products are currently required to only be used by qualified professionals. However, it appears likely that Antigen tests for home use, without professional supervision, will eventually be permitted. However, if the human body contains only a very low viral load, with no obvious clinical symptoms, then an Antigen test is likely to give a negative result, thus a false negative. Helpfully, the ability of people with a low viral load to spread the virus is correspondingly lower than heavily infected patients. The Antigen test is suitable as a triaging or screening test to determine whether or not a slow but accurate nucleic acid test should be obtained. An Antigen test will be efficient in quickly identifying people with high levels of infection, those who are most likely to infect others, and distinguishing those people from others with, for example, seasonal influenza. Therefore, Antigen tests can be effective in helping to limit the spread of the pandemic, by identifying those who are most likely to spread the disease and isolating them from others.
As an Antigen test detects the virus itself sample collection is very important because the virus is only present in some areas of the body. This is different to the collection of a blood sample for an Antibody test when we may expect the Antibodies to be present throughout the patient’s venous blood, although likely to be less present in capillary blood. Accordingly, we recommend the use of a sputum sample, because sputum is a secretion from respiratory tract where the SARS-CoV-2 virus clusters the most. Hence using sputum provides a more certain method of successfully collecting a reasonable quantity of the virus in the sample, if it is present, when compared with the back of the throat nasopharyngeal sample. Because the virus is unevenly distributed on the nasopharyngeal mucosa, it is not certain that a successful sample with be obtained from this area which may lead to a false negative result. It is much more difficult and requires both expertise and some luck to obtain a truly representative sample from back of the throat. Therefore, the nasopharyngeal sample accuracy will be lower than that of sputum. Studies have shown that after people are infected, the viruses survive, and thus can be detected, in the digestive tract, especially in the intestinal stool. Therefore, if convenient (e.g. in hospital or at home), a stool sample is another option for testing; Saliva samples mixed with sputum also have a certain probability of detection, although the amount of virus contained is lower than pure sputum.
Sputum is the mucus that is coughed up from the lower airways (the trachea and bronchi). When taking a sample one should avoid its contamination / dilution with saliva so far as possible. Saliva (commonly referred to as spit) is an extracellular fluid produced and secreted by salivary glands in the mouth.
The WHO has always been a supporter of Antigen testing. Experts point out that compared with conducting an accurate test every two weeks, conducting a relatively insensitive quick test twice a week can more effectively contain the spread of SARS-CoV-2.
The reason is that it is more helpful in containing the spread of the infection where the focus is on identifying those who are likely to spread SARS-CoV-2, rather than locating anyone who is infected in any way with SARS-CoV-2 – but with a low infection much less likely to spread it.