2019-nCoV Anigen Test Kit(Colloid Gold method)

Test Procedure Overview
 
 
This test procedure overview does not replace the package insert. Before you begin the test, it is important to read and follow the detailed instructions in the package insert.
The Chemdex COVID-19 Antigen Home Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection. This test is authorized for non-prescription home use with self-collected anterior nasal swab specimens directly from individuals aged 14 years and older or with adult collected anterior nasal samples directly from individuals aged 2 years or older. The Chemdex COVID-19 Antigen Home Test does not differentiate between SARS-CoV and SARS-CoV-2 Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. This antigen is generally detectable in anterior nasal flocked swabs during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Individuals who test positive should self-isolate and consult their doctor as additional testing may be necessary and for public health reporting. Negative results are presumptive, and confirmation with a molecular assay, if necessary for patient management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of an individual’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19. Individuals should provide all results obtained with this product to their doctor or healthcare provider for public health reporting. Doctors or healthcare providers will report all test results they receive from individuals who use the authorized product to relevant public health authorities in accordance with local, state, and federal requirements using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by CDC. The Chemdex COVID-19 Antigen Home Test is intended for self-use or lay user testing another in a non-laboratory setting.
 
Critical Information When & Where You Need It
The Chemdex^™ COVID-19 Antigen Home Test is all you need to determine your family’s Covid-19 status, whether symptoms are present or not. Can be used on children as young as 2 years old. Get the convenience of Chemdex!

 

Features

 

• Easy and Affordable
• Highly Accurate Nasal Swab Test
• Quick Results in 15 minutes
• Safe for children as young as 2 years old
• For use with and without symptoms

 
 
 
Frequently Asked Questions (FAQs)
 
Why must I swab both nostrils?
 
In some cases, it has been observed that only one nostril has the detectable virus. Swabbing both nostrils is important because it gives you the best chance of a collecting sufficient sample to generate an accurate result.
Who is considered high risk for severe disease?
The following people are considered high risk for severe disease:
 

• People aged 65 and older
• People in nursing homes or long-term care facilities
• People of all ages with underlying medical conditions, particularly if they are not well controlled
• Cancer
• Chronic obstructive pulmonary disease
• Chronic kidney disease
• Immunosuppressed following solid organ transplant
• Obesity (BMI >30)
• Serious heart conditions such as heart failure, coronary artery disease or cardiomyopathies
• Sickle cell disease
• Type II Diabetes

 
People may be at increased risk due to the following conditions:
 

• Asthma (moderate-severe)
• Cerebrovascular disease (affecting blood vessels to the brain)
• Cystic fibrosis
• High blood pressure
• Immunocompromised (weakened immune system) from blood or bone marrow transplants, immune deficiencies, HIV, use of corticosteroids, use of other immune weakening medications
• Neurologic conditions such as dementia
• Liver disease
• Pulmonary fibrosis
• Smoking
• Thalassemia
• Type I Diabetes

 
 
Can I injure myself using the swab?
 
The Swab is sterile and safe to use. Gently insert the entire absorbent tip of the swab (usually 1/2 to 3/4 of an inch) into your nostril (Note: With children, you may not need to insert the swab as far into the nostril.). You may experience some discomfort when swabbing your nose, but this is to be expected. Do not insert the Swab any further if you experience sharp pain.
I have a nosebleed after swabbing my nose. What should I do?
In the unlikely event your nose starts bleeding, do not insert the Swab again. Apply pressure to your nose until the bleeding stops and consult a healthcare professional.
 
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COVID-19 Solution
1. IgG/IgM Antibody Rapid Test Kit
• Novel Coronavirus (SARS-CoV-2) IgG/IgM Antibody Combined Test Kit (Colloidal Gold)
2. Antigen Rapid Test Kit
• COVID-19 Antigen Test Kit (Nasopharyngeal Swab) • COVID-19 Antigen Rapid Test Kit (Human Saliva ) • COVID-19 Antigen Test Kit (Saliva) • COVID-19 Antigen Test Kit (Nasal/Nasopharyngeal/Oropharyngeal/Saliva) • COVID-19 And Influenza A/B Antigen Test kit
3. COVID-19 Neutralizing Antibody Test Kit
• COVID-19 Neutralizing Antibody Test Kit (Immunofluorescence) • SARS-CoV-2 Neutralizing Antibody Test Kit (Colloidal Gold) • COVID-19 Neutralizing Antibody Test Kit (ELISA)
Product Information
1. Specification: 1 test/kit
① Test card: 1 pcs
② Nasal swab: 1 pcs
③ Extraction buffer: 1 bottle
④ Instruction: 1
Packing information for 1 test/kit