Healgen Scientific COVID-19 IgG/IgM Rapid Antibody Test
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Description
Our rapid antibody (serology) test from Healgen LLC looks for both IgM and IgG antibodies in a single, rapid blood test.
The presence of IgM or IgG antibodies may indicate the patient has recently been infected and/or recovered from the SARS-CoV-2 novel Coronavirus.
Our antibody tests are only available for sale to hospitals, clinics, medical centers and employers who will use the services of a licensed facility to perform their testing.
Reading and interpreting the results of a rapid antibody test requires familiarity with many factors including the rate of prevalence of infection in the local community where testing will be conducted.
Features
- Detection Window IgM: Symptomatic 3-5 days, Asymptomatic 7 days
- Sample: Test can work with whole blood, plasma and serum samples.
- Storage: The kit can be stored at room temperature or refrigerated (2-30°C).
- Shelf Life: 24 months from manufacture date
- More information, such as the product insert, clinical trial results, and CE documentation is available at request
- Forensic/Professional Use Only
- Procedural internal control included
- Tests should be conducted by a licensed phlebotomist, or a medical professional
- Verification of use case prior to shipping is mandatory
- Tests may ONLY be sold to Medium or High-Complexity CLIA laboratories (1/5/21)
Product Specifications and Resources
Time of Result | 10 minutes |
Specimen Volume | 5 mL (Serum/Plasma) ; 10 mL (Whole Blood) |
Detection Window (IgM) | Symptomatic 3-5 days, Asymptomatic 7 days |
Stability | 24 months from date of manufacture |
Storage | 2-30C |
Sensitivity | IgM 100%; IgG 96.7%; Combined 100% |
Specificity | IgM 100%; IgM 97.5%; Combined 97.5% |
Internal Control | Included |
Buffer + Pipette | Included |
25 Rapid Antibody Blood Test |