Healgen COVID 19 Antibody Test Instruction Video 03:00
Healgen COVID ...In this video we break down the step by step process of Healge...
COVID-19 ANTIBODY RAPID DETECTION KIT 402A
Healgen -COVID-19 IgG/IgM Rapid Test Cassette 25 Tests/Kit (Whole Blood/Serum/Plasma
Emergency Use Authorization (EUA) from the US FDA.
The COVID-19 IgG/IgM (Whole Blood/Serum/Plasma) Rapid Test Device utilizes lateral flow technology that is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general, antibodies can be detected 1-3 weeks after infection. This test is intended to screen patients for COVID-19. Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals.
Coronaviruses are enveloped RNA viruses that are distributed broadly among humans, other mammals and birds that cause respiratory, enteric, hepatic and neurologic diseases. Four viruses - 229E, OC43, NL63 and HKU1 are prevalent and typically cause common cold symptoms in immunocompromised individuals. Three other strains SARS-CoV, MERS-CoV and SARS-CoV-2 (COVID-19) are can be transmitted from between non-human vertebrates to humans.
Detection Window (IgM): 3-5 days after incubation
Dual band results for simple interpretation
Multivariable analysis of immunoglobin IgG & IgM
Room temperature storage or refrigerated (2-30⁰C / 36-86⁰F)
Procedural internal control included
Tests should only be conducted by a medical professional.
**Due to FDA Guidelines and Supply Chain Demands All Coronaviruses COVID-19 Related Orders and/or Products are NON-Cancellable and NON-Returnable.**
Printable PDF Support Documents
|FDA EUA Healgen Rapid Tests||Clinical Evaluation Report||Material Safety Data Sheets (SDS)|
|Healgen 402A Package Insert||Fact Sheet for Healthcare Providers||Fact Sheet for Recipients|
More Product Information
Positive Percent Agreement (PPA): IgG 96.7%; IgM 86.7%; Overall 96.7%
Negative Percent Agreement (NPA): IgG 98.0%; IgM 99.0%; Overall 97.0%
Clinical Agreement with Characterized Samples
Sensitivity: IgG 96.7%; IgM 100%; Combined 100%
Specificity: IgG 97.5%; IgM 100%; Combined 97.5%
Specimen: Whole Blood, Serum, Plasma
Time to Results: 10 minutes
Shelf Life: 24 months from the date of manufacture
Instructions for Use:
1. Remove the test cassette from the sealed foil pouch and use it as soon as possible.
2. Lay device on flat surface and add specimen (see specific instructions for each specimen type below):
a. For Serum or Plasma Specimen: With the plastic dropper provided, draw serum/plasma specimen to exceed the specimen line, as shown in the diagram below. Hold the dropper vertically and transfer drawn serum/plasma specimen into the sample well (S). Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well (B) ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.
b. For Whole Blood Specimen: Hold the plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the sample well (S) of the test device. Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well (B) ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.
3. Wait for the control line (C) to change from blue to a red color. If, after 2 minutes, the sample has not moved across the test window or if blood is still present in the sample well (S), add 1 additional drop of sample buffer to the buffer well (B).
4. The results should be read in 10 minutes. Do not interpret the result after 15 minutes.
PLEASE NOTE: Information above in this section might be an overall summary about the product line and not in regards to the specific product. If you have any questions, Please E-mail or Call 1-877-WILBURN (1-877-945-2876).
PLEASE NOTE: Images, Descriptions, and Titles may not accurately represent the product. You are encouraged to confirm that the manufacturer item code above matches the products you are seeking. All patients or home users should have a valid prescription for any medical supplies or devices that require one. Some of our products have special shipping requirements due to weight and refrigeration; please visit our Shipping Page for Details. All products on this website are subject to current manufacturer pricing changes and availability. If you are uncertain or have questions, Please E-mail or Call us at 1-877-WILBURN (1-877-945-2876) for additional information.
Thank you in advance for your business,
The Wilburn Medical Team
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