Healgen COVID-19 Rapid Tests
Features
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Detection Window (IgM): 3-5 days after incubation
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Dual band results for simple interpretation
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Multivariable analysis of immunoglobin IgG & IgM
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Room temperature storage or refrigerated (2-30⁰C / 36-86⁰F)
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Procedural internal control included
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Buffer included
Specifications
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Clinical Evaluation
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Positive Percent Agreement (PPA): IgG 96.7%; IgM 86.7%; Overall 96.7%
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Negative Percent Agreement (NPA): IgG 98.0%; IgM 99.0%; Overall 97.0%
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Clinical Agreement with Characterized Samples
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Sensitivity: IgG 96.7%; IgM 100%; Combined 100%
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Specificity: IgG 97.5%; IgM 100%; Combined 97.5%
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Specimen: Whole Blood, Serum, Plasma
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Time to Results: 10 minutes
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Shelf Life: 24 months from the date of manufacture