DHP Q2 Checkup 2021

COVID-19 RAPID TEST KIT CORONAVIRUS IGG / IGM RAPID TEST FDA EMERGENCY USE AUTHORIZATION (EUA) / CLIA WAIVED The COVID-19 IgG/IgM Rapid Test requires one drop of blood and 2 drops of a provided buffer solution to qualitatively detect anti-SARS-CoV-2 IgM and anti-SARS-CoV-2 IgG in human whole blood as an aid in the diagnosis of primary and second SARS-COV-2 infections. This test is certified by the FDA for point-of-care use in dental offices with staff having a high school degree or higher able to perform these tests under the direction of the dentist. This Rapid test detects two things by testing antibodies. IgG is checked to see if the individual has antibodies present from a previous infection or vaccination, and the IgM antibody is an early antibody that is created in the blood to fight a current infection and suggests that the individual is currently infected. A red line next to either of these antibodies will show presence of these antibodies in the blood.

FEATURES:

• Detection Window (IgM): Symptomatic 3-5 days, Asymptomatic 7 days • Dual band results for simple interpretation • Multivariable analysis of both IgG & IgM • Room temperature storage or refrigerated • Procedural internal control included • Buffer included • Box of 20 Tests Includes: Buffer, Pipettes, Lancets, Alcohol Swabs and IFU. • Sensitivity: IgG 90%; IgM 100% • Speci fi city: IgG 100%; IgM 98.8% • Specimen: Whole Blood, Serum, Plasma • Time to Results: 10 minutes • Shelf Life: 24 months from the date of manufacture SPECIFICATIONS:

Control Line Internal, procedural control. Changes from blue to red.

Test Region Reactive region. Detects IgG and IgM separately.

Bu ff er Well Receives bu ff er solution (included in kit). Sample Well Receives donor sample.

Antibody

Performance Measure

Estimate of Performance

95% Con fi dence Interval

IgM IgM IgG

Sensitivity (PPA) Speci fi city (NPA) Sensitivity (PPA) Speci fi city (NPA)

(30/30) 100% (79/80) 98.8% (27/30) 90.0% (80/80) 100% (30/30) 100% (79/80) 98.8%

(88.7%; 100%) (93.3%; 98.8%) (74.4%; 96.5%) (95.4%; 100%) (88.7%; 100%) (93.3%; 98.8%) (40.9%; 96%) (99.4%; 100%)

IgG

Combined Combined Combined Combined

Sensitivity Speci fi city

PPV at prevalence = 5% NPV at prevalence = 5%

80.8% 100%

Cross-reactivity

with HIV+

(0/10) 0% not detected

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*Performance results from National Institute of Health study

CLIA WAIVED/FOR PROFESSIONAL USE ONLY: These tests are available for Medical Healthcare professionals only and are NOT intended for home use. Please call for more information. Kit includes CLIA Certification!

Dual-Antibody IgG/IgM COVID-19 Rapid Test Kits 15 minute rapid finger-prick (one drop of blood) test to determine previous (IgG) and/or active infection (IgM) of COVID-19 based on antibodies detected in the blood. Kit Contains: 20 test devices, 20 assay buffer, 20 pipettes, 20 lancets, 20 alcohol wipes and instructions for use.

880-ANTIBODY20 20 tests/box............$503.25 (Only $25.16/test)

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