BELTEST-IT COV-2

The BELTEST-IT COV-2 Rapid Test is an in-vitro diagnostic test for the qualitative detection of IgG and IgM antibodies to the SARS-CoV-2 virus in human serum and whole blood (venipuncture and/or fingerstick) samples collected in CLIA certified laboratories and/or by healthcare professionals at the point-of-care.

It provides healthcare professionals with a fast, convenient, and qualitative aid in the diagnosis of SARS-CoV-2 infection.*

PRODUCT INFORMATION

MethodImmunochromatographic assay
Specimen TypeHuman whole blood (venipuncture and/or fingerstick) or serum
Specimen Sizemax. 50 μL
Time to Results20 minutes
Storage Conditions2°C to 30°C (35°F to 86°F)
Shelf Life12 months

KIT CONTENTS

  • Test cassette

  • Pipette for transferring blood from the fingertip to the test cassette

  • Desiccant packet

  • Lancet

  • Vial containing buffer solution

  • Plastic bag for disposal of used test materials

  • Pouch with label

  • Instructions for use

BELTEST-IT COV-2: Instructional Video

TEST PERFORMANCE

As of June 20, 2020; a total of 1,809 tests were carried out for validation, with 643 measurements evaluated to determine the test sensitivity and 1,166 for specificity.

SENSITIVITY

IgM 98.1%
IgG 98.2%

SPECIFICITY

IgM 99.5%
IgG 99.7%

ACCURACY

IgM 99.0%
IgG 99.2%

CROSS REACTIVITY

Pharmact tested serum samples from five HCV patients, five ANA patients, five RSV (respiratory syncytial virus) patients and six influenza (no fever) patients. All results were negative, suggesting that infection with these four diseases does not affect the specificity of the test.

*NOTE: Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in recent contact with the virus. Follow-up testing with an accepted reference method (e.g., RT PCR) should be considered to rule out infection in these individuals. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. As with all diagnostic assays, the results obtained with this test must only be used as an adjunct to other information available to the healthcare professional. Treatment of patients should be based on a combination of symptoms, clinical signs, medical history, other laboratory tests and therapeutic responses.