Doctor consulting patient.

Accurate
PCR results
without the instrument

Test to treat in a single
patient visit.

Instrument-free PCR
for respiratory health

Easy to use

One swab, three targets: COVID-19, influenza A and influenza B

Affordable

No maintenance or service contracts

Scalable

Easy to run multiple test devices at the same time

Visby Medical Respiratory Health Test
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Three critical targets

COVID-19 and flu are highly contagious respiratory illnesses. The Visby Medical Respiratory Health Test can differentiate between the causative viruses and give answers to help guide providers toward the most effective treatments.

Flu A

Flu A

According to the CDC, molecular assays, including RT-PCR, are recommended for testing respiratory tract specimens from hospitalized patients because of their high sensitivity and high specificity.

Source

Flu B

Flu B

The Infectious Diseases Society of America (IDSA) recommends use of rapid influenza molecular assays over rapid influenza diagnostic tests (RIDTs) for detection of influenza viruses in respiratory specimens of outpatients.

Source

COVID-19

COVID-19

The current gold standard is to perform reverse-transcription polymerase chain reaction (PCR) on nasopharyngeal samples. Best-in-class assays demonstrate a limit of detection (LoD) of approximately 100 copies of viral RNA per milliliter of transport media.

Source

Scale
as surges
happen

The instrument free Visby Medical Respiratory Health Test allows testing for COVID-19 and flu where it’s most effective, at the point of care.

Visby Medical Respiratory Health Test

How to use the Visby Medical Respiratory Health Test

15 seconds of hands-on time. Results in less than 30 minutes.

Learn to use Visby instrument-free PCR

Product details

Visby Medical Respiratory Health Test

True PCR results that detect and differentiate RNA from the viruses that cause flu and COVID-19, in under 30 minutes with lab accuracy in the palm of your hands.

Visby Medical Respiratory Health Test face measurements
Visby Medical Respiratory Health Test profile measurements
Limit of Detection (LOD)
Influenza A
Influenza B
SARS-CoV-2
Nasopharyngeal Swab
Influenza A/HINI 2009, Brisbane/02/18
106 copies/ swab

Influenza A/H3N2, Kansas/14/2017
125 copies/ swab
Influenza B/Washington/02/19
728 copies / swab

Influenza B/Oklahoma/10/2018
778 copies / swab
SARS-CoV-2 (USA-WA1/2020)
100 copies swab
Positive Percent Agreement (PPA)
97.9%
96.9%*
97.4%
Negative Percent Agreement (NPA)
99.3%
100%*
98.8%

* Data is a combination of prospective fresh specimens (NP and AN), banked specimens (NP), and surrogate specimens (NP).

Powerful and easy
to use, anywhere

LED Status Lights

Power, progress and ready lights indicate the status of the test.

Sample Port

Add the sample and slide the purple switch to run the test.

Test Control

A clear, identifying spot that indicates test results are valid.

True PCR technology
Sample Port
Test control
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Downloads

Visby Medical developed PCR easy enough to be used by almost anyone, in any CLIA-waived setting. Below are resources to help run a successful test.

Visby Medical Respiratory Health Test

This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories. This product has been authorized only for the detection and differentiation of nucleic acid from SARS-CoV-2, influenza A, and influenza B, not for any other viruses or pathogens; and the emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.