Answers to some frequently asked questions.
Sexual Health Test
What is the Visby Medical Sexual Health Click Test?
The Visby Medical Sexual Health Click Test is a single-use, fully-integrated, rapid, automated polymerase chain reaction (PCR) in-vitro diagnostic test for the qualitative detection and differentiation of DNA from Chlamydia, Gonorrhea, Trichomoniasis infections.
What type of test is the Visby Medical Sexual Health Click Test?
The Visby Medical Sexual Health Click Test is a single-use (disposable), fully-integrated, automated Polymerase Chain Reaction (PCR) in vitro diagnostic test intended for use in point-of-care or clinical laboratory settings for the rapid detection and differentiation of DNA from Chlamydia trachomatis(CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis(TV) in self-collected female vaginal swab specimens collected in Visby Medical Collection Media in a health care setting. The test results are to aid in the diagnosis of symptomatic or asymptomatic infections with CT, NG, and TV.
Who can use the Visby Medical Sexual Health Click Test?
The Visby Medical Sexual Health Click Test is intended for use with vaginal samples from women, aged 14 years of age or older.
When will the Sexual Health Click Test be available?
The Visby Medical Sexual Health Click Test will begin shipping in the late summer of 2021.
Will I need a prescription to use this test?
Yes, the Visby Sexual Health Click Test will only be available in CLIA-waived point-of-care settings with a prescription, such as a clinician’s office.
What does the FDA clearance mean for Visby and for the use of the Visby Medical Sexual Health Click Test?
- There remains a need for diagnosis prior to treatment – treatment for STIs is, currently, usually conducted without a timely diagnostic result present, resulting in over or under treatment, the need for further clinic visits, additional treatments, and elongation of the infection itself.
- Typically, on-site testing takes 24-48 hours and send-out testing takes 6-13 days, forcing women to wait for a diagnosis, clinicians to prescribe blindly, relying mainly on empirical experience without data, causing stress and anxiety for both patients and clinicians.
- Visby Medical delivers innovation that makes PCR fast, accessible, affordable, and simple: Immediacy to test within ~30 minutes and helps to ensure appropriate treatment during a single patient visit, and freedom from instrument commitment and maintenance.
- The clearance by the FDA for the Visby Medical Sexual Health Click Test validates Visby Medical’s PCR technology as a comparable option for clinicians to test and help diagnose infectious diseases, and provides a tool to enable clinicians to test first and appropriately treat thereafter.
Why the focus on women’s health specifically?
- Women are disproportionately impacted by these infections – they are more likely to experience symptoms, have serious long-term health issues if left untreated, and the infections can cause future fertility and maternity impairment.
- According to the CDC: in 2018, new infections totaled nearly $16 billion in direct lifetime medical costs, and women face a disproportionate burden in terms of severe health outcomes and medical costs2.
- The CDC reported an estimated 68 Million active STIs in 2018, and 26 Million new STIs; which included1
- 6.9 million new in trichomoniasis infections
- 4 million new chlamydia infections
- 1.6 million new gonorrhea infections
- Kreisel, Kristen M. PhD∗; Spicknall, Ian H. PhD∗; Gargano, Julia W. PhD†; Lewis, Felicia M.T. MD∗,‡; Lewis, Rayleen M. MPH†; Markowitz, Lauri E. MD†; Roberts, Henry PhD§; Johnson, Anna Satcher MPH¶; Song, Ruiguang PhD¶; St. Cyr, Sancta B. MD∗; Weston, Emily J. MPH∗; Torrone, Elizabeth A. PhD∗; Weinstock, Hillard S. MD∗ Sexually Transmitted Infections Among US Women and Men: Prevalence and Incidence Estimates, 2018, Sexually Transmitted Diseases: April 2021 – Volume 48 – Issue 4 – p 208-214 doi: 10.1097/OLQ.0000000000001355
- CDC estimates 1 in 5 people in the U.S. have a sexually transmitted infection | CDC Online Newsroom | CDC
- CDC Gonorrhea fact sheet: Detailed STD Facts – Gonorrhea (cdc.gov)
- CDC Chlamydia fact sheet: https://www.cdc.gov/std/chlamydia/stdfact-chlamydia.htm
- CDC Trichomoniasis fact sheet: STD Facts – Trichomoniasis (cdc.gov)
Why does the Visby Medical Sexual Health Test include these three infections?
- As a diagnostic company, we understand that chlamydia and gonorrhea are currently two of the most widely spread STIs, making their quick diagnosis and treatment of high importance.
- Furthermore, STIs are frequently asymptomatic, with nearly 50% of gonorrhea cases and 80% of chlamydia cases being asymptomatic in women.
- Currently, there is no reporting requirement for trichomoniasis by public health authorities, meaning that there might be a significant under diagnosis and reported numbers of this STI.
- This is especially concerning as trichomoniasis has been identified to increase risk of contracting HIV two- to three-fold, raising the need for tracking and treating much more important over the last several years.
- Also, approximately 70% of all trichomoniasis cases are asymptomatic.
- A 2019 KFF poll found that a large share of the public is unaware of how common STIs are, with far less than half (36%) aware that STI rates are increasing every year.
What type of test is the Visby Medical COVID-19 Point of Care Test?
The Visby COVID-19 Point of Care Test is:
- single-use (disposable)
- a molecular diagnostic test
The device utilizes RT-PCR (reverse-transcriptase polymerase chain reaction) for the qualitative detection of ribonucleic acid from the SARS-CoV-2 virus. The Visby Medical COVID-19 Point of Care Test contains all components required to carry out an assay for SARS-CoV-2 in nasopharyngeal, nasal or mid-turbinate swabs.
What does instrument-free PCR mean?
For the person waiting for their result, instrument-free PCR means they have access to lab-quality results in under 30 minutes. The lab comes to the patient instead of the patient sample going to the lab.
For the healthcare professional, instrument-free means everything required to run a lab-grade PCR test is included within the test kit, including all of the necessary reagents and supplies. This translates to less hands-on time, no maintenance, no bottleneck or backup time, and no calibration costs.
Why choose Visby Medical’s PCR device?
Compared to the PCR instruments that exist in hospitals and laboratories today, the Visby Medical device is faster and easier to use, and it fits in the palm of your hand for portable use at the point of care.*
*Requires a CLIA Certificate of Waiver
How accurate are the results / What are your positive and negative percent agreement with lab-based PCR?
The concept of accuracy depends upon the comparator test used. The Visby Medical COVID-19 Point of Care Test has a 100% positive percent agreement, a 95.2% negative percent agreement, and a Limit of Detection (LoD) of 435 viral genome copies per swab. To best understand the performance please review our package insert for more detail.
What is a false positive? What is a false negative?
A false positive occurs when the test result incorrectly detects the presence of a virus when it is absent. A false positive can also be from the contamination or introduction of the virus/amplicon to the sample even though it is not present in the patient. A false negative is when the test fails to detect the presence of a virus even though the patient is actually positive.
How should I store the Visby device before, during, and after use?
Store the Visby Medical COVID-19 Point of Care Test in a cool and dry environment (36°F-86°F). Do not freeze. In case of refrigeration or other exposure to cold temperatures, ensure that the Visby device is allowed to come to its minimum operating temperature prior to use.
Do not remove the COVID-19 device from the foil pouch until the workspace is prepared and you are ready to run the test. When you are ready to run the test, make sure the COVID-19 device is at room temperature (66°F-82°F) on a clean, level surface, with the main label facing upward.
After use, the COVID-19 device, pastettes, and Visby Buffer should be disposed of in accordance with local regulations.
Is the Visby COVID-19 test available for home use?
No. Visby Medical received emergency use authorization (EUA) from the FDA for use in CLIA-waived settings, which includes locations in the US such as doctor’s offices, mobile labs/clinics, surgical centers, nursing homes, or any laboratory with a CLIA Certificate of Waiver.
How does Visby’s COVID-19 test compare to saliva-based tests?
Currently, all FDA EUA saliva-based tests are run on central laboratory systems (i.e. samples must be shipped to a central laboratory capable of running high complexity laboratory tests). As of March 16th, 2021, none of the approved saliva COVID-19 molecular tests are authorized by the FDA for use at point-of-care (POC) settings. Turnaround time for saliva tests is longer than 30 minutes (unlike the Visby Medical test). Existing saliva-based tests take at least three hours for results, plus additional time for transport, processing, and result reporting — the turnaround time is similar to a lab-based PCR test. The Visby Medical COVID-19 Point of Care Test is sensitive, easy-to-use, and delivers results in less than 30 minutes in a POC setting.
What is the difference between a molecular test, an antigen test, and an antibody test?
A molecular test, such as the Visby Medical COVID-19 Point of Care Test, detects the presence of virus genetic material (SARS-CoV-2 RNA) to help identify active infection. An antigen test detects specific proteins of the SARS-CoV-2 virus. Antigen tests also help to identify an active infection, but are generally less sensitive than molecular tests. An antibody test detects the presence of SARS-CoV-2 antibodies, the body’s immune response, to the COVID-19 virus. Antibody tests help determine past infection of COVID-19, but do not detect active infections.
Who may be tested using the Visby test? Does the individual need to be symptomatic?
The Visby Medical COVID-19 Point of Care Test is authorized for use for individuals suspected of COVID-19 by their healthcare provider.
What are CLIA-Certified Laboratories and Point of Care Settings?
Under CLIA, a laboratory is defined as a facility that performs applicable testing on materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of human beings.
Point of care includes settings such as physician offices, urgent care, outpatient clinics, pharmacies, and patient care settings that operate under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.