COVID-19 (Coronavirus) – Our Commitment
COVID-19 IgG/IgM Rapid Test Cassette – FDA Emergency Use Authorized
The COVID-19 IgG/IgM Rapid Test Cassette is a lateral flow immunochromatographic assay for the detection of SARS-CoV-2 antibodies in venous whole blood, serum or plasma. The COVID-19 IgG/IgM Rapid Test Cassette is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
COVID-19 (Coronavirus Disease) is the infectious disease caused by the most recently discovered coronavirus. This new virus and disease were unknown before the outbreak began in Wuhan, China, in December of 2019. The COVID-19 rapid test is manufactured by Hangzhou Biotest Biotech, Co., Ltd. and distributed by Premier Biotech. For product inquiries and to request additional information, please contact Premier Biotech at: 888-686-9909.
EUA Authorized Documentation:
EUA Authorized Serology Test Performance – Hangzhou Biotest Biotech RightSign COVID-19 IgG/IgM Rapid Test Cassette
- Developer: Hangzhou Biotest Biotech
- Test: RightSign COVID-19 IgG/IgM Rapid Test Cassette
- Technology: Lateral Flow
- Target: Spike
Statements And Conditions:
- This test has been authorized by FDA under an EUA for use by authorized laboratories;
- This test has not been FDA cleared or approved;
- This test has been authorized only for the presence of lgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens;
- This test 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)(l) of the Act, 21 U.S.C. § 360bbb-3(b)(l), unless the authorization is terminated or revoked sooner.
- This product is not for home use (Emergency Use Authorization – In Vitro Diagnostic Use Only)
- Not for screening of donated blood
Safe Drug Screening Product Options By Industry
Workplace
Safe And Effective Solutions For Workplace Testing Scenarios
Alleviate Collection Concerns With Rapid Oral Fluid Screening
Last busy season, an estimated 60% of candidates that were told to report to a collection site never executed the test. Now with COVID-19 virus concerns, requesting candidates to provide a urine screen at a collection site is not a sustainable option. With safety at the forefront of our efforts, utilizing rapid oral fluid testing with OralTox can alleviate these concerns. With Premier Biotech’s FDA 510(k) cleared oral fluid test, employers have a safe and reliable option while securing results in just minutes.
Urine Based Collection Site Screening Concerns
- Close proximity in collection site waiting rooms increases the possibility of spreading the virus among other things
- Sanitation concerns with heavily used restrooms
- Inability to adhere to CDC recommended 6′ of separation
- Additional time requirements to prepare each collection while assuring adherence to safe collection procedures
Rapid Oral Fluid Testing Benefits
- While observed, the Donor completes the collection process without direct contact from the Administrator
- Administrator remains at a safe distance
- The donor seals the collection swab into the OralTox device themselves
- Removes concerns with high traffic collection site lobbies in which employees or candidates could potentially be exposed to COVID-19
- Expansive lab confirmation testing menu for the small % of inconclusive results
Workplace Safety Remains A Top Priority
Due to the increasing uncertainty the COVID-19 virus is causing, drug abuse in the workplace can pose a number of potential risk factors. Maintaining a safe and effective drug testing protocol during this time is imperative to help avoid increased cases of employee drug abuse, theft and workplace safety concerns.
Donor Collection
Secure Screening
Results In Minutes
Government
Safe And Effective Solutions For Agency Run Drug Testing Programs
Maintain Accountability Anywhere
COVID-19 virus concerns continue to spread at a drastic rate. With many agencies and county offices closing or limited their hours, urine drug screening may not be a suitable option at this time. With safety at the forefront of our efforts, utilizing rapid oral fluid testing with OralTox will allow your testing criteria to continue.
Possible Limitations With Urine Based Screening
- Possible Limitations With Urine Based Screening
- Close proximity of individuals in restrooms
- Sanitation concerns with heavily used restroom
- Challenges when offices closed/limited hours
- Field testing limitations/requirements
- Inability to adhere to CDC recommended 6 feet of separation from others
Rapid Oral Fluid Testing Benefits
- Rapid Oral Fluid Testing Benefits
- Ideal in the field when offices are closed/limited hours (Test anytime and anywhere)
- While observed, the Donor completes the collection process independently
- Allows the Administrator to remain at a safe distance (CDC recommended 6’)
- The donor seals the collection swab into the device themselves
- Device can be sent to lab for confirmation testing without the need for a 2nd sample (small % of inconclusive results only)
Donor-Driven Testing Holds Offenders Accountable
Due to the increasing stress and uncertainty the COVID-19 virus is causing, drug abuse is expected to rise, posing a number of potential risk factors and consequences. Rapid oral fluid screening with OralTox can be a tool to ensure screening continues either in the field when county agencies close/limit hours or onsite. Donor-driven testing helping to hold offenders accountable while protecting our communities.
Donor Collection
Secure Screening
Results In Minutes
Clinical
Safe And Effective Solutions For Clinical Screening Programs
Alleviate Safety Concerns With Rapid Oral Fluid Screening
Premier Biotech recognizes adhering to the Centers for Disease Control and Prevention (CDC) guidance, being in close proximity to others can elevate the likelihood of spreading the COVID-19 virus. With safety at the forefront of our efforts, utilizing lab based oral fluid testing with the Intercept i2he can alleviate concerns adhering to this guidance.
Urine Collections – Clinical Based Challenges
- Close proximity of individuals in restroom
- Sanitation concerns with heavily used restroom
- Inability to adhere to CDC recommended 6 feet of separation from others
- Additional time requirements to prepare each collection while assuring adherence to safe collection procedures
Lab Based Oral Fluid Testing Benefits
• While observed, the Donor completes the collection process independently
• Allows the Administrator to remain at a safe distance (CDC recommended 6’)
• While wearing protective gloves, the donor seals the collection vial themselves
• Removes the need for sanitized restrooms and same gender collectors
• Expansive lab based oral fluid testing menu
Patient Treatment And Community Safety Remains A Priority
Individuals with substance use disorders can be more likely to abuse drugs due to the increasing uncertainty the COVID-19 virus is causing. Maintaining a safe and effective drug screening/treatment program is imperative to help avoid increased cases of relapse and posing potential risks to the patient and community.
Swab
Slide
Seal
Our Unwavering Commitment
With growing concerns of COVID-19 (coronavirus), Premier Biotech would like to reiterate our unwavering commitment to providing safe and reliable drug testing solutions and on-going support to our customers. As we continue to monitor developments with COVID-19, we invite you to contact us anytime at 888-686-9909 so we can provide you with our expertise and options to minimize any possible disruptions in meeting your drugs of abuse screening needs.