July 21, 2021

Studies and Reports

Independently Published Studies and Reports

On Innova SARS-CoV-2 Rapid Antigen Tests (Lateral Flow Devices/Tests)

Innova SARS-CoV-2 rapid antigen tests have been evaluated against more than 130 other lateral flow test devices globally and have been selected by many customers, including the UK government, as an important COVID-19 mass screening tool to help them suppress the infection rate. Our tests have proven to be very effective in detecting individuals who are considered at risk for infecting others, regardless of symptoms. (Note: Infected does not necessarily mean infectious. Read more about Viral Kinetics here)

Independent studies have demonstrated that the Innova rapid antigen test detects 99.8% of infected individuals who are considered infectious to others. The Innova rapid antigen test can be used in regular testing of health care and essential workers, schools, factories, intermittent pre-event testing in low prevalence and wide scale serial testing in high prevalence areas to detect infectious asymptomatic.

The independent studies conducted on Innova Lateral Flow Devices (LFD) represents the largest accumulation of lateral flow testing data to-date and demonstrates the effectiveness of lateral flow testing in the identification of COVID-19. These studies are the first evidence to demonstrate that LFD is comparable to PCR in detecting potentially infectious individuals regardless of symptoms.

This represents the largest collection of LFD studies to-date with over 1.7 million tests.

Summary of Independently Published Studies on Innova Rapid Antigen Test (Lateral Flow Device/Test)

Performance of the Innova SARS-CoV-2 Antigen Rapid Lateral Flow Test in the Liverpool Asymptomatic Testing Pilot: Population-based Cohort Study

July 7, 2021

  • 5869 Asymptomatic adults with supervised LFT self-testing versus PCR
  • Innova LFD was shown to be successful in detecting asymptomatic individuals
  • Innova LFD, in an included study, was shown to detect 99.8% of all persons who are infected and are considered at risk for infecting others

Asymptomatic Testing for SARS-CoV-2 Using Antigen-detecting Lateral Flow Devices

July 7, 2021

  • A review of 10 studies with over 1.7 million participants tested: participants including symptomatic and asymptomatic, adults and children. Both self and professionally supervised testing with LFD results compared to PCR.
  • 30% of Infected Persons have no symptoms and contribute to the majority of new infections
  • Innova is the only well studied evidence-based LFD capable of meeting accuracy and scale required for asymptomatic screening and has proven ability to detect the current variants of concern without a decrease in sensitivity
  • Detects nearly 100% of infected asmptomatic individuals who are infectious to others.
  • Very little difference in the Specificity between self-testing (99.1%) and testing performed or observed by a professional (99.8%)

Key Points Summary: Asymptomatic Testing for SARS-CoV-2 Using Antigen-detecting Lateral Flow Devices (Evidence From Performance Data October 2020 to May 2021)

July 7, 2021

  • Innova LFD detects between 83-100% of infectious cases
  • Innova LFD false + (Positive result when actually not infected) is only 3/10,000
  • 30% of COVID Infected patients have no symptoms
  • The most important measure of the usefulness of a test is its ability to detect those who not only have infection but are infectious

Asymptomatic Testing Backed by New Research Studies (Press Release)

July 7, 2021

  • Summary of 3 of the worlds largest real-world use of Innova LFD
  • Latest data shows Innova LFD test is effective at detecting the Delta variant – now the most widely transmitted strain of COVID-19
  • Studies find accuracy of the test remains high whether it is performed by an experienced or inexperienced user

Technical Report: In vitro and clinical post-market surveillance of Biotime SARS-CoV-2 Lateral Flow Antigen Device in detecting the SARS CoV-2 Delta variant (B.1.617.2)

July 7, 2021

  • The Innova LFD detects Alpha, Beta, Gamma, Kappa and Delta Variants
  • The Innova LFD demonstrated no statistical or clinical difference exists between the detection of the Delta variant compared the Alpha variant across the range of viral concentrations

Comparative Performance of SARS-CoV-2 Lateral Flow Antigen Tests and Association with Detection of Infectious Virus in Clinical Specimens: A Single-centre Laboratory Evaluation Study

June 30, 2021

  • A head-to-head comparision study of six rapid antigen tests commercially available in the UK, including Innova LFT, were compared for specificity and sensitivity
  • Among the three LFDs selected for detailed comparisons, innova LFT was the test with highest sensitivity

COVID-19: Rapid Antigen Detection for SARS-CoV-2 by Lateral Flow Assay: A National Systematic Evaluation of Sensitivity and Specificity for Mass-testing

June 1, 2021

  • Innova LFD is one of the 4 out of 64 LFDs that had desirable performance characteristics
  • 8951 Innova LFD tests were performed with a kit failure rate of 5.6% (502/8951, 95% CI: 5.1–6.1), false positive rate of 0.32% (22/6954, 95% CI: 0.20–0.48)
  • Results suggested that LFDs had promising performance characteristics for mass population testing and can be used to identify infectious individuals

Lateral Flow Device Specificity in Phase 4 (Post Marketing) Surveillance

March 10, 2021

  • Public Health England and Oxford University Review of Studies: Of the 1.7 million tested, Innova LFD resulted in a specificity of 99.7%
  • The 1.7 million tests showed a PCR sensitivity of 94.8%