0.005 TCID50/ml detection limit,
10,000 times lower than current lateral flow tests and comparable to PCR with no specialist equipment or training required.
ACCURACY
Senzo commissioned three 3rd-party, head-to-head, blind studies to independently assess and verify the accuracy of the Senzo Amplified Lateral Flow (ALF) Covid-19 test against PCR. The studies were conducted by: (1) Sheffield University, (2) University College London, and (3) LateralDX
The studies collectively showed ALF tests to have >99% concordance with PCR across 75 positive and 75 negatives samples and demonstrated the ability of an ALF test to identify positive samples with low viral load, for example, those with Ct values higher than 30. Multiple studies have shown that existing lateral flow rapid antigen tests are unable to detect low viral load Covid-19 virus in patient samples. This results in a high false-negative rate, undermining test accuracy.
Sheffield University
The blinded study, led by infectious disease and COVID-19 researcher Dr. Thushan de Silva’s team, demonstrated Senzo’s Amplified Lateral Flow test is 100% accurate when compared to PCR results, including at very low viral loads.
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25 of 25 samples determined to be positive via PCR were determined to be positive on the Senzo ALF test
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25 of 25 samples determined to be negative via PCR were determined to be negative on the Senzo ALF test
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10 positive samples had PCR Ct values in the range of 30-38 and all of these samples were correctly identified as positive on the Senzo ALF test
UNIVERSITY COLLEGE LONDON
Senzo’s COVID-19 ALF devices were blind tested in a third-party study by Professor Reza Motallebzadeh’s group at the Department of Surgical Biotechnology, at the Royal Free Hospital, University College London.
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This study showed 25 out of 25 PCR-positives to be positive on ALF, a 100% Positive Percent Agreement
17 positive samples had Ct values higher than 30 which is generally considered to be very difficult for lateral flow devices to detect– all of which were detected as positive by ALF
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This study showed 24 out of 25 PCR-negatives to be negative on ALF, a 97% Negative Percent Agreement
The single false negative result was attributable to a one-off testing issue, and not thought to be related to true specificity
LATERALDX study
Senzo’s COVID-19 ALF devices were blind tested in a third-party study with Lateral Dx, experts in lateral flow test development and providers of in vitro diagnostic solutions on a contract basis to partner businesses. The Lateral Dx team were engaged to independently assess and verify the accuracy of the Senzo Amplified Lateral Flow Covid-19 test.
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This study showed 24 out of 25 PCR-positives to be positive on ALF, a 97% Positive Percent Agreement
9 positive samples had Ct values higher than 30 which is generally considered to be very difficult for lateral flow devices to detect– 8 of which were detected as positive by ALF
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This study showed 25 out of 25 PCR-negatives to be negative on ALF, a 100% Negative Percent Agreement
COVID-19
│
HIV
│
Flu A/B
│
Hepatitis C
│
Tuberculosis
│
C. Difficile
COVID-19 │ HIV │ Flu A/B │ Hepatitis C │ Tuberculosis │ C. Difficile
ALF Innovation
The Senzo Amplified Lateral Flow uses a novel method to bind Detection Reagent and Capture Antibody in the Test Zone, only if a target analyte is present.
Since Detection Reagent will only remain bound to Capture Antibody at the Test Zone if the analyte is present, it can be amplified without fear of amplifying noise and false positives, providing very high sensitivity. If the target analyte is not present, the Detection Reagent and Capture Antibody flow completely off the strip into the Absorption Pad and Amplification Reagent can be safely applied without impacting specificity.
Reach out to the Senzo team
JAKE RABY, MSc.
VP BIOASSAY DEVELOPMENT
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