CASPR Lyo-CRISPR Assays for
SARS-CoV-2 detection.
Innovative CRISPR-based solutions for
diagnosis of COVID-19.
COVID-19 Detection Kit
CASPR Lyo-CRISPR
SARS-CoV-2 assay
Our assays harness CASPR’s
proprietary CRISPR-Cas12 complex,
in a novel and convenient lyophilized
format, designed to detect
SARS-CoV-2 RNA sequences in
clinical samples with sensitivity and
specificity comparable to
gold-standard technologies.
Sensitivity & Specificity
Comparable to gold standard RT-qPCR.
High throughput and faster turnaround time
60 minutes for processing 96 samples in
parallel. 2 types of sample input:
(I) Purified RNA, (II) Direct from sample
User friendly
Lyophilized beads that minimize
operator intervention.
No specialized instruments
It requires just a heat block and our CASPR FAM Box.
Our simplified workflow
is comprised of the
following steps:
1
SAMPLE PREP
Our assays have been validated
with two different sample inputs:
Purified RNA: RNA can be
purified using commercially
available RNA purification kits
Directly from Sample: Directly
from swabs without prior RNA
purification
2
AMPLIFICATION
Viral RNA from SARS-CoV-2 is
reversed transcribed to cDNA
and amplified using primers
specifically designed to target
a region in SARS-CoV-2
genomic RNA
3
CRISPR
In presence of multiple copies
of the amplified DNA our
proprietary CRISPR-Cas12,
specifically configured to
detect the target region, is
activated and cleavages a
reporter molecule causing
fluorescence emission.
4
DETECTION
Fluorescence readout is
achieved in 5 minutes using
our FAM Box, a portable
and affordable device
associated to a software
that automatically interpret
the results
DNA and RNA Sample
Amplification
CRISPR Reaction
Detection
Workflow
Product Specifications
-
Feature
Direct from Sample Kit
Purified RNA kit
-
FDA Submission
EUA202431 (in review) *
EUA201639(in review) *
-
Sample type
Upper-respiratory specimens
Upper-respiratory specimens
-
Targets
2 regions in N gene and 1 region in orf1ab
1 region in N gene
-
Assay Controls
2Positive and extraction controls included
-
Analytical Sensitivity
25 copies/μl
7.5 copies/μl
-
Clinical Performance
97.87% sensitivity / 100% specificity
100% sensitivity & specificity
-
Inclusivity
100%
>99.5%
-
Specificity (Cross-Reactivity)
No observed cross-reactivity (tested in silico and wet)
-
Assay Time
~ 60 minutes
-
Format
Lyophilized reagents
-
Size
48 tests
-
* Distributed in accordance with Section IV.C.2 of Policy for Coronavirus Disease-2019 Tests During the Public Health
Product Specifications
-
Feature
FDA Submission
Direct from Sample Kit
EUA202431 (in review) *
Purified RNA kit
EUA201639(in review) *
-
Feature
Sample type
Direct from Sample Kit
Upper-respiratory specimens
Purified RNA kit
Upper-respiratory specimens
-
Feature
Targets
Direct from Sample Kit
2 regions in N gene and 1 region in orf1ab
Purified RNA kit
1 region in N gene
-
Feature
Assay Controls
Direct from Sample Kit
2Positive and extraction controls included
Purified RNA kit
Positive and extraction controls included
-
Feature
Analytical Sensitivity
Direct from Sample Kit
25 copies/μl
Purified RNA kit
7.5 copies/μl
-
Feature
Clinical Performance
Direct from Sample Kit
97.87% sensitivity / 100% specificity
Purified RNA kit
100% sensitivity & specificity
-
Feature
Inclusivity
Direct from Sample Kit
100%
Purified RNA kit
>99.5%
-
Feature
Specificity (Cross-Reactivity)
Direct from Sample Kit
No observed cross-reactivity (tested in silico and wet)
Purified RNA kit
>No observed cross-reactivity (tested in silico and wet)
-
Feature
Assay Time
Direct from Sample Kit
~ 60 minutes
Purified RNA kit
~ 60 minutes
-
Feature
Format
Direct from Sample Kit
Lyophilized reagents
Purified RNA kit
Lyophilized reagents
-
Feature
Size
Direct from Sample Kit
48 tests
Purified RNA kit
48 tests
-
* Distributed in accordance with Section IV.C.2 of Policy for Coronavirus Disease-2019 Tests During the Public Health
Ordering Information
and Support
#C301
Direct Caspr
Lyo-CRISPR SARS
Cov-2 Kit
Directly from sample
(48 patients)
