COVID-19 DETECTION TECHNOLOGIES RAPID TEST ¡ PCR ¡ CLIA
Coronavirus SARS-CoV-2 Detection and Assay Development by ND Pharma & Biotech
The emergence of new viral diseases, including the coronavirus SARSCoV-2 (COVID 19) outbreak, highlighted the need for fast methods to detect and identify target viruses at scale.
The COVID-19 pandemic also illustrates how research efforts to develop drug treatments or vaccines are accelerated in times of urgent need. There is also a need for supplies and support for scientists working to curtail spread of the SARS-CoV-2 virus is urgent and immediate.
ND Pharma in association with certain partners support scientists working to understand the molecular mechanisms by which emerging viruses infect humans and animals, and to develop accurate detection methods.
We provide collaborative technical support, expertise and a variety of technologies to help all kind of operators, including public health institutions and governmental organizations in control and fight against this virus.
COVID-19 DETECTION TECHNOLOGIES RAPID TEST · PCR · CLIA
Real-Time Fluorescent RT-PCR Kit for 2019-nCoV Detection Certified · CE Mark INTENDED USE: The kit is a qualitative in vitro nucleic acid amplification assay designed for the ultrasensitive and rapid investigation of SARS-CoV-2. The kit has been awarded CE IVD marking and, now, is commercially available as a certified IVD in markets that acceot CE marking as valid regulatory approval..
FEATURES: • • • • • •
Samples to results in less than 3 hours Taqman Reverse Transcription PCR ORF1ab gene as domain target Human β–actin as internal control Manufacturing in ISO 13485 compliant and high-volume production facility Stringent QC with positive and blank controls
BENEFITS: • • • • •
Highly sensitive – Superior limit of detection Highly specific – No cross-reactivity with other major huma-related pathogens Fast – One-step duplex reaction with single target and internal control Easy to use – Pre-mixed primers, probes and enzymes Easy to interpret results – Analysis of one target with well defined controls
SPECIFICATIONS:
• • • •
50 reactions per kit Sample collected from throat swab or bronchoalveolar lavage fluid (BALF) Compatible with many major real-time PCR systems Limit of detection: 100 copies/ml
• •
Reagent stable under dark for 5 days at 2-8ºC or 6 months at -18ºC No cross-reactivity with human genome or 54 other human related pathogens
COVID-19 DETECTION TECHNOLOGIES RAPID TEST · PCR · CLIA
KEY COMPONENTS: Component
Volume
Quantity
2019-nCoV Reaction Mix
1mL/vial
1 vial
2019-nCoV Enzyme Mix
80μL/vial
1 vial
2019-nCoV Positive Control
750μL/vial
1 vial
2019-nCoV Blank Control
750μL/vial
1 vial
Description Reagents for amplification, probes and primers Taq polymerase, reverse transcriptase and uracil-DNA glycosylase (UDG) Mix solution of pseudo-virus with target virus genes and internal reference DNase/RNase free water
USE: ADD:
Template RNA + Reaction Mix + Enzyme Mix
RUN
ALNALYZE
COVID-19 DETECTION TECHNOLOGIES RAPID TEST · PCR · CLIA
ND PHARMA 2019-nCoV IgM (CLIA) Certified · CE Mark
INTENDED USE: The kit is an In Vitro chemiluminescence immunoassay for the qualitative determination of IgM antibodies to novel coronavirus (2019-nCoV IgM) in human serum or plasma using the chemiluminescence immunoassay analyser.
SUMMARY AND EXPLANATION OF THE TEST: The novel coronavirus (2019-nCoV) causes an epidemic of acute respiratory syndrome in humans, belonging to the genus Betacoronavirus. It has an envelope, particles are round or oval, often polymorphic, and the diameter is 60 ~ 140nm. Its genetic characteristics are significantly different from SARSr-CoV and MERSr-CoV. Research has shown that detection of IgM and IgG antiviral antibodies in the serum samples from a patient. After human infection in 2019-nCoV, its antigen stimulates the immune system to produce an immune response, and corresponding antibodies appear in the blood. Among them, 2019-nCoV IgM appears earlier, which are mostly positive after 3-5 days of onset and, then, 2019nCoV IgM titers decrease, the 2019-nCoV IgG potency rose rapidly. The titer of IgG antibody during the recovery phase may increase 4 times or more compared to the acute phase. This kit is mainly used for the assisted diagnosis of the novel coronavirus (2019-nCoV) infection.
PRINCIPLE OF THE TEST: The ND Pharma 2019-nCoV IgM (CLIA) assay is a capture chemiluminescence immunoassay. The sample, buffer, magnetic microbeads coated with anti-human IgM monoclonal antibody are mixed thoroughly and incubated, forming immune-complexes. After precipitation in a magnetic field, decant the supernatant, and perform a wash cycle. Then add 2019-nCoV recombinant antigen labelled with ABEI and incubate to form complexes. After precipitation in a magnetic field, decant the supernatant, and then perform another wash cycle. Subsequently, the Starter 1+2 are added to initiate a chemiluminescent reaction. The light signal is measured by a photomultiplier as relative light units (RLUs), which is proportional to the concentration of 2019-nCoV IgM present in the sample.
COVID-19 DETECTION TECHNOLOGIES RAPID TEST · PCR · CLIA
PERFORMANCE CHARACTERISTICS: Precision Precision for 2019-nCoV IgM assay was determined as described in the CLSI EP5-A3. 2 controls and 3 samples containing different concentration of analytic were assayed in duplicate at three sites on five days, with 3 runs per day, one lot of reagent for each run and 2 replicates per run. The result is summarized in the following table: Sample
Mean Value (AU/ml)
Repeatability N
SD (AU/ml)
Between-Lot
%CV
SD (AU/ml)
Between-Day SD
%CV
Between-Site
%CV
(AU/ml)
SD
Reproducibility
%CV
(AU/ml)
SD (AU/ml)
%CV
NQC
0.293
90
0.020
NA
0.006
NA
0.007
NA
0.007
NA
0.023
NA
PQC
3.920
90
0.167
4.26
0.046
1.17
0.062
1.58
0.284
7.24
0.339
8.65
S1
0.492
90
0.033
NA
0.016
NA
0.009
NA
0.012
NA
0.40
NA
S2
1.797
90
0.037
2.06
0.018
1.00
0.053
2.95
0.088
4.90
0.111
6.18
S3
3.411
90
0.076
2.23
0.000
0.00
0.049
1.44
0.226
6.63
0.244
7.15
Clinical sensitivity The clinical sensitivity was determined by confirmed novel coronavirus infected specimens. The clinical sensitivity for 2019-nCoV IgM assay was calculated to be 78.65%. When used in combination of 2019-nCoV IgM assay and 2019-nCoV IgG assay, the clinical diagnostic sensitivity is 89.89%. 2019-nCoV IgM (CLIA) Specimen Category
Clinical confirmed positive samples
2019-nCoV IgM (CLIA) + 2019-nCoV IgG (CLIA)
N
Positive
%Sensitivity
N
Positive
%Sensitivity
89
70
78.65 %
89
80
89.89 %
Clinical sensitivity The clinical specificity was determined by non- novel coronavirus infected specimens, normal samples and interference samples. The clinical specificity for 2019-nCoV IgM assay 2019-nCoV IgM (CLIA)
2019-nCoV IgM (CLIA) + 2019-nCoV IgG
(CLIA)
Specimen Category
Clinical confirmed positive samples
N
Positive
%Sensitivity
N
Positive
%Sensitivity
200
195
97.50 %
200
193
96.50 %
COVID-19 DETECTION TECHNOLOGIES RAPID TEST · PCR · CLIA
ND PHARMA 2019-nCoV IgG (CLIA) Certified · CE Mark
INTENDED USE: The kit is an In Vitro chemiluminescence immunoassay for the qualitative determination of IgG antibodies to novel coronavirus (2019-nCoV IgG) in human serum or plasma using the chemiluminescence immunoassay analyser.
SUMMARY AND EXPLANATION OF THE TEST: The novel coronavirus (2019-nCoV) causes an epidemic of acute respiratory syndrome in humans, belonging to the genus Betacoronavirus. It has an envelope, particles are round or oval, often polymorphic, and the diameter is 60 ~ 140nm. Its genetic characteristics are significantly different from SARSr-CoV and MERSr-CoV. Research has shown that detection of IgM and IgG antiviral antibodies in the serum samples from a patient. After human infection in 2019-nCoV, its antigen stimulates the immune system to produce an immune response, and corresponding antibodies appear in the blood. Among them, 2019-nCoV IgM appears earlier, which are mostly positive after 3-5 days of onset and, then, 2019-nCoV IgM titers decrease, the 2019-nCoV IgG potency rose rapidly. The titer of IgG antibody during the recovery phase may increase 4 times or more compared to the acute phase. This kit is mainly used for the assisted diagnosis of the novel coronavirus (2019-nCoV) infection.
PRINCIPLE OF THE TEST: The ND Pharma 2019-nCoV IgG (CLIA) assay is a capture chemiluminescence immunoassay. The sample, buffer, magnetic microbeads coated with anti-human IgG monoclonal antibody are mixed thoroughly and incubated, forming immune-complexes. After precipitation in a magnetic field, decant the supernatant, and perform a wash cycle. Then add 2019-nCoV recombinant antigen labelled with ABEI and incubate to form complexes. After precipitation in a magnetic field, decant the supernatant, and then perform another wash cycle. Subsequently, the Starter 1+2 are added to initiate a chemiluminescent reaction. The light signal is measured by a photomultiplier as relative light units (RLUs), which is proportional to the concentration of 2019-nCoV IgG present in the sample.
COVID-19 DETECTION TECHNOLOGIES RAPID TEST · PCR · CLIA
PERFORMANCE CHARACTERISTICS: Precision Precision for 2019-nCoV IgG assay was determined as described in the CLSI EP5-A3. 2 controls and 3 samples containing different concentration of analytic were assayed in duplicate at three sites on five days, with 3 runs per day, one lot of reagent for each run and 2 replicates per run. The result is summarized in the following table: Sample
Mean Value (AU/ml)
Repeatability N
SD (AU/ml)
Between-Lot
%CV
SD
Between-Day
%CV
(AU/ml)
SD (AU/ml)
%CV
Between-Site SD (AU/ml)
%CV
Reproducibility SD (AU/ml)
%CV
NQC
0.293
90
0.024
NA
0.005
NA
0.008
NA
0.023
NA
0.035
NA
PQC
3.915
90
0.199
5.08
0.069
1.76
0.032
0.82
0.265
6.77
0.340
8.68
S1
0.491
90
0.043
NA
0.015
NA
0.004
NA
0.013
NA
0.047
NA
S2
3.486
90
0.212
6.08
0.060
1.72
0.050
1.43
0.071
2.04
0.237
6.80
S3
9.807
90
0.159
1.62
0.122
1.24
0.082
0.84
0.639
6.52
0.675
6.88
Clinical sensitivity The clinical sensitivity was determined by confirmed novel coronavirus infected specimens. The clinical sensitivity for 2019-nCoV IgG assay was calculated to be 91.21%. When used in combination of 2019-nCoV IgM assay and 2019-nCoV IgG assay, the clinical diagnostic sensitivity is 95.60%. 2019-nCoV IgG (CLIA)
2019-nCoV IgM (CLIA) + 2019-nCoV
IgG (CLIA)
Specimen Category
Clinical confirmed positive samples
N
Positive
%Sensitivity
N
Positive
%Sensitivity
91
83
91.21 %
91
87
95.60 %
Clinical sensitivity
The clinical specificity was determined by non- novel coronavirus infected specimens, normal samples and interference samples. The clinical specificity for 2019-nCoV IgGassay was calculated to be 97.33%. When used in combination of 2019-nCoV IgM assay and 2019-nCoV IgG assay, the clinical diagnostic specificity is 96.00%. 2019-nCoV IgG (CLIA) Specimen Category
Clinical confirmed positive samples
2019-nCoV IgM (CLIA) + 2019-nCoV IgG (CLIA)
N
Positive
%Sensitivity
N
Positive
%Sensitivity
750
730
97.33 %
750
720
96.00 %
COVID-19 DETECTION TECHNOLOGIES RAPID TEST · PCR · CLIA
Test Kit COVID-19 IGg - IgM Colloidal Gold Technology Based 1 Test Kit 36,00€ Regular Price Certified · CE Mark ND Pharma & Biotech Company, in cooperation with 2 international partners form China and USA, has developed one of the first immunoassays for COVID-19 infection diagnosis. This test was widely used by Chinese CDC for detecting of infections and now it is available worldwide once infection was detected out of China. This system uses a formulation similar to rapid test used by Health Authorities. Due to logistic issues, delivery time is between 12 and 20 days. Orders will be served by chronological order. Quotations will be a maximum validity of 3 days. This test detects early marker and late marker, IgM and IgG antibodies in blood samples or even with a finger-stick as with glucose tests. It can be used in symptomatic and asymptomatic patients. The test is perfect for its use in rapid verification tests made by health professionals and, even, for personal use, hospitals, pharmacies, etc.
IMPORTANT RECOMENDATIONS: • •
In case of positive results, you should contact by phone with your health service enabled for this situation in your area. In case of negative results and if symptomatology is present, you should contact by phone with your health service enabled for this situation in your area, due to there is a risk of virus nesting, that is not detectable at the time of analysis.
The rapid test of combined antibodies IgM-IgG of ND Pharma & Biotech Company is used for qualitative detecting of IgM and IgG antibodies of the new coronavirus in human blood or plasma in vitro. Accuracy
COVID-19 DETECTION TECHNOLOGIES RAPID TEST · PCR · CLIA
Accuracy
• • •
It works with complete blood or plasma. It detects IgM and IgG Validated using PCR
• • • •
15 minutes per test Intuitive visual interpretation No special equipment required It can be used in situ by healthcare professionals, so no sample transport needed.
Fast
Applications of Coronavirus Test Kit COVID-19 IgG IgM – 1 test • • • • •
General population screening It allows a rapid examination and diagnosis in situ Designed for healthcare professionals: Hospitals, medical offices, pharmacies and laboratories It can detect asymptomatic carriers It can determine if the patient was recently affected by he virus, even if the virus is no longer present
Use Form (Blood, Plasma or Serum)
COVID-19 DETECTION TECHNOLOGIES RAPID TEST · PCR · CLIA
Interpretation of results
Changes in antibodies levels
IgM antibody appears firstly after virus infection and, then, IgG antibody appears in mid and late stage of infection. IgM/IgG antibodies test can determine if a patient is «recently infected by SARS-CoV-2» It is widely accepted that IgM provides a first defence line during viral infections. It is followed by an adaptation generation, with a high specific IgG for a long-term immunologic memory. Therefore, test of by SARS-CoV-2 IgM and IgG antibodies is an effective method for fast diagnosis of infection of COVID-19. In addition, IgM antibody detection against by SARS-CoV-2 tends to indicate a recent exposure to SARS-CoV-2, while a IgG SARS-CoV-2 antibodies detection will indicate a later
COVID-19 DETECTION TECHNOLOGIES RAPID TEST · PCR · CLIA
stage of infection. So this test combined antibodies test could provide information about the stage of infection too. Test Kit Sensitivity and Specifity versus PCR
Study confirmed with real time PCR
KIT CONTENT • • • • •
Instructional Video See our VIDEO about rapid test https://vimeo.com/399986635
Individual packaged test cassettes per the amount of kit tests: 1/25/40 Disposable pipette per the amount of kit tests: 1/25/40 Reagent (one container with enough content for kit tests: 1/25/40 Safety single-use lancets (Optional/Served Apart) User manual
www.ndpharmabiotech.com
ND Pharma & Biotech Co. 152-160 City Road, London, England United Kingdom
www.ndpharmabiotech.com info@ndpharmabiotech.com
MAKING LIFE BETTER
For further information and/or assistance contact us and/or your local distributor.
Copyright ©2018 ND Pharma & Biotech company Limited. The ND Pharma Logos, names and any other issues marked with „TM“ and/or © mars are property of ND Pharma & Biotech Company Limited and/or its affiliates. Depicted items here does not constitute an offer or invitation to treat neither implies any kind of guarantee over efficacy and or product applications, legality and/or effects. Please check your local authorities to confirm such extremes prior to any use and/or application.