COVID-19 DETECTION TECHNOLOGIES by ND Pharma & Biotech

Page 1

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.


Turn static files into dynamic content formats.

Create a flipbook
Issuu converts static files into: digital portfolios, online yearbooks, online catalogs, digital photo albums and more. Sign up and create your flipbook.