NEW! CE-IVD test provides tool for clinical diagnosis of Coronavirus (COVID-19)
At AEQUILIBRIUM PHARMA SRL, we are committed to providing our customers with high quality products and professional technical support for disease diagnosis and therapeutics.At this difficult time, we have Provide in association with several partners an assay to detect coronavirus (COVID-19) in patient samples and launched the Real-Time PCR Coronavirus CE and IgM/IgG Antibody Test KitOur test kits meet the requirements of EC Directive 98/79/EC, they could be sold in the European Community and other countries which agree with EC Directive 98/79/EC.
At AEQUILIBRIUM PHARMA SRL, we are committed to providing our customers with high quality products and professional technical support for disease diagnosis and therapeutics.
At this difficult time, we have Provide in association with several partners an assay to detect coronavirus (COVID-19) in patient samples and launched the Real-Time PCR Coronavirus CE and IgM/IgG Antibody Test Kit
Our test kits meet the requirements of EC Directive 98/79/EC, they could be sold in the European Community and other countries which agree with EC Directive 98/79/EC.
This Test Kits Are:
1) “Primerdesign TM Ltd” genesig® Real-Time PCR assay
This new molecular kit has been developed for the clinical diagnosis of COVID-19. RNA extracted from patient samples can then be analysed using the genesig Coronavirus (COVID-19) CE IVD test (validated against
ABI 7500 [Applied Biosystems],
CFX [Bio-Rad]
and LC480 [Roche]).
The detection profie of the kit displays zero cross reactivity with other related viruses and 100% homology with all published SARS-CoV-2 sequences.
Our COVID-19 CE IVD kit with lyophilised reagents is available with NO cold chain shipping globally
2)AMS LAB LTD 2019-nCoV IgG/IgM Device (2-30oC)
The 2019-nCoV IgG/IgM Device is a rapid chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to 2019-nCoV, a new strain of
coronavirus (nCoV), in whole blood, serum and plasma specimen.
Real-Time PCR Coronavirus (COVID-2019) CE
Real-Time PCR Coronavirus
(COVID-2019) CE
This new molecular kit has been developed for the clinical diagnosis of COVID-19. RNA extracted from patient samples can then be analysed using the genesig Coronavirus (COVID-19) CE IVD test (validated against ABI 7500 [Applied Biosystems], CFX [Bio-Rad] and LC480 [Roche]). The detection profie of the kit displays zero cross reactivity with other related viruses and 100% homology with all published SARS-CoV-2 sequences.
Our COVID-19 CE IVD kit with lyophilised reagents is available with NO cold chain shipping globally.
AEQ PHARMA ARE NOW OFFERING AMS UK brand NEW 2019-nCov IgG/IgM Rapid Test
AEQ PHARMA ARE NOW OFFERING AMS UK brand NEW 2019-nCov IgG/IgM Rapid Test
The test device has anti-human IgG and anti-human IgM immobilized on the membrane in two distinct areas of the test zone. Particles coated with 2019-nCoV antigen are loaded on the membrane near the sample well. During the test whole blood, serum or plasma sample is added to the sample well where it interacts with the antigen coated particles and any antibodies to 2019-nCoV present in the sample will bind to the antigen. The antibody-particle complexes migrate up the membrane by capillary action where they interact with the anti-human IgG and/or anti-human IgM in the test zone and are captured. A positive result is indicated when a coloured
line forms at the IgG and/or IgM test line. The absence of any line development at the test zone indicates a negative result. To serve as a procedural control, a coloured line should always appear at the control line area indicating that proper volume of specimen has been added and membrane wicking has occurred.
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AEQ PHARMA ARE NOW OFFERING AMS UK brand NEW 2019-nCov Elisa Assay offering high accuracy and quick results.
AEQ PHARMA ARE NOW OFFERING AMS UK brand NEW 2019-nCov
Elisa Assay offering high accuracy and quick results.
The COVID-19 ELISA is an enzyme linked immunosorbent assay (ELISA) for the qualitative detection of total antibodies to COVID-19 in human serum and plasma. It is intended for screening of patients suspected of infection with coronavirus disease 2019. This reagent is for In vitro diagnostic use only.
Real-Time PCR Coronavirus (COVID-2019) CEThis new molecular kit has been developed for the clinical diagnosis of COVID-19. RNA extracted from patient samples can then be analysed using the genesig Coronavirus (COVID-19) CE IVD test (validated against ABI 7500 [Applied Biosystems], CFX [Bio-Rad] and LC480 [Roche]). The detection profie of the kit displays zero cross reactivity with other related viruses and 100% homology with all published SARS-CoV-2 sequences.Our COVID-19 CE IVD kit with lyophilised reagents is available with NO cold chain shipping globally. This is the ultimate solution to sensitive, rapid and cost-effective clinical diagnosis of COVID-19.
Real-Time PCR Coronavirus (COVID-2019) CE
This new molecular kit has been developed for the clinical diagnosis of COVID-19. RNA extracted from patient samples can then be analysed using the genesig Coronavirus (COVID-19) CE IVD test (validated against ABI 7500 [Applied Biosystems], CFX [Bio-Rad] and LC480 [Roche]). The detection profie of the kit displays zero cross reactivity with other related viruses and 100% homology with all published SARS-CoV-2 sequences.
Our COVID-19 CE IVD kit with lyophilised reagents is available with NO cold chain shipping globally.
This is the ultimate solution to sensitive, rapid and cost-effective clinical diagnosis of COVID-19.
Product Description Kit Size Cataloque nr
genesig Real-Time PCR COVID-19 Kit (CE) 96 reactions Z-Path-COVID-19-CE
The genesig Real-Time PCR COVID 19-CE Kit is CE-IVD marked and intended for in vitro diagnostic use in Europe.
Background to Coronavirus (COVID-19)
COVID-19 is a contagious, novel strain of Coronavirus that emerged from Wuhan, China in December 2019. The virus is thought to be of zoonotic origin and likely to have spread from large seafood and animal markets by
human-animal contact in the city of Wuhan. The virus causes respiratory infection with symptoms including fatigue, fever, shortness of breath, respiratory failure, renal failure and death.
The pandemic is now affecting multiple countries with a variety of differentiated health and safety regulations.
This COVID-19 outbreak is proving diffiult to contain.
The genesig® Coronavirus (COVID-19) CE IVD test provides the tool to faciliate control of this outbreak.
Kit controls and standards
The kit includes an Internal Control to identify possible PCR inhibition, to measure extraction purity and to
confim the integrity of PCR run. Our CE kits come combined with Oasig™ Lyophillised Master Mix providing a complete one kit diagnostic system.
• Kit includes: oasig Lyophilised qPCR Master Mix, Primer & Probe Mix, Positive Control, Internal Extraction Control, No Template Control & Resuspension Buffers.
• Kit targets the RdRp gene (RNA dependant RNA polymerase), and has 100% homology with all publicly available sequences
• Rigorous validation performed, multiple studies include:
- Analytical sensitivity – Analysis of limit of detection
- Analytical specificity – Detection profile is specific to COVID-19. Performed bioinformatically (in silico) and in the laboratory (in vitro) against other organisms to ensure no cross reactivity.
- Reproducibility – 95% confidence interval within results to ensure data is consistent
- Repeatability – Intra and inter run variation confidence. Repeatability across different instrument manufacturers. Repeatability between users.
• Traceability of values assigned to calibrating of control materials. Assured through reference measurement procedures
• Comprehensive validation in concordance with ISO13485. Post-market maintenance of technical files, including strain information
• Total kit performance measurement and assurance provided
• Lyophilised kits with no dry ice shipping requirement
Kit includes:
• Positive Control Template
• Internal Extraction Control
• DNase/RNase free water
• Oasig Lyophilised qPCR Master Mi
KEY BENEFITS
• Rapid detection of COVID-19
• Highly specifi detection profie
• High priming effiiency
• Accurate controls to confim extraction, run and reaction validity
• Supplied lyophilised with no cold chain shipping
• Validated against nasopharyngeal and oropharyngeal swabs as well as sputum
• Multi Platform Capability
AEQ PHARMA ARE NOW OFFERING AMS UK brand NEW 2019-nCov IgG/IgM Rapid Test
Test Principle:
The test device has anti-human IgG and anti-human IgM immobilized on the membrane in two distinct areas of the test zone. Particles coated with 2019-nCoV antigen are loaded on the membrane near the sample well. During the test whole blood, serum or plasma sample is added to the sample well where it interacts with the antigen coated particles and any antibodies to 2019-nCoV present in the sample will bind to the antigen. The antibody-particle complexes migrate up the membrane by capillary action where they interact with the anti-human IgG and/or anti-human IgM in the test zone and are captured. A positive result is indicated when a coloured
line forms at the IgG and/or IgM test line. The absence of any line development at the test zone indicates a negative result. To serve as a procedural control, a coloured line should always appear at the control line area indicating that proper volume of specimen has been added and membrane wicking has occurred.
Reagents:
The test device contains anti-human IgG, anti-human IgM, 2019-nCoV antigen and goat anti-mouse IgG on the membrane of the 2019-nCoV IgG/IgM Rapid Test.
Performance Characteristics:
The 2019-nCoV IgG/IgM Device has been compared with a commercial PCR test the results indicating high specificity and sensitivity.
IgG Results
Relative Sensitivity: 100% (CI*: 86.0% - 100%) *Confidence Intervals
Relative Specificity: 98.0% (95% CI*: 89.4% - 99.9%)
Accuracy: 98.6% (95%CI*: 92.3% - 99.96%)
IgM Results
Relative Sensitivity: 85.0% (95%CI*: 62.1% - 96.8%)
Relative Specificity: 96.0% (95% CI*: 86.3% - 99.5%)
Accuracy: 92.9% (95% CI*: 84.1% - 97.6%)
Cross-reactivity
The 2019-nCoV IgG/IgM Device has been tested using samples positive for anti-influenza A
virus, , anti-influenza B virus, anti-RSV, anti-adenovirus, HBsAg, anti-syphilis, anti-H pylori,
anti-HIV and anti-HCV. The results showed no cross-reactivity of these samples in the test.
AEQ PHARMA ARE NOW OFFERING AMS UK brand Elisa Assay offering high accuracy and quick results.The COVID-19 ELISA is an enzyme linked immunosorbent assay (ELISA) for the qualitative detection oftotal antibodies to COVID-19 in human serum and plasma. It is intended for screening of patients
suspected of infection with coronavirus disease 2019. Summary and Principle:Coronaviruses are a large family of viruses that cause disease ranging from common cold symptoms tomore severe pneumonia. They are enveloped, single strand RNA viruses. Coronaviruses are zoonotic, they can be transmitted from animals to humans. Existing examples include the Middle East Respiratory Virus (MER-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV).Reports of a novel coronavirus began in the Wuhan district of China in December 2019 and in February 2020 the World Health Organisation designated the disease caused by the new strain as coronavirus disease 2019 (COVID-19). Symptoms include high tempe rature, cough and breathing difficulties. In immunocompromised individuals symptoms can be more severe leading to pneumonia, severe acute respiratory syndrome or death.For detection of COVID-19, the COVID-19 ELISA uses a double antigen sandwich ELISA method in which wells are pre-coated with recombinant COVID-19 antigen. Samples are added to and incubated in assigned wells. Any anti-COVID-19 antibodies present in the samples will bind to the immobilised antigen. The plate is washed to remove unbound sample components. Next conjugate, consisting of recombinant COVID-19 antigen conjugated to Horse Radish Peroxidase (HRP), is added to the wells and incubated. The conjugate will bind to and label the antibodies bound during the first step.Unbound conjugate is removed in another wash step. Then Chromogen solutions containing tetramethyl-benzidine (TMB) and urea peroxide are added to the wells where the HRP label on the immunocomplexes catalyses a reaction in the chromogens to form a blue coloured product. The blue colour turns yellow after stopping the reaction with acidic reagent. The colour intensity of the wells is measured spectrophotometrically and is proportional to the amount of antibody in the sample. Wells containing samples negative for anti-COVID-19 remain colourless.Perfect for large companiesUnlimited products
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ANTIVIRAL Key Intermediates For API and API for combact CORONAVIRUS/COVID-19
However, life and work must go on, and as a pharmaceutical practitioner, our company is trying our best effort to meet the urgent needs because of the COVID-19. We now can supply full range intermediates (intermediates for commercial, and APIs also available for research use) of Remdesivir, Oseltamivir,Baloxavir,ritonavir ， Lopinavir and Darunavir,which are being applied in the combat with this virus.
