MEDSAN COVID-19 IGM/IGG RAPID TEST - WHEN TIME COUNTS - EASY DETECTION IN 10 MINUTES - FASTLY
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MEDsan COVID-19 IgM/IgG Rapid Test
When time counts -
easy detection in 10 minutes
© MEDsan UK | 5/2020
About MEDsan UK
MEDsan UK |
MEdsan UK works with the German office of MEDsan Gmbh assisting with global sales. MEDsan GmbH is a spin-off out of sanPharma GmbH and is an Independent company
focusing on development, manufacturing and marketing of pharmaceutical and medicinal products.
sanPharma GmbH
Founded in 1978 by Gerhard Schröder, was taken over by Dr. Thomas Wüstefeld, PHD in 2014. Since then, there has been a continuous expansion of the product portfolio in in our
company of isopathic and immune-biological drugs.
• Highly bioavailable dietary supplements
• Supportive medical cosmetics
• Medical devices
Other Facts
• Annual sales of 126m €
• Due to the ownership structure of our family firm, we have short decision-making channels when making financial decisions.
• A continuously growing company group with over 280 employees
• Distribution in over 42 countries worldwide
• According with CGMP criteria (Continuous Good Manufacturing Practice)
• Certificate of Hazard Analysis and Critical Control Points (HACCP)
• Certificate of GDP (Good Distribution Practice)
• Certificate of Compliance with the GMPA approval as a testing laboratory by the DAkkS (Deutsche Akkreditierungsstelle GmbH) according to
DIN EN !SO/IEC 17025 including the guidelines 90/385 EWG, 93/42 EWG for the fields of competence according to the guidelines 90/385 EWG and DIN EN
ISO/IEC 17025 for biological, chemical, physical and microbiological-hygenic testing of medical devices and environmental monitoring by the ZLG (Zentralestelle
der Länder für Gesungheitsschutz bei Arzneimitteln und Medizinprodukten) accredited testing
• Benefiting from the spin-off from sanPharma GmbH, we have 44 years of experience, especially in immunobiological and isopathic pharmaceuticals, medical devices and dietary
supplements, our compounds combine years of experience with the latest scientific knowledge.
• For more than 30 years, sanPharma GmbH has been supplying 46 drugs/OTC products to the US market. During this time, MEDsan GmbH received no complaints, product recall
actions or other quality issues.
• Together with our partners and clients, we exclusively develop products that are already well established in natural medicine. Our customers benefit from our know-how and our
own development and manufacturing. By this we guarantee that you receive innovative products of the highest quality
© MEDsan UK | 5/2020 Page 2
Key Facts
MEDsan Covid-19 IgM/IgG Rapid Tests were sold into (sold/ordered) as of 19/04/2020
• Spain (0 / 13M) • Mexico (200 / 12M)
• Italy (400K / 2.5M) • El Salvador (80 / 500K)
• Monaco (100K / 300K) • Colombia (80 / 700K)
• Switzerland (400K / 1.5M) • Brazil (NDA)
• Poland (200K / 2.4M) • Sweden (2K / 450K)
• USA (200 / 13M) • Norway + Finland (200 / 600K)
• Germany (NDA) • Russia (NDA)
MEDsan Covid-19 IgM/IgG Rapid Tests were sold to (among others)
• Prof. Dr. Med. Dietrich H.W. Grönemeyer (GER) • University Hospital LA (US)
• Asklepios Hospital Group (GER) • State Hospital Mexico City (MEX)
• University Hospital Bern (SWZ) • University Hospital Zurich (SWZ)
• Marbella, Madrid and Barcelona Hospitals (SP)
Production Capacity
Our capacities can be scaled up at any time depending on market needs.
MEDsan Covid-19 IgM/IgG Rapid Test
• MEDsan GmbH Facilities 700, 000 pcs / Day
© MEDsan UK | 5/2020 Page 3
Management Summary
• MEDsan Covid-19 IgM/IgG Rapid Test is a solid phase immunochromatographic assay for the rapid, qualitative
and differential detection of IgM and IgG antibodies against novel coronavirus SARS-CoV-2 infected cells in
human blood, serum or plasma
• It is possible to detect past infections, to indicate the immune status of patients and identify the individuals
with adaptive immune response
• RT-PCR and antibody testing (MEDsan Rapid Test) can be used as complementary diagnostic tools to cover the
whole course of infection as well as previous infections
• Our test kit provides results within 10 minutes
• The test kit is available in two sizes: Rapid Test Single Box and Rapid Test Box 25
• The test kit does not react with other antibodies caused by different viruses such as EV17, CA16, ADV, ANA, Influenza
A, Influenza B, H1N1, H7N9, Haemophilus, Respiratory Synical Virus, Adenovirus, Rhinovirus, Mycoplasma, Chlamydia,
Pneumococco, Parainfluenza1-4, Streptococcus, MycobacteriumTuberculosis, Measles, Rubella, EB Virus, HIV, HCV, TP,
HBV, Enterovirus 71, Coronavirus 229E, Coronavirus NL 63, Coronavirus OC 43, Coronavirus HKU1
© MEDsan UK | 5/2020 Page 4
Time Critical Management of Diagnosis As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test but should only be made by the physician after all clinical and laboratory findings have been evaluated © MEDsan UK | 5/2020 Page 5
Why MEDsan? Unique Selling Points The test kit provides results about antibodies against SARS-CoV 2 in the specimen • Screen anywhere • Manufactured in Germany to the highest specification • Clinical sensitivity 96.88% • Ideal workplace screening tool • Easy to use • Identifies infection even in mild and asymptomatic cases • Results in 10 - 15 minutes • Suitable for all ages • CE marked Medical Device • Registered in the European Union © MEDsan UK | 5/2020 Page 6
Test Kit Components
Test Procedure
• Sealed pouches each contain a test kit,
a 5 µL mini plastic dropper and a desiccant
• Safety lancets
• Alcohol prep pads
Alcohol Prep Pad Safety Lancet
• Buffer
• Package insert
Test Cassette
Buffer Plastic Dropper
Pouch
Rapid Single Test Box vs Rapid Test Box 25
Rapid Test Single Box Rapid Test Box 25
1 Test Device 25 Test Devices
1 Safety Lancet 25 Safety Lancets Rapid Test Single Box
1 Alcohol Prep Pad 25 Alcohol Prep Pads
1 Pipette 25 Pipettes
1 Package Insert 1 Package Insert
1 Buffer 1 Buffer / 25 Buffers Rapid Test Box 25
© MEDsan UK | 5/2020 Page 7
STEP 1 STEP 2 STEP 3
After allowing the kit Using the sterile lancet Extract 5 µL of blood
to stand at room temperature prick your finger to start using the pipette - this
for at least 30 minutes, blood flow. should nearly fill it.
open the alcohol disinfectant Wipe off the first drop with
prep pad and thoroughly the sterile prep pad.
clean the finger that the blood
sample will be taken from. You will be using the second
drop for testing.
STEP 4 STEP 5 STEP 6
Apply 2-3 drops of blood Then apply 2 drops of Wait 10 minutes then
to the blood well on the buffer (about 60 µL) read the result.
test device. to the buffer well.
Make sure to use the correct Again make sure to use
well as indicated in the the correct well as
diagram. indicated in the diagram.
BLOOD WELL 10 MINUTES
BUFFER WELL
© MEDsan UK | 5/2020 Page 8Interpretation of Test Results
POSITIVE NEGATIVE INVALID
At least one purple/red line appears ONLY a purple/red line appears NO purple/red line appears on the
on the IgG (G) or IgM (M) lines AND on the Control line (C) Control line (C) regardless of any
one purple/red line appears on the purple/red lines appearing
Control line (C) elsewhere
PLEASE NOTE
• A negative result for an individual subject indicates absence of detectable anti-COVID-19 antibodies. However a negative test result does not preclude the possibility
of exposure to or infection with COVID-19.
• A negative result can occur if the quantity of the anti-COVID-19 antibodies present in the specimen is below the detection limit of the assay, or the antibodies that
are detected are not present during the stage of disease in which a sample is collected.
© MEDsan UK | 5/2020 Page 9Interpretation of Results NEGATIVE: If only the C band is present, the absence of any burgundy colour in the both T bands (IgG and IgM) indicates that no anti-COVID- 19 antibodies are detected in the specimen. The result is negative. Repeat 7 days later if concerned. Maintain social distancing. IgM POSITIVE: In addition to the presence of C band, if only IgM band is developed, the test indicates for the presence of IgM anti-COVID-19 in the specimen. The result is IgM anti-COVID-19 positive. Self-Isolate for 14 days. Repeat test after 7 days and ensure you follow Government guidelines. IgG POSITIVE: In addition to the presence of C band, if only IgG band is developed, the test indicates for the presence of IgG anti-COVID- 19 in the specimen. The result is IgG anti-COVID-19 positive. Past infection confirmed if the person has now fully recovered. Essential to advise NHS / Doctor for tracing of contacts. IgG and IgM POSITIVE: In addition to the presence of C band, both IgG and IgM bands are developed, the test indicates for the presence of both IgG and IgM anti-COVID-19 in the specimen. The result is IgG and IgM anti-COVID-19 positive. Definite infection, however, if you show no symptoms it is an indicator you have / had the infection and are recovering. INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test kit IF YOU TEST POSITIVE • You must immediately self-isolate to prevent spreading the virus to others • You should Contact the NHS on 111 who will advise you on the next steps to take Aggressive testing and social distancing measures will ensure we can eliminate the threat of a second wave of Coronavirus. As of 12th April 2020, only 1% of the UK population has been tested. © MEDsan UK | 5/2020 Page 10
Contact Us
To order the MEDSan Cov-19 IgM/IgG Rapid Test
• Sales Enquiries
Tel +44 20 3510 6826 | +44 20 3510 6827
Email enquiries@sticmedical24.com
Smart Technology Intensive Care Limited have a re-sale / partnership agreement in place with
MEDsan UK to distribute to but not limited to the following sectors –
• UK Government
• NHS
• Emergency Services (Police, Fire, Ambulance)
• Entertainment Industry
• UK Sports Industry
• Music Industry
• Financial Sector
© MEDsan UK | 5/2020 Page 11You can also read
