MHH SARS-COV-2 Antigen Rapid Test Kit (Colloidal Gold)

Set of fast cassette tests for detecting the SARS-CoV-2virus antigen(Colloidal Gold)

The test is used for qualitative in vitro detection of SARS-CoV-2nucleocapsid antigen in nasal swab(NS)samples taken directly from persons with suspected COVID-19infection, confirmed by a primary care physician within the first 5 days of developing symptoms of infection.The test is intended exclusively for professional use in clinical laboratories or by healthcare professionals in testing points.The test meets the highest global standards for medical equipment and is currently in the process of being registered at EUL WHO.

COVID-19

TEST

First Polish test distinguishing between COVID-19 and Influenza
– MediPan FAST COVID + FLU

As a result of partnership between the Institute of Bioorganic Chemistry of the Polish Academy of Sciences and Medicofarma S.A., at the beginning of 2012, the first Polish test distinguishing between COVID-19 and influenza infections was launched. The MediPAN-COVID+Flu test offers a fast and reliable method of determining if a patient has contracted SARS‑CoV‑2 or the influenza virus. Common usage of the differentiating test will be of critical importance when the influenza season overlaps with the third wave of the pandemic. The MediPAN-COVID+Flu genetic test is intended for detecting two specific genes of SARS-CoV-2 as well as one specific gene for influenza type A and B. The test kit was designed to detect the SARS‑CoV‑2 and the influenza virus in the same reaction well. At the same time, the test kit provides a control reaction to verify if the smear was taken correctly, to avoid false negative results caused by incorrect sample collection.

Medicofarma S.A launches
the first Polish Covid-19 test.

MediPAN COVID SARS-CoV-2 is the first Polish genetic test for detecting the SARS-CoV-2 virus. The test was developed by the Institute of Bioorganic Chemistry of the Polish Academy of Sciences in Poznań. Medicofarma S.A. handled product implementation from the laboratory scale to manufacturing, as well as comprehensive manufacturing of the test kits.

The MediPAN-2G+ FAST COVID test is considered to be one of the fastest and most accurate tests among the currently available COVID tests. Features a short RT-PCR reaction time – approx. 1 hour. This allows to obtain a result for the patient much more quickly. Sensitivity of virus detection reaction is estimated at >99%.

Our test confirms the presence of the virus in the course of two independent reactions designed to detect two specific genes of the SARS-CoV-2 coronavirus. This is a significant advantage over screening tests in which one of the detected genes is typical for the entire coronavirus family.

Scientists from the Polish Academy of Sciences began working on the test in March 2020, that is from the beginning of the outbreak. The MediPAN-2G+ FAST COVID test which we introduced to the market was approved by the National Institute of Public Health – National Hygiene Association in Warsaw. Thanks to the involvement of Medicofarma S.A and using domestically-available reagents, the price of the COVID-19 antibody test was significantly reduced.

TEST GENERATIONS
FOR DETECTING THE
SARS-COV-2 VIRUS

MHH SARS-COV-2 Antigen Rapid Test Kit (Colloidal Gold)

The test is used for qualitative in vitro detection of SARS-CoV-2nucleocapsid antigen in nasal swab(NS)samples taken directly from persons with suspected COVID-19infection, confirmed by a primary care physician within the first 5 days of developing symptoms of infection.The test is intended exclusively for professional use in clinical laboratories or by healthcare professionals in testing points and is not intended for home use. The coronavirus 2 (two) of acute severe acute respiratory syndrome (SARS-CoV-2 or 2019-nCoV) is an enveloped virus with non-segmented, positive-sense RNA. It causes the coronavirus disease (COVID-19)which is infectious to humans.

The SARS-CoV-2virus has severalstructural proteins, including spike (S), envelope(E), membrane (M) and nucleocapsid(N). Generally, the antigen is detected in samples taken fromtheupper respiratory tract in the course of an acute infection.A positive result means virus antigens were detected, however, it is necessary to combine the clinical result with the patient’s medical history and other diagnostic information to evaluate the state of the infection.A positive result does not exclude a bacterial infection or co-infection with other viruses.The detected factor may not be the final cause oftheillness.On the other hand, a negative result of the test must be treated as probable, which does not exclude SARS-CoV-2 infection and should not be treated as the sole basis for deciding about the treatment and handling of the patient, including decisions related to infection control.A negative result should be established within the context of the patient’s recent contacts, their medical history and the presence of any clinical signs and symptoms which may be characteristic for a COVID-19infection.The result should be confirmed through molecular testing, if required for deciding subsequent handling of the patient.

MediPan FAST COVID + FLU

Our latest test, MediPAN FAST COVID + FLU, the only test of this kind manufactured in Poland detects SARS-CoV-2 viruses as well as type A and B influenza, it is dedicated for use by professional laboratories using RT-PCR technology. The test was developed by the Institute of Bioorganic Chemistry of the Polish Academy of Sciences in Poznań. The test detects a highly specific fragment of two SARS-CoV-2 genes: ORF1ab (nsp2) and gene S, together with the specific fragments of influenza virus type A (gene PB1) and B (gene M). The control reaction detects human gene ACE2 with a high level of expression in the upper respiratory system epithelium cells. The test kit was designed so that a sample taken from one patient is analyzed simultaneously in four reactions per well. The control reaction allows to verify material extraction and sample quality. The main features facilitating the easy usage of the test kit are:

Simple interpretation
of result
High sensitivity
of virus
detection reaction
Signal detection
in four channels
per well
Short reaction
time, approx.1h,

MediPAN-2G+ FAST COVID

Developed by the Polish Academy of Sciences Institute of Bioorganic Chemistry in Poznań, the MediPAN-2G+ FAST COVID test is dedicated for use by professional laboratories using RT-PCR technology to detect SARS-CoV-2. The presence of the virus is confirmed in two independent reactions primed for two SARS-CoV-2 genes (a so-called single-well test). Additionally, a control reaction is carried out to verify the material preparation procedure. The main features facilitating the easy usage of the test kit are:

Simple interpretation
of result
High sensitivity
of virus
detection reaction
Signal detection
in four channels
per well
Short reaction
time, approx.1h,

MediPAN-2G+ COVID

Developed by the Polish Academy of Sciences Institute of Bioorganic Chemistry in Poznań, the MediPAN-2G+ COVID test is dedicated for use by professional laboratories using RT-PCR technology to detect SARS-CoV-2. The presence of the virus is confirmed in two independent reactions primed for two SARS-CoV-2 genes. Additionally, a control reaction is carried out to verify the material preparation procedure. It is the so-called single-well test kit.

Simple interpretation
of result
High sensitivity
of virus
detection reaction
Signal detection
in four channels
per well
Short reaction
time, approx.1h,

MediPAN-2G COVID

Developed by the Polish Academy of Sciences Institute of Bioorganic Chemistry in Poznań, the MediPAN-2G COVID test is dedicated for use by professional laboratories using RT-PCR technology to detect SARS-CoV-2. The presence of the virus is confirmed in two independent reactions primed for two SARS-CoV-2 genes. Two additional control reactions allow to: (I) evaluate the quality of the analyzed material (through analyzing the human gene expression ) and (II) control the material preparation procedure. Additionally, it allows to verify if the swab sample was taken correctly. It is the so called double-well test kit. It is also the second test manufactured in Poland after MediPAN COVID.

Simple interpretation
of result
High sensitivity
of virus
detection reaction
Signal detection
in four channels
per well
Short reaction
time, approx.1h,

TEST KIT MANUALS

DOUBLE-GENE SINGLE-WELL “FAST” KIT INSTRUCTIONS DOWNLOAD

DOUBLE-GENE DOUBLE-WELL KIT INSTRUCTIONS DOWNLOAD

DOUBLE-GENE SINGLE-WELL 2G+ TEST KIT INSTRUCTIONS OF USE

MediPan FAST COVID + FLU TEST KIT INSTRUCTIONS OF USE