In December 2019, a pandemic of Coronavirus disease 2019 (COVID-19), caused by SARS-CoV-2 virus (2019-nCoV), started in the city of Wuhan, capital of Hubei, China. SARS-CoV-2 is closely related to SARS-CoV(-1). Infection is primarily spreadthrough human-to-human transmission via respiratory droplets. Symptoms may range from fever, cough, and breathing difficulties to pneumonia and acute respiratory distress syndrome.

The German Robert Koch Institute points out that for early detection of an infection it is advisable to include SARS-CoV-2 / COVID-19 detection in the differential diagnostic considerations, if there is a relevant travel history or signs of viral pneumonia of unclear cause. Samples should be taken in parallel from the upper and lower airways, if possible, and tested by RT-PCR.

Infected persons usually develop detectable antibodies in the second week after the onset of symptoms. A seroconversion or a significant increase in titer for IgG antibodies in the same test system can indicate an acute infection,  especially in combination with corresponding symptoms. Thus, serological detection of antibodies serves as an ideal addition to molecular detection, which is recommended for acute diagnostics. Furthermore, the detection of IgG  antibodies is a clear indication of pathogen contact and can detect a past infection and can be used for epidemiological studies.

With immediate effect, MIKROGEN offers the recomWell SARS-CoV-2 IgG, IgA assays, ELISA kits for the reliable detection of IgG or IgA antibodies against SARS-CoV-2.

KEY FEATURES
recomWell SARS-CoV-2 IgG / CE-IVD
Art. No.: 7304 for 96 determinations

recomWell SARS-CoV-2 IgA / CE-IVD
Art. No.: 7305 for 96 determinations

• Very high sensitivity and specificity due to the use of highly purified recombinant nucleocapsid antigen
• Easy processing with the automated ELISA screening analyzers
• Identical processing as well as uniform and interchangeable reagents

To expand our serological COVID-19 / SARS-CoV-2 portfolio we now also offer a CE-marked test in recomLine format. The assay can be used for screening and confirmation.

KEY FEATURES
NEW: recomLine SARS-CoV-2 IgG / CE-IVD
Art. No.: 7374 for 20 determinations

• Very good performance thanks tot he use of different, recombinant SARS-CoV-2 specific antigens: nucleocapsid (NP), RBD and S1 of the spike protein
• Additional information thanks the detection of antibodies against seasonal coronavirus (HCoV)
• Easy handling and identical processing as other tests of the recomLine product line

Mikrogen GmbH offers two SARS-CoV-2 RT PCR assays: Firstly, a next version of its well-received Multiplex Real-time PCR assay ampliCube Coronavirus Panel as CE-IVD kit. The assay is able to broadly detect Coronavirus genomic nucleic acids and to differentiate MERS-CoV, SARS-CoV (including new SARS-CoV-2), and seasonal Coronaviruses (CoV-NL63, CoV-OC43, CoV-229E, and CoV-HKU1).

A second PCR test, a SARS-CoV-2 specific screening and confirmatory assay ampliCube Coronavirus SARS-CoV-2 has been recently made available also with CE-IVD mark.

KEY FEATURES
ampliCube Coronavirus SARS-CoV-2 / CE-IV
Art. No.: 50143 for 50 rxn
Product information

• Save and Fast: Screening and Confirmation in less than 3 hours
• Screening: Detection of RNA from SARS Coronavirus and SARS-Cov-2 with spezific marker in the E-Gen
• Confirmation: Detection of RNA from SARS-CoV-2 with specific Marker in Orf1a

ampliCube Coronavirus Panel / CE-IVD
Art. No.: 50142 for 50 rxn
Product information

• Save and Fast: Screeningtest for Corona viruses (including SARS-CoV-2), test result in less than 3 hours
• Detection of RNA from
  • MERS-CoV
  • SARS-Corona viruses (including SARS-CoV-2) with specific marker for screening in Orf1a
  • Humane seasonal circulating Corona viruses (hCoV NL63, OC43, 229E, HKU1)

• Ideal shorttest for Respiratory samples: Modular combination with ampliCube PCR-Tests for detection of further viral and bacterial pathogens possible

Use of various real-time PCR cyclers possible: Mic (Magnetic Induction Cycler), Roche LightCycler^® 480 Instrument II,
Qiagen Rotor-Gene^® Q, Bio-Rad CFX 96, Applied Biosystems (QuantStudio^TM 5 Dx), Stratagene Mx3000P, Applied Biosystems (ABI 7500, ABI 7300)

Information for other PCR cyclers on request.