REAL TIME PCR MOLECULAR TESTING

 

State-of-the Art PCR tests in the fight against Covid-19

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Clinical high efficient diagnostic reagent solution

Consortium International Holdings continues to make available a state-of-the art PCR for the detection of SARS-CoV2. Now we are taking new steps forward in the introduction of our new SARS-CoV2 + Influenza A/B Detection Kit Novel coronavirus pneumonia is an acute lower respiratory tract infection caused by SARS-CoV-2. Our SARS-CoV-2 Detection Kit (Fluorescence PCR) is suitable for detection of ORF1ab and N gene of SARS-CoV-2.

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SARS-CoV-2 Detection Kit

(Fluorescence PCR)

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Consortium International offers a cost-effective and high performance SARS-CoV-2 Detection Kit (Fluorescence PCR) molecular diagnostic platform. Available under either the Healgen or the Orient Gene brand, our SARS-CoV-2 Detection Kit carries the European Union CE Mark, allowing their use in all countries adhering to the EU Declaration of Conformity. ​Our Healgen SARS-CoV-2 Detection Kit (Fluorescence PCR) molecular diagnostic platform has received the US FDA PEUA which allows distribution and use within the USA.

 

Our SARS-CoV-2 Detection Kit (Fluorescence PCR) molecular diagnostic platform offers the advantage of sharply reduced run times, delivering test results within 65 to 80 minutes vs other standard PCR tests.  In addition, our PCR requires fewer processing steps during the process of the test sample.

 

Our SARS-CoV-2 Detection Kit (Fluorescence PCR) molecular diagnostic platform is designed around the ORF1ab and N genes of 2019-nCoV. A primary advantage of the test is that it is extraction free. The reverse transcriptase and DNA polymerase we use are targeted modified to obtain high resistance to impurities from specimens, like plasma, mucoprotein, metal ions etc. High resistance to impurities allows the user to skip the nucleic acid extraction and purification processes, to make the test easier for users.

Features & Benefits Specimen Type

 

• Simple operation - Running real-time PCR

   without RNA extraction

• FAST - Sample to Result < One hour

• Pollution-free - One step RT-PCR

• Less time - Higher throughput

• Throat swab, nasal swab or sputum

 

Specimens can be read from a variety of existing PCR readers. However, we also offer two PCR readers, a portable reader as well as a lab based reader..

Instructions are available in English as well as in Spanish

 
 
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SARS-CoV-2 + Influenza A/B Detection Kit

(Fluorescence PCR)

As COVID-19 and influenza infections can hardly be differentiated based on symptoms, we developed the SARS-CoV-2 & Influenza A/B Detection Kit to provide the right diagnosis and best course of treatment for patients.

Consortium International additionally offers new state-of-the-art,  cost-effective and high performance SARS-CoV-2 + Influenza A/B Detection Kit (Fluorescence PCR) molecular diagnostic platform.

The SARS-CoV-2 & Influenza A/B Detection Kit (Direct Fluorescence PCR) is a rapid real-time RT-PCR test without RNA-purification intended for the simultaneous in vitro qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus nucleic acid in oropharyngeal swab and nasopharyngeal swab specimens from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar

 

As with our SARS-CoV-2 Detection Kit, our new SARS-CoV-2 & Influenza A/B Detection Kit is available under either the Healgen or the Orient Gene brand and also carries the European Union CE Mark, allowing their use in all countries adhering to the EU Declaration of Conformity. ​Our Healgen SARS-CoV-2 & Influenza A/B Detection Ki (Fluorescence PCR) molecular diagnostic platform is not being shipped internationally as will be available within the USA upon receiving the US FDA EUA which allows distribution and use within the USA.

 

Features & Benefits Specimen Type

 

• Simple operation - direct detection of

   samples without purification

• FAST - Sample to Result < One hour

• One Sample- 3 Targets

• Accurate differentiation of Covid-19,

   Influenza A and Influenza B

• Advanced separating technology applied

   to predispensed type of reagent

•Throat swab, nasal swab or sputum

Specimens can be read from a variety of existing PCR readers. However, we also offer two PCR readers, a portable reader as well as a lab based reader.

The SARS-CoV-2 & Influenza A/B Detection Kit (Direct Fluorescence PCR) is a rapid real-time RT-PCR test without RNA-purification intended for the simultaneous in vitro qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus nucleic acid in oropharyngeal swab and nasopharyngeal swab specimens from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.

Results are for the identification of SARS-CoV-2, influenza A and influenza B viral RNA, which is generally detectable in respiratory specimens (oropharyngeal swab and nasopharyngeal swab) during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2, influenza A or influenza B viral RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

Negative results do not preclude SARS-CoV-2, influenza A, and/or influenza B infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

The SARS-CoV-2 & Influenza A/B Detection Kit (Direct Fluorescence PCR) is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

 

[Test Principle]

This test a qualitative real-time fluorescent PCR that integrates nucleic acid release and RNA reverse transcription processes, which enables the direct amplification of SARS-CoV-2, Influenza A and/or influenza B RNA from oropharyngeal swab and nasopharyngeal swab specimens. Specific primers & probes are designed to detect the highly conservative regions of the ORF1ab and nucleocapsid protein (N) genes sequences of SARS-CoV-2, the matrix (M1) gene sequences of Influenza A and the nonstructural 2 (NS2) gene sequences of Influenza B. A pair of primers and a probe for detecting endogenous human RNase P gene are included as an internal amplification control to monitor the whole test process and control for inhibition. The specific probes of the SARS-CoV-2 & Influenza A/B gene are labeled with FAM (SARS-CoV-2), ROX (Influenza A) and VIC (Influenza B) respectively, and the probe of internal amplification control is labeled with CY5.

This product is intended for professional use and not for home use.

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