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CERTEST BIOTEC

CERTEST BIOTEC

Certest Biotec, S.L. develops and manufactures IVD products in the human clinical testing field, including rapid tests. It offers a wide range of products for real time PCR that allow identification of causal pathogens causing infectious diseases and are suitable for use in physicians’ offices, laboratories and hospital ...
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Covid-19 CERTEST BIOTEC

Clinical Laboratory

SARS-CoV-2 Antigen Detection Plate
CerTest CLIA SARS-CoV-2 Plate

The CerTest CLIA SARS-CoV-2 Plate is an antigen detection product for the quantitative detection of SARS-CoV-2 antigen in human nasopharyngeal swabs specimens.
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SARS-CoV-2 (N1 + N2) RT PCR Test
VIASURE SARS-CoV-2 (N1 + N2) Real Time PCR Detection Kit

The VIASURE SARS-CoV-2 (N1 + N2) Real Time PCR Detection Kit for BD MAX System is an automated real-time RT-PCR test designed for the qualitative detection of RNA from the SARS-CoV-2 in respiratory samples from individuals suspected of COVID-19 by their healthcare provider. The test is intended to be used as an aid in the identification of the presence of the SARS-CoV-2 viral RNA. The assay uses the BD MAX™ System for automated extraction of RNA and subsequent real-time RT-PCR employing the reagents provided combined with universal reagents and disposables for the BD MAX System.
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SARS-CoV-2 Variant Detection Kit
VIASURE SARS-CoV-2 Variant I

VIASURE SARS-CoV-2 Variant I Real Time PCR Detection Kit is a real-time RT-PCR test designed for the qualitative detection of RNA from genetic mutations in the S gene (E484K, K417N, K417T and N501Y) from positive SARS-CoV-2 nasopharyngeal samples. This test is intended for use as an aid to monitor the prevalence of genetic mutations in the S gene (E484K, K417N, K417T and N501Y) and to assist in control measures.
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SARS-CoV-2 Variant Detection Kit
VIASURE SARS-CoV-2 Variant II

VIASURE SARS-CoV-2 Variant II Real Time PCR Detection Kit is a real-time RT-PCR test designed for the qualitative detection of RNA from genetic mutations in the S gene (P681R, L452R and E484Q) from positive SARS-CoV-2 nasopharyngeal samples. This test is intended for use as an aid to monitor the prevalence of genetic mutations in the S gene (P681R, L452R and E484Q) and to assist in control measures.
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SARS-CoV-2 One Step Card Test
CerTest SARS-CoV-2

The CerTest SARS-CoV-2 one step card test is a coloured chromatographic immunoassay for the qualitative detection of SARS-CoV-2 from nasopharyngeal swab samples from patients with sign and symptoms of COVID-19 infection. It offers a simple and a highly sensitive screening assay as an aid in the diagnosis of SARS-CoV-2 infection.
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SARS-CoV-2/Influenza A+B/RSV Combo One Step Card Test
CerTest SARS-CoV-2 + Flu A + Flu B + RSV

The CerTest SARS-CoV-2 + Flu A + Flu B + RSV one step combo card test is a coloured chromatographic immunoassay for the simultaneous qualitative detection of nucleoprotein antigen of SARS-CoV-2, Influenza type A, Influenza type B and Respiratory Syncytial Virus from nasopharyngeal swab samples from patients suspected of COVID-19 infection and/or Influenza A and/or Influenza B and/or Respiratory Syncytial Virus (RSV) infection. It offers a simple and highly sensitive screening assay as aid in the diagnosis of SARS-CoV-2 and/or Influenza type A and/or Influenza type B and/or RSV infection.
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SARS-CoV-2 Positive Control Kit
VIASURE Viral SARS-CoV-2 Positive Control Kit

The VIASURE Viral SARS-CoV-2 Positive Control Kit is intended for monitoring the whole reverse transcription quantitative real-time PCR (RT-qPCR) process, from nucleic acid extraction to reverse transcription and amplification steps. The kit contains non-replicative and non-infectious SARS-CoV-2 viral particles that are expected to be processed along with respiratory samples from individuals with clinical suspicion of COVID-19. It is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in molecular techniques and in vitro diagnostic procedures.
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SARS-CoV-2 & UK Variant RT-PCR Test
SARS-CoV-2 & UK Variant (S UK, ORF1ab and N genes)

The SARS-CoV-2 & UK Variant (S UK, ORF1ab and N genes) Real Time PCR Detection Kit is a real-time RT-PCR test designed for the qualitative detection of RNA from the SARS-CoV-2 and the HV 69/70 deletion of the S gene for SARS-CoV-2 associated to the SARS-CoV-2 VOC202012/01 (lineage B.1.1.7) variant and other variants in nasopharyngeal swabs from individuals suspected of COVID-19 infection by their healthcare professional (HCP). This test is intended for use as an aid in the diagnosis of SARS-CoV-2 as well as variants that carry the HV 69/70 deletion in combination with clinical and epidemiological risk factors.
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PCR Detection Kit
VIASURE MERS Coronavirus RT-PCR

The VIASURE MERS Coronavirus RT-PCR kit is designed for specific identification of MERS-CoV in clinical samples. The detection is done in a one-step real-time format where the reverse transcription and the subsequent amplification of specific target sequence occur in the same reaction well.
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PCR Detection Kit
VIASURE MERS Coronavirus

The VIASURE MERS Coronavirus real time PCR detection kit is designed for specific identification of MERS Coronavirus (MERS-CoV) in clinical samples from patients with signs and symptoms of MERS Coronavirus infection. The detection is done in a one-step real time RT format where the reverse transcription and the subsequent amplification of specific target sequence occur in the same reaction well.
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News of CERTEST BIOTEC

Certest Offers Sensitive, Useful and Cheap CE-IVD Multiplex Assay for Rapid Diagnosis of Atypical Pneumonia

15 Sep 2021
Certest Offers Sensitive, Useful and Cheap CE-IVD Multiplex Assay for Rapid Diagnosis of Atypical Pneumonia
CerTest Biotec (Zaragoza, Spain) has developed and validated the CE-IVD multiplex assay VIASURE C. pneumoniae, M. pneumoniae & L. pneumophila real time PCR kit for the detection of principal pathogens implicated in atypical pneumoniae.
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About CERTEST BIOTEC

Certest Biotec, S.L. develops and manufactures IVD products in the human clinical testing field, including rapid tests. It offers a wide range of products for real time PCR that allow identification of causal pathogens causing infectious diseases and are suitable for use in physicians’ offices, laboratories and hospitals.

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Real Time PCR Platform
VIASURE V-Lab96

The VIASURE V-Lab96 Real Time PCR Platform is an open platform for in vitro diagnostics that allows for the analysis of 96 samples simultaneously for qualitative and quantitative PCR. The combination of a fast and uniform heating, high sensitivity optical system and an easy-to-use software provides a great advantage for users.
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SARS-CoV-2 Antigen Detection Plate
CerTest CLIA SARS-CoV-2 Plate

The CerTest CLIA SARS-CoV-2 Plate is an antigen detection product for the quantitative detection of SARS-CoV-2 antigen in human nasopharyngeal swabs specimens.
More details

ZIKV/DENV/CHIKV/WNV/YFV/MYV Test
VIASURE Tropical Panel I Real Time PCR Detection Kit

VIASURE Tropical Panel I Real Time PCR Detection Kit is designed for the specific and differentiation of Zika (ZIKV), Dengue (DENV), Chikungunya (CHIKV), West Nile (WNV), Yellow fever (YFV) and/or Mayaro (MYV) viruses in clinical samples from patients with signs and symptoms of Zika, Dengue, Chikungunya, West Nile, Yellow fever and/or Mayaro viruses infection. This test is intended for use as an aid in the diagnosis of the ZIKV, DENV, CHIKV, WNV, YFV and MAV in combination with clinical and epidemiological risk factors. RNA is extracted from specimens, amplified using RT-PCR and detected using fluorescent reporter dye probes specific for Zika, Dengue, Chikungunya, West Nile, Yellow fever, and Mayaro viruses.
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Clinical Laboratory

Real Time PCR Platform
VIASURE V-Lab96

The VIASURE V-Lab96 Real Time PCR Platform is an open platform for in vitro diagnostics that allows for the analysis of 96 samples simultaneously for qualitative and quantitative PCR. The combination of a fast and uniform heating, high sensitivity optical system and an easy-to-use software provides a great advantage for users.
More details

SARS-CoV-2 Antigen Detection Plate
CerTest CLIA SARS-CoV-2 Plate

The CerTest CLIA SARS-CoV-2 Plate is an antigen detection product for the quantitative detection of SARS-CoV-2 antigen in human nasopharyngeal swabs specimens.
More details

ZIKV/DENV/CHIKV/WNV/YFV/MYV Test
VIASURE Tropical Panel I Real Time PCR Detection Kit

VIASURE Tropical Panel I Real Time PCR Detection Kit is designed for the specific and differentiation of Zika (ZIKV), Dengue (DENV), Chikungunya (CHIKV), West Nile (WNV), Yellow fever (YFV) and/or Mayaro (MYV) viruses in clinical samples from patients with signs and symptoms of Zika, Dengue, Chikungunya, West Nile, Yellow fever and/or Mayaro viruses infection. This test is intended for use as an aid in the diagnosis of the ZIKV, DENV, CHIKV, WNV, YFV and MAV in combination with clinical and epidemiological risk factors. RNA is extracted from specimens, amplified using RT-PCR and detected using fluorescent reporter dye probes specific for Zika, Dengue, Chikungunya, West Nile, Yellow fever, and Mayaro viruses.
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Celiac Real Time PCR Detection Kit
VIASURE HLA Celiac Real Time PCR Detection Kit

The VIASURE HLA Celiac Real Time PCR Detection Kit is a simple and ready to use real-time PCR for the detection of the principal alleles of the HLA system and the subsequent determination of the DQ2 and DQ8 antigens associated with Celiac disease (CD). The kit detects the alleles DQA105, DQB10302, DQB102, DQA102, DQA103 and NO DQB102 in blood samples. DNA is extracted from blood specimens, multiplied using Real Time amplification and detected using specific primers and a fluorescent reporter dye probe for HLA alleles. Notably, thanks to the product's design and its lyophilized format, handling is minimal and easier than similar molecular assays. These characteristics help the process to be faster, being able to obtain the results and therefore, the clinical diagnosis time in approximately two hours.
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Methicillin-Resistant Staphylococcus Aureus RT PCR Test
VIASURE Methicillin-Resistant Staphylococcus Aureus Real Time PCR Detection Kit

The VIASURE Methicillin-resistant Staphylococcus aureus Real Time PCR Detection Kit is designed for the specific identification and differentiation methicillin-resistant Staphylococcus aureus (MRSA), methicillin-sensitive Staphylococcus aureus (MSSA) and/or methicillin-resistant coagulase-negative Staphylococci (MRCoNS) from isolated colonies from human nasal, pharyngeal and perianal swabs plated onto chromogenic solid medium. The test is intended to be used as an aid in the diagnosis of MRSA infection in combination with patient’s clinical signs and symptoms and epidemiological risk factors.
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C. pneumoniae, M. pneumoniae & L. pneumophila RT PCR Test
VIASURE C. pneumoniae, M. pneumoniae & L. pneumophila Real Time PCR Detection Kit

The VIASURE C. pneumoniae, M. pneumoniae & L. pneumophila Real Time PCR Detection Kit is designed for specific identification and differentiation of human Chlamydophila pneumoniae, Mycoplasma pneumoniae and Legionella pneumophila in clinical samples from patients with signs and symptoms of respiratory infection. The test is intended for use as an aid in the diagnosis of Chlamydophila pneumoniae, Mycoplasma pneumoniae and/or Legionella pneumophila in combination with clinical and epidemiological risk factors.
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SARS-CoV-2 (N1 + N2) RT PCR Test
VIASURE SARS-CoV-2 (N1 + N2) Real Time PCR Detection Kit

The VIASURE SARS-CoV-2 (N1 + N2) Real Time PCR Detection Kit for BD MAX System is an automated real-time RT-PCR test designed for the qualitative detection of RNA from the SARS-CoV-2 in respiratory samples from individuals suspected of COVID-19 by their healthcare provider. The test is intended to be used as an aid in the identification of the presence of the SARS-CoV-2 viral RNA. The assay uses the BD MAX™ System for automated extraction of RNA and subsequent real-time RT-PCR employing the reagents provided combined with universal reagents and disposables for the BD MAX System.
More details

SARS-CoV-2 Variant Detection Kit
VIASURE SARS-CoV-2 Variant II

VIASURE SARS-CoV-2 Variant II Real Time PCR Detection Kit is a real-time RT-PCR test designed for the qualitative detection of RNA from genetic mutations in the S gene (P681R, L452R and E484Q) from positive SARS-CoV-2 nasopharyngeal samples. This test is intended for use as an aid to monitor the prevalence of genetic mutations in the S gene (P681R, L452R and E484Q) and to assist in control measures.
More details

SARS-CoV-2 Variant Detection Kit
VIASURE SARS-CoV-2 Variant I

VIASURE SARS-CoV-2 Variant I Real Time PCR Detection Kit is a real-time RT-PCR test designed for the qualitative detection of RNA from genetic mutations in the S gene (E484K, K417N, K417T and N501Y) from positive SARS-CoV-2 nasopharyngeal samples. This test is intended for use as an aid to monitor the prevalence of genetic mutations in the S gene (E484K, K417N, K417T and N501Y) and to assist in control measures.
More details

SARS-CoV-2 & UK Variant RT-PCR Test
SARS-CoV-2 & UK Variant (S UK, ORF1ab and N genes)

The SARS-CoV-2 & UK Variant (S UK, ORF1ab and N genes) Real Time PCR Detection Kit is a real-time RT-PCR test designed for the qualitative detection of RNA from the SARS-CoV-2 and the HV 69/70 deletion of the S gene for SARS-CoV-2 associated to the SARS-CoV-2 VOC202012/01 (lineage B.1.1.7) variant and other variants in nasopharyngeal swabs from individuals suspected of COVID-19 infection by their healthcare professional (HCP). This test is intended for use as an aid in the diagnosis of SARS-CoV-2 as well as variants that carry the HV 69/70 deletion in combination with clinical and epidemiological risk factors.
More details

SARS-CoV-2 Positive Control Kit
VIASURE Viral SARS-CoV-2 Positive Control Kit

The VIASURE Viral SARS-CoV-2 Positive Control Kit is intended for monitoring the whole reverse transcription quantitative real-time PCR (RT-qPCR) process, from nucleic acid extraction to reverse transcription and amplification steps. The kit contains non-replicative and non-infectious SARS-CoV-2 viral particles that are expected to be processed along with respiratory samples from individuals with clinical suspicion of COVID-19. It is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in molecular techniques and in vitro diagnostic procedures.
More details

SARS-CoV-2/Influenza A+B/RSV Combo One Step Card Test
CerTest SARS-CoV-2 + Flu A + Flu B + RSV

The CerTest SARS-CoV-2 + Flu A + Flu B + RSV one step combo card test is a coloured chromatographic immunoassay for the simultaneous qualitative detection of nucleoprotein antigen of SARS-CoV-2, Influenza type A, Influenza type B and Respiratory Syncytial Virus from nasopharyngeal swab samples from patients suspected of COVID-19 infection and/or Influenza A and/or Influenza B and/or Respiratory Syncytial Virus (RSV) infection. It offers a simple and highly sensitive screening assay as aid in the diagnosis of SARS-CoV-2 and/or Influenza type A and/or Influenza type B and/or RSV infection.
More details

SARS-CoV-2 One Step Card Test
CerTest SARS-CoV-2

The CerTest SARS-CoV-2 one step card test is a coloured chromatographic immunoassay for the qualitative detection of SARS-CoV-2 from nasopharyngeal swab samples from patients with sign and symptoms of COVID-19 infection. It offers a simple and a highly sensitive screening assay as an aid in the diagnosis of SARS-CoV-2 infection.
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Respiratory Test Kit
VIASURE Respiratory Panel IV

The VIASURE Respiratory Panel IV Real Time PCR Detection Kit is intended for use as an aid in the diagnosis of Flu A and/or B; Influenza A H1N1)2009; RSV A and/or B; Parainfluenzas viruses; AdV, MPV and/or BoV, HRV and/or HEV; CoV 229E, NL63, OC43 and/or HKU1 strains in combination with clinical and epidemiological risk factors. The RNA/DNA is extracted from clinical specimens, multiplied using Real Time amplification and detected using specific primers and a fluorescent reporter dye probe.
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Streptococcal Test
CerTest Strep A

The CerTest Strep A one step card test is a colored chromatographic immunoassay for the qualitative detection of Group A Streptococcal from throat swabs and suspected Group A Streptococcal colonies recovered from culture. It offers a simple and highly sensitive screening assay to make a presumptive diagnosis of Group A Streptococcal respiratory infection.
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Adenovirus Test
CerTest Adenovirus Resp.

The CerTest Adenovirus Resp. one step card test is a colored chromatographic immunoassay for the qualitative detection of Adenovirus from nasal swab, nasopharyngeal wash or aspirate specimens. It offers a simple and a highly sensitive screening assay to make a presumptive diagnosis of Adenovirus respiratory infection.
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Immunoassay Test
CerTest Legionella

The CerTest Legionella is a colored chromatographic immunoassay for the qualitative detection of Legionella pneumophila serogroup 1 in human urine samples. It offers a highly sensitive and simple screening assay to make a presumptive diagnosis of legionelosis in infected humans with a time to result of 15 minutes.
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Quantitative Aassay
CerTest FOB Turbilatex

The CerTest FOB Turbilatex is a quantitative assay that offers a simple, a highly sensitive and non-invasive screening assay to make a presumptive diagnosis of gastrointestinal bleeding. It detects intact or nearly intact human hemoglobin, being a very specific technique for detecting loss of blood from the lower intestine.
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Rapid Test
VIASURE Gastrointestinal Panel I

The VIASURE Gastrointestinal Panel I is designed for the specific identification and differentiation of Salmonella, Campylobacter and/or Yersinia enterocolitica; Shigella/EIEC; Cryptosporidium, Giardia lamblia and/or Entamoeba histolytica; Norovirus GI and/or Norovirus GII (NoV); Rotavirus (RV); Adenovirus (AdV); Astrovirus (AstV); and/or Sapovirus (SaV) in human stool samples from patients with signs and symptoms of gastrointestinal infection. It is intended for use as an aid in the diagnosis of Salmonella, Campylobacter and/or Y. enterocolitica; Shigella/EIEC; Cryptosporidium, G. lamblia and/or E. histolytica; NoV GI and/or NoV GII; RV; AdV; AstV; and/or SaV infection in combination with clinical and epidemiological risk factors.
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Combo Immunoassay Test
Influenza A + Influenza B + RSV + Adenovirus Resp.

The Influenza A + Influenza B + RSV + Adenovirus Resp. one step combo card test is a colored chromatographic immunoassay for the simultaneous qualitative detection of Influenza type A and type B, Respiratory Syncytial Virus and Adenovirus antigens from nasopharyngeal swab, nasopharyngeal wash or aspirate specimens. It is a simple and a highly sensitive screening assay to make a presumptive diagnosis of Influenza type A and B, Respiratory Syncytial Virus and/or Adenovirus respiratory infection.
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Real PCR Detection Kit
VIASURE Flu Typing I

The VIASURE Flu Typing I Real PCR Detection Kit is designed for the specific identification and differentiation of Influenza A (H1N1)pdm09 and H3N2 subtypes in respiratory samples from patients with signs and symptoms of respiratory infection. The RNA is extracted from specimens, amplified using RT-PCR and detected using fluorescent reporter dye probes specific for Influenza A (H1N1)pdm09 and H3N2 subtypes.
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PCR Detection Kit
VIASURE MERS Coronavirus RT-PCR

The VIASURE MERS Coronavirus RT-PCR kit is designed for specific identification of MERS-CoV in clinical samples. The detection is done in a one-step real-time format where the reverse transcription and the subsequent amplification of specific target sequence occur in the same reaction well.
More details

PCR Detection Kit
VIASURE MERS Coronavirus

The VIASURE MERS Coronavirus real time PCR detection kit is designed for specific identification of MERS Coronavirus (MERS-CoV) in clinical samples from patients with signs and symptoms of MERS Coronavirus infection. The detection is done in a one-step real time RT format where the reverse transcription and the subsequent amplification of specific target sequence occur in the same reaction well.
More details

Immunoassay Test
CerTest S. pneumoniae + Legionella

The CerTest S. pneumoniae + Legionella one-step combo card test is a colored chromatographic immunoassay for the simultaneous qualitative detection of Streptococcus pneumoniae and Legionella pneumophila serogroup 1 in human urine samples. The rapid test delivers results in 15 minutes using a urine specimen, which is convenient for collection, transport, and subsequent detection of early, as well as later, stages of disease.
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PCR Detection Kit
VIASURE

The VIASURE kit is designed for specific detection and differentiation of Zika, Dengue and/or Chikungunya viruses in samples from patients with signs/symptoms of infection. The test is intended for use as an aid in diagnosis, in combination with clinical and epidemiological risk factors.
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