Roche 8800

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Regenia Junke

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Aug 3, 2024, 5:11:24 PM8/3/24

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As healthcare shifts from volume to value, the cobas 8800 System can help you elevate the value your laboratory provides your organisation. As of August 2020, more than 2000 cobas 6800 and cobas 8800 Systems have been installed globally, helping laboratories automate, consolidate, integrate and standardise molecular testing like never before.

Deliver trusted, reproducible results while rapidly completing your daily testing requirements. The cobas 8800 System can run up to 96 results in about 3 hours* and up to 1,824 results from an 8 hour shift.

The cobas omni Utility Channel allows you to broaden your menu and achieve greater testing flexibility. This dedicated open channels brings the workflow efficiencies of IVD test to high-volume laboratory developed tests (LDTs) and third party assays, standardising workflows and minimising the opportunity for error.

The cobas 8800 System is designed to meet the ever-changing needs of your laboratory and your organisation. The broad on-demand assay menu delivers reliable results across a wide range of applications, making test consolidation easy and effective.

The cobas 8800 System can be linked to pre- and post-analytical solutions, connected across disciplines, and enhanced with cutting-edge data solutions. The Molecular Work Area is truly in a class of its own.

Roche Healthcare Consulting gives you access to our world-class service team, comprised of more than 2,000 technical and field experts in more than 70 countries. Roche introduced the world to PCR and is committed to driving laboratory innovation into the future.

As healthcare shifts from volume to value, the cobas 8800 System can help you elevate the value your laboratory provides your organization. Since 2014, more than 1000 cobas 6800 and cobas 8800 Systems have been installed on five continents, helping laboratories automate, consolidate, integrate and standardize molecular testing like never before.

The cobas omni Utility Channel allows you to broaden your menu and achieve greater testing flexibility. This dedicated open channels brings the workflow efficiencies of IVD test to high-volume laboratory developed tests (LDTs) and third party assays, standardizing workflows and minimizing the opportunity for error.

The cobas 8800 System is designed to meet the ever-changing needs of your laboratory and your organization. The broad on-demand assay menu delivers reliable results across a wide range of applications, making test consolidation easy and effective.

The cobas 8800 System can help you meet the growing needs of your lab with highly efficient workflows, from sample processing to result interpretation. Deliver trusted, reproducible results while rapidly completing your daily testing requirements.

This test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acids from SARS-CoV-2, influenza A virus, and influenza B virus, and not for any other viruses or pathogens; and

This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Act, 21 U.S.C. 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner.

Roche has been pioneering innovation in molecular testing for decades and remains committed to supporting laboratories in meeting both their own needs and the needs of the patients everywhere.

Speak with your Roche representative to learn more

The cobas SARS-CoV-2 Test provides reliable and high-quality results for clinical decision-making for patients with suspected COVID-19 (coronavirus) infection. The cobas SARS-CoV-2 Test is a qualitative assay that allows the detection of nucleic acids in samples from patients who meet COVID-19 (coronavirus) clinical and/or epidemiological criteria. The tests are for use on the automated, high throughput cobas 6800/8800 Systems under Emergency Use Authorization.

The cobas SARS-CoV-2 Test is a single-well dual target assay, which includes both specific detection of SARS-CoV-2 (COVID-19 Coronavirus) and pan-sarbecovirus detection for the sarbecovirus subgenus family that includes SARS-CoV-2. The assay has a full-process negative control, positive control and internal control.

Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). The novel coronavirus (SARS-CoV-2, also known as COVID-19) is a new strain which has not previously been identified in humans.

Signs of infection include respiratory symptoms such as cough, shortness of breath, difficulty breathing and fever. In more severe cases, pneumonia, severe acute respiratory syndrome, kidney failure and death can occur.

To control the spread of the infection, WHO recommends vaccination, social distancing, wearing masks when distancing is not possible, regular hand washing and avoiding close contacts with anyone showing symptoms of respiratory illness.

cobas SARS-CoV-2 for use on the cobas 6800/8800 Systems is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 inhealthcareprovider-instructed self-collectedanteriornasal(nasal)swab specimens (collectedon site), andhealthcare provider-collectednasal,nasopharyngeal, and oropharyngealswab specimenscollectedfromanyindividuals, including those suspected of COVID-19 by their healthcare provider,and those without symptoms or other reasons to suspect COVID-19. cobas SARS-CoV-2 is for use only under Emergency Use Authorization (EUA)in laboratoriescertified underClinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements toperform high or moderatecomplexity tests.

This test is also intended for the qualitative detection of nucleic acids from SARS-CoV-2 in pooled samples containing up to and including six individual samples fromhealthcare provider-instructed self-collected nasal swab specimens (collected on site), or healthcare provider-collected nasal, nasopharyngeal, and oropharyngeal swab specimens. Negative results from pooled samples should be treated as presumptive and, if inconsistent with clinical signs and symptoms or necessary for patient management,pooled samples should be tested individually.Specimens included in pools with a positive or presumptive positive result must be tested individually prior to reporting a result. Specimens with low SARS-CoV-2 RNA concentrations may not be detected in sample pools due to the decreased sensitivity of pooled testing. Testing of pooled samples is limited to laboratories certified under CLIA, 42 U.S.C. 263a, that meet requirements to perform high complexity tests.

Results are for the detection of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable inrespiratoryspecimens duringthe acute phase ofinfection.Positive results are indicative of the presence of SARS-CoV-2 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.

In the United States:
- This test has not been FDA cleared or approved;
- This test has been authorized by FDA under an EUA for use by authorized laboratories;
- This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization
of the emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Act, 21 U.S.C. 360bbb- 3(b)(1), unless the authorization is terminated or revoked sooner

Basel, 21 April 2020 - Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced US Food and Drug Administration (FDA) approval for the cobas HPV test for use on the fully automated, high-throughput cobas 6800/8800 Systems. The cobas HPV test identifies women at risk for cervical cancer by detecting the presence of high-risk human papillomavirus (HPV) DNA in cervical samples. Persistent high-risk HPV infections can develop into precancerous lesions and, if left untreated, these lesions can progress to cervical cancer.

The goal of cervical cancer screening is to find and treat precancer early to help stop the progression of disease. The cobas HPV test helps to protect women from the potential harms of undetected and untreated cervical disease by detecting the virus that causes nearly all cervical cancers.

The cobas HPV test, previously approved for the cobas 4800 System, is now part of the growing menu of clinically validated, FDA approved tests for use on cobas 6800/8800 Systems. Laboratories now have the ability to run HPV DNA tests simultaneously with other previously released cobas tests on these high-throughput systems.