Serology testing was performed by the Abbott ARCHITECT i1000 instrument using the Abbott SARS-CoV-2 IgG and the AdviseDx SARS-CoV-2 IgM assays (Abbott Park, IL). Both assays are chemiluminescent microparticle immunoassays that give a qualitative result of “Positive” or “Negative” based on a numerical index value and a cutoff based on the sample result divided by calibrator result (S/C). The IgG assay targets the nucleocapsid protein and has a cutoff value of 1.4. The IgG assay was authorized by the FDA under Emergency Use Authorization (EUA) in April 2020. The IgM assay targets the spike protein and has a cutoff value of 1.0 and was authorized by the FDA under an EUA in October 2020. Nucleic Acid Amplification Test (NAAT) detection of SARS-CoV-2 from nasopharyngeal swabs was performed using the Simplexa COVID-19 Direct assay on the Diasorin Liason MDX thermocycler system (Cypress, CA) targeting the ORF1ab and S genes, for the majority of samples. An alternate assay was used for 2 of the NAAT positives: the Hologic Aptima SARS-CoV-2 (Marlborough, MA) assay targeting the ORF1ab gene.
Simplexa covid 19 direct assay
Manufactured by DiaSorin
Sourced in Italy, France
The Simplexa COVID-19 Direct assay is a laboratory diagnostic product designed to detect the presence of the SARS-CoV-2 virus, the causative agent of COVID-19. The assay utilizes a direct molecular testing approach, allowing for the detection of the virus without the need for RNA extraction. This streamlined process can provide results more efficiently.
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Lab products found in correlation
Cobas sars cov 2 assay, by Roche (3 mentions)
Alinity m sars cov 2 assay, by Abbott (2 mentions)
Neumodx sars cov 2 assay, by Qiagen (2 mentions)
Xpert xpress sars cov 2 assay, by Cepheid (2 mentions)
Architect i1000, by Abbott (1 mentions)
Sars cov 2 igg, by Abbott (1 mentions)
Id now covid 19 assay, by Abbott (1 mentions)
Liaison mdx, by DiaSorin (1 mentions)
Liaison mdx instrument, by DiaSorin (1 mentions)
8 protocols using simplexa covid 19 direct assay
1
SARS-CoV-2 Serology and NAAT Testing
2
Comparison of ID NOW and Simplexa COVID-19 Assays
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The ID NOW COVID-19 assay (Abbott, Chicago, Il, USA) is an isothermal nucleic acid amplification-based. The assay was performed directly from the dry swab in the ED or by transferring 200 microliters of VTM to elution buffer in the sample base and then mixed for 10 seconds per instructions for use at the microbiology laboratory.
The Simplexa COVID-19 direct assay (Diasorin, Saluggia, Italy) was chosen as RT-PCR reference test and was performed with the DiaSorin LIAISON® MDX according to the manufacturer's instructions for use. A 50 μl volume of Simplexa COVID-19 Direct kit reaction mix (MOL415 0) was added to the “R” well of the 8-well direct amplification disc followed by addition of 50 μl of non extracted nasopharyngeal swab sample to the “SAMPLE” well. Fluorescent probes are used together with corresponding forward and reverse primers to amplify two different regions of the SARS-CoV-2 genome: ORF1ab and S gene. Data collection and analysis were performed with LIAISON® MDX Studio software. CT values were collected from MDX software.
The Simplexa COVID-19 direct assay (Diasorin, Saluggia, Italy) was chosen as RT-PCR reference test and was performed with the DiaSorin LIAISON® MDX according to the manufacturer's instructions for use. A 50 μl volume of Simplexa COVID-19 Direct kit reaction mix (MOL415 0) was added to the “R” well of the 8-well direct amplification disc followed by addition of 50 μl of non extracted nasopharyngeal swab sample to the “SAMPLE” well. Fluorescent probes are used together with corresponding forward and reverse primers to amplify two different regions of the SARS-CoV-2 genome: ORF1ab and S gene. Data collection and analysis were performed with LIAISON® MDX Studio software. CT values were collected from MDX software.
3
SARS-CoV-2 Detection by RT-PCR Assays
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NPS were collected by a health care professional and were placed directly onto a viral transport medium before transport to the laboratory. Fresh, self-collected saliva were transported to the laboratory without any viral transport media and were then diluted in phosphate-buffered saline (PBS) and lysis buffer before amplification (5 (link)).
Molecular detection was based on the RT-PCR amplification of at least two viral genome regions. The assays used by our laboratory during the study period were the Cobas SARS-CoV-2 assay (“ROC”, Roche Molecular Diagnostics, Mannheim, Germany), Alinity m SARS-CoV-2 assay (“ALI”, Abbott Molecular, Rungis, France), NeuMoDx SARS-CoV-2 assay (“NMDx”, Qiagen, Courtaboeuf, France), Xpert Xpress SARS-CoV-2 assay (“CPH”, Cepheid, Maurens-Scopont, France), and Simplexa COVID-19 Direct assay (“SPX”, DiaSorin, Antony, France).
Our laboratory information system collected results expressed as cycle threshold (Ct) values. For assays with multiple targets, the mean Ct value was calculated.
Molecular detection was based on the RT-PCR amplification of at least two viral genome regions. The assays used by our laboratory during the study period were the Cobas SARS-CoV-2 assay (“ROC”, Roche Molecular Diagnostics, Mannheim, Germany), Alinity m SARS-CoV-2 assay (“ALI”, Abbott Molecular, Rungis, France), NeuMoDx SARS-CoV-2 assay (“NMDx”, Qiagen, Courtaboeuf, France), Xpert Xpress SARS-CoV-2 assay (“CPH”, Cepheid, Maurens-Scopont, France), and Simplexa COVID-19 Direct assay (“SPX”, DiaSorin, Antony, France).
Our laboratory information system collected results expressed as cycle threshold (Ct) values. For assays with multiple targets, the mean Ct value was calculated.
4
SARS-CoV-2 Detection by RT-PCR Assays
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NPS were collected by a health care professional and were placed directly onto a viral transport medium before transport to the laboratory. Fresh, self-collected saliva were transported to the laboratory without any viral transport media and were then diluted in phosphate-buffered saline (PBS) and lysis buffer before amplification (5 (link)).
Molecular detection was based on the RT-PCR amplification of at least two viral genome regions. The assays used by our laboratory during the study period were the Cobas SARS-CoV-2 assay (“ROC”, Roche Molecular Diagnostics, Mannheim, Germany), Alinity m SARS-CoV-2 assay (“ALI”, Abbott Molecular, Rungis, France), NeuMoDx SARS-CoV-2 assay (“NMDx”, Qiagen, Courtaboeuf, France), Xpert Xpress SARS-CoV-2 assay (“CPH”, Cepheid, Maurens-Scopont, France), and Simplexa COVID-19 Direct assay (“SPX”, DiaSorin, Antony, France).
Our laboratory information system collected results expressed as cycle threshold (Ct) values. For assays with multiple targets, the mean Ct value was calculated.
Molecular detection was based on the RT-PCR amplification of at least two viral genome regions. The assays used by our laboratory during the study period were the Cobas SARS-CoV-2 assay (“ROC”, Roche Molecular Diagnostics, Mannheim, Germany), Alinity m SARS-CoV-2 assay (“ALI”, Abbott Molecular, Rungis, France), NeuMoDx SARS-CoV-2 assay (“NMDx”, Qiagen, Courtaboeuf, France), Xpert Xpress SARS-CoV-2 assay (“CPH”, Cepheid, Maurens-Scopont, France), and Simplexa COVID-19 Direct assay (“SPX”, DiaSorin, Antony, France).
Our laboratory information system collected results expressed as cycle threshold (Ct) values. For assays with multiple targets, the mean Ct value was calculated.
5
Comparative COVID-19 Detection by PCR
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PCR was performed on nasal swabs with the Alinity kit (Abbott). PCR was performed on blood with the SIMPLEXA COVID-19 direct assay (DiaSorin).
6
SARS-CoV-2 Direct RT-PCR Assay Validation
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The Simplexa COVID-19 Direct assay (DiaSorin Molecular, Cypress, CA) was performed according to the manufacturer's instructions for use. Briefly, 50 μL of Simplexa COVID-19 Direct Kit reaction mix (MOL4150) was added to the “R” well of the 8-well Direct Amplification Disc (DAD) followed by adding 50 μL of non-extracted oropharyngeal swab sample (collected in approximately 3 mL of UVT (UVT, BD)) to the “SAMPLE” well. Tests were run on the LIAISON MDX system, and data collection and analysis were performed with LIAISON MDX Studio software. The assay targets two different regions of the SARS-CoV-2 genome, the S gene, and ORF1ab, differentiated with FAM and JOE fluorescent probes. An RNA internal control (Q670 probe) is used to detect RT-PCR failure and or inhibition. The result interpretation algorithm for reporting a positive specimen requires only one of the two targets to be detected (S or ORF1ab gene). The oropharyngeal specimen is off-label for DiaSorin Molecular, but proper validation was conducted and published previously by the OhioHealth Laboratory Services (Cradic et al., 2020 (link)).
7
Evaluating Roche Cobas SARS-CoV-2 Assay
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Assay performance was evaluated using a total of 253 oropharyngeal specimens originally submitted for routine COVID-19 testing at OhioHealth Riverside Methodist Hospital on the Roche Cobas SARS-CoV-2 assay. Positive and negative specimens were selected during the submission process for EUA approval of the Roche assay for use in asymptomatic patients. Samples were thawed and subsequently tested on the DiaSorin Molecular Simplexa COVID-19 Direct assay. The study population included patients 4-85 years of age and both genders and were selected based on the patient's status (asymptomatic individual reported on the order entry questions).
8
COVID-19 Viral RNA Quantification
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The viral RNA present in the culture medium of the samples described above were quantified by Ct measurement with Simplexa™ COVID-19 Direct assay (DiaSorin, Vicenza, Italy), as previously described [29 (link)] according to the manufacturer’s instructions. Briefly, 50 μL of culture medium and 50 μL of Reaction Mix were added to their specific wells on a direct amplification disk, which was loaded onto the LIAISON® MDX instrument (DiaSorin).
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