Product Comparison


 
Quidel M124
Roche 09211101190
BD 441124
BD 441126

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McKesson # 1177617 1177911 931480 931479 1174839
Description Reagent Kit Lyra® Molecular Diagnostic / Real Time RT-PCR Direct SARS-CoV-2 For use with Thermocycler 96 Tests Reagent Kit Cobas® Liat® Molecular Diagnostic / Real Time RT-PCR SARS-CoV-2 & Influenza A / B For use on the Cobas® Liat® System 20 tests Reagent Kit BD ProbeTec™ Amplified DNA Assay Neisseria Gonorrhoea For BD Viper™ Instrument 1,152 Tests 1,152 Tests Reagent Kit BD ProbeTec™ Infectious Disease Immunoassay Chlamydia Trachomatis / Neisseria Gohorrhoeae (CT / NG) For BD Viper™ Instrument 1,152 Tests 1,152 Tests Reagent Kit Aspartate Aminotransferase (AST) For use on the ACE Axcel and ACE Alera Clinical Chemistry Systems 450 Tests
Manufacturer # M12409211101190441124441126SA1053
Brand Lyra®Cobas® Liat®BD ProbeTec™BD ProbeTec™ 
Manufacturer QuidelRocheBDBDAlfa Wassermann
Invoice REAGENT, SARS COV-2 ASSAY W/CONTROLS (96/EA) D/SASSAY, SARS COV-2 FLU A/B COBAS LIAT (20TEST/KT)REAGENT KIT, PROBETEC DNA ASSAY GCREAGENT KIT, PROBETEC DNA ASSAY CTREAGENT, AST (450TEST/KT)
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Comparison

Container Type VialTube
Country of Origin United StatesGermanyUnknownUnknownUnited States
For Use With For use with ThermocyclerFor use on the Cobas® Liat® SystemFor BD Viper™ InstrumentFor BD Viper™ InstrumentFor use on the ACE Axcel and ACE Alera Clinical Chemistry Systems
Number of Tests 96 Tests20 Tests1,152 Tests1,152 Tests450 Tests
Product Dating McKesson Acceptable Dating: we will ship >= 90 daysMcKesson Acceptable Dating: we will ship >= 90 daysMcKesson Acceptable Dating: we will ship >= 30 daysMcKesson Acceptable Dating: we will ship >= 30 daysMcKesson Acceptable Dating: we will ship >= 90 days
Sample Type Nasal Swab / Nasopharyngeal Swab / Oropharyngeal Swab SampleNasal Swab / Nasopharyngeal Swab SampleUrine / Endocervical Swab / Vaginal Swab / Male Urethral Swab SamplesUrine / Endocervical Swab / Vaginal Swab / Male Urethral Swab Samples
Storage Requirements Requires RefrigerationRequires RefrigerationUSP Controlled Room TemperatureRequires Refrigeration
Test Name Direct SARS-CoV-2SARS-CoV-2 & Influenza A / BNeisseria GonorrhoeaChlamydia Trachomatis / Neisseria Gohorrhoeae (CT / NG)Aspartate Aminotransferase (AST)
Test Type Molecular Diagnostic / Real Time RT-PCRMolecular Diagnostic / Real Time RT-PCRAmplified DNA AssayInfectious Disease Immunoassay
Time To Results 70 Minute Results20 Minute Results
Type Amplified DNA Assay
UNSPSC Code 4111614441116144411160114111601141116105
Volume 1,152 Tests1,152 Tests
Application Reagent KitReagent KitReagent KitReagent KitReagent Kit
Features and Benefits
  • The Lyra® Direct SARS-CoV-2 Assay is for in vitro Diagnostic use under Emergency Use Authorization only: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
  • The Lyra® Direct SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasal (NS), nasopharyngeal (NP), or oropharyngeal (OP) direct swab specimens from individuals suspected of COVID-19 by their healthcare provider
  • Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests
  • Positive results do not rule out bacterial infection or co-infection with other viruses
  • Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
  • Negative results do not preclude SARS-CoV-2 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 Lyra Direct SARS-CoV-2 Assay 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
  • Rehydration solution is simply added to the lyophilized Master Mix
  • Results in less than 70 minutes after extraction
  • Simplified and uniform workflow with standard pipetting volumes
  • No ice or cooling block required
  • Kit includes Process Buffer, 12x8 Master Mix, Rehydration Solution and liquid Positive and Negative Controls
  • For use with Applied Biosystems 7500 Fast Dx, Applied Biosystems 7500 Standard, Roche LightCycler 480, Roche Cobas z480, Qiagen Rotor-Gene Q, Bio-Rad CFX96 Touch, Thermofisher QuantStudio 7 Pro Thermocyclers
  • The cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test is for use on the cobas Liat System under FDA Emergency Use Authorization: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
  • Emergency use of this test is limited to authorized laboratories: Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate or high complexity tests
  • The cobas SARS-CoV-2 & Influenza A/B Nucleic Acid Test for use on the cobas Liat System is also authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
  • The new cobas SARS-CoV-2 & Influenza A/B test analyzes nucleic acids from nasopharyngeal and nasal swab samples and self-collected nasal swabs (collected in a healthcare setting with instruction by a healthcare provider) to enable frontline healthcare workers to quickly identify and differentiate these similarly presenting infections
  • This test has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2, influenza A virus, and influenza B virus and not for any other viruses or pathogens
  • This test is only authorized in the United States for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner
  • Positive results are indicative of active infection but do not rule out bacterial infection or co-infection with other pathogens not detected by the test; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status
  • 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 diagnosis, treatment or other patient management decisions
  • Negative results must be combined with clinical observations, patient history, and/or epidemiological information
  • cobas® SARS-CoV-2 & Influenza A/B is intended for use by health professionals or trained operators who are proficient in using the cobas® Liat System
  • The cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System (cobas® SARS-CoV-2 & Influenza A/B) is an automated multiplex real-time RT-PCR assay intended for the simultaneous rapid in vitro qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B virus RNA
  • Contains sufficient reagents to process 20 specimens or quality control samples
  • Kit includes: 20 tests, 20 transfer pipettes, 1 package insert barcode card, cobas Liat Internal Process Control, Proteinase K, cobas Liat Magnetic Glass Particles, Lysis buffer, wash buffer, Elution buffer, A/B Master Mix 1, A/B Master Mix 2, A/B Master Mix 3
  • Qualitative detection of Neisseria gonorrhoeae DNA in clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens
  • Qualitative detection of Chlamydia trachomatis DNA in clinician-collected female endocervical and male urethral swab specimens, patient-collected vaginal swab specimens (in a clinical setting), and male and female urine specimens