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COVID-19 Saliva Dx Test Kit

COVID-19 Saliva Dx Test Kit

$0.00

100 tests/kit


Highlights


  • Validated for saliva samples which are non-invasive, easy-to-collect, and safe
  • Low-cost, two-step direct viral RNA extraction that eliminates the purification step
  • High-throughput with 60 minutes PCR run time and minimal hands-on time

Description


The COVID-19 Saliva Dx Test Kit is a reverse transcription-quantitative PCR (RT-qPCR) in vitro diagnostic test for the qualitative detection of RNA from SARS-CoV-2 in saliva specimens and others. Go from sample to result in two hours. RNA is extracted in two simple steps, eliminating traditional purification steps.

An Assay Designed For Saliva


Saliva is a specimen that is increasing in popularity due to its non-invasive, simple, and safe format. Patients can reliably self-collect samples, minimizing risk of viral exposure to health personnel. The easy-to-perform method also reduces errors made in more complicated sampling procedures, which lead to false negatives or costly repeat testing.

Saliva and nasopharyngeal swabs in VTM have demonstrated equivalence in the validation study. Other studies have found saliva as sensitive, if not more, than nasopharyngeal swabs for COVID detection. The assay can also accommodate nasopharyngeal, nasal, and mid-turbinate swab specimens, giving you and your customers flexible testing options.

Questions about COVID-19 diagnostic testing?

Talk to a Specialist

Low-cost, High-throughput Viral RNA Extraction


The Enzymatic DNA/RNA Extraction Buffer 10X is a low-cost, high-throughput extraction method that has been validated for use with the COVID-19 Saliva Dx Test Kit and removes the need for expensive and manually-intensive RNA purification steps. More samples can be processed in one day due to the minimal hands-on time. The cost per extraction comes to $1/sample, making it an economical choice.

Lab professionals can process samples safely as the virus is immediately inactivated by the addition of the extraction buffer.

Quick Start Bundle


Chai’s COVID-19 Saliva Dx Quick Start Bundle
Contains everything you need to begin diagnostic testing for COVID today:


Supplies

COVID-19 Saliva Dx Test Kit for 100 tests

Enzymatic DNA/RNA Extraction Buffer 10X

Filter tips for 10 μL, 100 μL and 1000 μL pipettes

PCR tube & cap strips

1.5 mL microcentrifuge tubes

What's covered?
Add to Cart $11,200

Intended Use


The Chai COVID-19 Saliva Dx Test Kit is a RT-qPCR test intended for the qualitative detection of the SARSCoV-2 virus in upper and lower respiratory specimens including nasopharyngeal swab in viral transport media (VTM), and saliva specimens collected without preservatives in a sterile container. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.

Results are for the identification of SARS-CoV-2 RNA, which is generally detectable in respiratory specimens during the acute phase of infection. Positive results indicate the presence of SARS-CoV-2 RNA. 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. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. Negative results indicate that the amount of SARS-CoV-2 present in the initial sample is lower than the limit of detection.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for public health decisions. Negative results should be combined with patient history, clinical observations and epidemiological information.

The COVID-19 Saliva Dx Test Kit is intended for use by qualified laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Chai COVID-19 Saliva Dx Test Kit has been validated by Chai pursuant to the FDA Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. FDA’s independent review of this validation is pending.

Technical Specifications


Limit of Detection5.8 viral copies/µL
Specimen TypesSaliva, nasopharyngeal swabs
Specimen Storage ConditionsUp to 16 hours at ambient
Up to 72 hours at 4 ˚C
Reagent Storage Conditions-30 ºC to -10 ºC
InclusivitySARS-CoV-2
Detection ChannelsFAM, HEX
Endogenous ControlRPLP0
Positive ControlHuman RPLP0 and SARS-CoV-2 N gene fragments
UNG Carry-over PreventionIncluded
Extraction MethodEnzymatic DNA/RNA Extraction Buffer 10X
Validated InstrumentsOpen qPCR dual channel
Bio-Rad CFX96 Touch

Kit Components


ComponentAmount
COVID-19 Saliva Dx RT-qPCR Master Mix1.1 mL
COVID-19 Saliva Dx Oligo Mix415 µL
COVID-19 Saliva Dx Cofactor Buffer415 µL
COVID-19 Saliva Dx Positive Control110 µL
DNase/RNase-Free Water500 µL

Questions about COVID-19 diagnostic testing?

Talk to a Specialist

FAQs


  • Can the test kit be used on other Real-Time PCR instruments?

    The COVID-19 Saliva Dx Test Kit has been validated on the Chai Open qPCR dual channel and Bio-Rad CFX96 Touch instruments. The kit utilizes FAM and HEX fluorophores for detection.

    The FDA has published guidance for CLIA laboratories wishing to modify the test for use on other instruments, including a suggested bridging study. Details can be found in FDA’s Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.

  • What specimens can be tested?
    The COVID-19 Saliva Dx Test Kit is validated for saliva specimens, as well as nasal, mid-turbinate, and nasopharyngeal swabs in VTM media. Saliva specimens should be collected in sterile tube or cup containers with no preservative.
  • How was the COVID-19 Saliva Dx Test Kit validated?
    The test kit was validated for its sensitivity, specificity, endogenous interference and cross-reactivity, and clinical performance. Further details on the validation studies are described in the Instructions For Use.
  • Is the COVID-19 Saliva Dx Test Kit EUA authorized?

    This test kit has been validated by Chai pursuant to the FDA Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency, and an application for EUA authorization has been filed with the FDA. FDA’s independent review of this validation is pending.

    FDA is allowing distribution of the COVID-19 Saliva Dx Test Kit for diagnostic testing under the policy outlined in Section IV.C of the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. The FDA has listed the Chai COVID-19 Saliva Dx Test Kit on their website as a distributed kit under the FAQ question “What commercial manufacturers are distributing diagnostic test kits under the policy outlined in Section IV.C of the Policy for Coronavirus Disease-2019 Tests?.

  • Where can the COVID-19 Saliva Dx Test Kit be used?

    Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests.

    For surveillance testing outside of CLIA certified environments, please see our COVID-19 Surveillance solution.

  • Why is the dual channel Open qPCR required?
    A dual channel Open qPCR is required because the COVID-19 Surveillance Test Kit detects two targets, SARS-CoV-2 and the endogenous control. The SARS-CoV-2 target is detected in the FAM channel, and the endogenous control is detected in the HEX channel.
  • Do you ship internationally?
    Yes. We have distributors in most major regions. If we do not have a specific distributor in your country, we will ship and service the kits and instruments directly. Contact us at sales@chaibio.com to help you find the best way to purchase kits and instruments.

Resources



This test has not been FDA cleared or approved.

This test kit has been validated, but FDA’s independent review of this validation is pending.