COVID-19 Saliva Dx Test Kit

Overview

• Detect COVID with minimally-invasive, easy-to-collect, and safe saliva samples
• Low-cost, two-step direct viral RNA extraction eliminates the need for purification
• 60-minute PCR run time and minimal hands-on time means higher lab processing throughput

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 swabs. The built-in UNG carry-over prevention system minimizes false positives and reduces the need for costly repeat testing.

Saliva: A Non-invasive, Reliable Testing Specimen

COVID testing with saliva samples is non-invasive, easy, and safe. Patients can reliably self-collect samples, minimizing viral exposure to health personnel. The simple collection method reduces the risk of errors made in more complicated sampling procedures, which lead to false negatives or costly repeat testing.

In contrast, deep nasopharyngeal (NP) swabs are invasive and uncomfortable for patients. They can induce sneezing or coughing in patients, which is hazardous to everyone in the vicinity, especially the healthcare workers administering the test. Specialized training is required to perform the collection protocol.

Researchers have found saliva as sensitive, if not more, than NP swabs for detection and diagnosis of SARS-CoV-2^{1Wyllie AL, Fournier J, Casanovas-Massana A, Campbell M, Tokuyama M, Vijayakumar P et al. Mak GC, Cheng PK, Lau SS, Wong KK, Lau CS, Lam ET et al. Saliva is more sensitive for SARS-CoV-2 detection in COVID-19 patients than nasopharyngeal swabs. New England Journal of Medicine. 2020;383: 1283–1286.1Yee R, Truong T, Pannaraj PS, Eubanks N, Gai E, Jumarang J et al. Saliva is a Promising Alternative Specimen for the Detection of SARS-CoV-2 in Children and Adults. Journal of Clinical Microbiology. 2020;1–19.}. Saliva and NP swabs in VTM also demonstrated equivalence in our internal validation study.

Low-cost, High-throughput Viral RNA Extraction

The 10X Enzymatic DNA/RNA Extraction Buffer enables fast and efficient viral detection, and maintains sensitivity through concentrating the lysis buffer to remove sample dilution effects. Enzymes digest RNase, protecting RNA from degradation for maximum yield, and PCR inhibition is minimized for successful downstream molecular processing.

The buffer removes the need for expensive and manually-intensive RNA purification steps and associated consumables, allowing more samples to be processed in a day and reducing the cost per extraction to $1/sample. Adding the extraction buffer to the sample inactivates the virus immediately, eliminating the risk of viral exposure to lab professionals.

How It Works

• 

  RNA Extraction

  Two simple steps that take less than 30 minutes.

  Step 1: Add 20 µL of extraction buffer to the sample, mix, and incubate the tube at room temperature for 15 minutes.

  Step 2: Move the tube into a 95 °C dry bath and incubate for 10 minutes. Centrifuge for 20 seconds. Sample lysate contains the extracted RNA.

• 

  Set Up RT-qPCR Reaction and Run

  Step 1: Prepare and aliquot 17.5 µL of the Common Mix into PCR tubes or plate wells.

  Step 2: Add 2.5 µL of the required template (sample lysate, negative control, and positive control) into their respective tubes or plate wells. Seal plate or tubes and centrifuge for 30 seconds.

  Step 3: Load and run the qPCR instrument.

• 

  Get Results

  Get clear results in 60 minutes.

• View the Instructions for Use for the detailed protocol.

Accurate, Sensitive Results

Carry-over contamination, where amplicons leftover from previous runs contaminate subsequent ones, is a common cause of false positives in PCR testing. Our UNG carry-over prevention system uses Uracil-DNA Glycosylase (UNG) to increase accuracy by degrading those amplicons within the PCR mixture.

The assay uses PCR technology, the gold standard and most sensitive method of COVID detection. It reduces inconclusive results and the need for repeat testing. A viral infection can be detected in as little as 5.8 viral copies/µL.Detect an infection with as little as 5.8 viral particles/µL

Quick Start Bundle

Chai’s COVID-19 Saliva Dx Quick Start Bundle
includes everything you need to start SARS-CoV-2 diagnostic testing today

Open qPCR instrument, dual channel

Two-Year Service Plan

Protect your investment with comprehensive service plans:

• Covers all repairs for duration of plan
• Covers shipping for repairs within U.S.
• Covers "hot-swaps": if your unit requires service, we will send you a replacement device

View full coverage details

COVID-19 Saliva Dx Test Kit for 100 tests

Enzymatic DNA/RNA Extraction Buffer 10X

View all included equipment + supplies

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Equipment

Open qPCR instrument, dual channel

Two-year service plan

Protect your investment with comprehensive service plans:

• Covers all repairs for duration of plan
• Covers shipping for repairs within U.S.
• Covers "hot-swaps": if your unit requires service, we will send you a replacement device

View full coverage details

Mini centrifuge

Mini dry bath

Vortex mixer

10 μL, 100 μL and 1000 μL pipettes

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

Upgrade to Five-Year Service Plan (+$1,640)

5 Year - $1,640

• 5 Year - $1,640
• 2 Year - $0

Add to Cart $15,640

Intended Use

The Chai COVID-19 Saliva Dx Test Kit is a RT-qPCR test intended for the qualitative detection of the SARS-CoV-2 virus in upper and lower respiratory specimens including nasopharyngeal swabs 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

Kit Components

FAQs

• Can this assay detect Omicron, Delta, and other variants of SARS-CoV-2?

  Yes, as of June 10, 2022, we’ve performed BLAST analysis of available whole genome sequences, and the assay’s ability to detect all current WHO variants of concern, including Delta and Omicron BA.1, BA.2, BA.3, BA.4, and BA.5 sublineages is unaffected.

  The SARS-CoV-2 virus is constantly mutating as it spreads globally. We monitor sequences published to scientific databases such as GISAID on a regular basis and will update this FAQ as appropriate.

• 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.