Accula SARS-CoV 2 Test 25 Kit - CLIA Waived

Description of the Accula™ SARS-CoV-2 Test

Disclaimer: Please know that for all our CLIA WAIVED products, you need to fill out our CLIA Number section in order for us to process your order. If this section is empty and you proceed to check out, your order will be canceled.

The Accula Covid 19 SARS-CoV-2 Test developed by Mesa BioTech is a rapid diagnostic platform that is accurate like RT-PCR but simpler, more convenient, and more familiar to traditional rapid immunoassays. It has received an Emergency Use Authorization from the US Food and Drug Administration for the detection of SARS-CoV-2 in Clinical Laboratory Improvement Amendments (CLIA)–waived environments. The Accula SARS-CoV-2 Test provides reliable, qualitative results.

MesaBioTech Accula SARS-CoV-2 Test Kit is a nucleic acid amplification test (NAAT) that can detect SARS-CoV-2 viral RNA in about 30 minutes. An aliquot of the SARS-CoV-2 buffer is then added to the Accula SARS-CoV-2 buffer to solubilize the sample.

There are four steps in the process:

1. Lysis of the virus

2. Reverse transcription (RT) of viral RNA to cDNA

3. Nucleic acid amplification by PCR

4. Detection

Contents

This collection kit contains everything you need to collect 25 samples for testing for the SARS-CoV-2 virus. There are sterile swabs for collecting nasal samples, a single-use vial of buffer solution, and a single-use transfer pipette for transferring the sample from the buffer vial into the test cassette. The kit also includes 25 Accula SARS-CoV-2 test cassettes, which are single-use, foil-pouched, and contain lyophilized reagents for targeted amplification and detection of viral nucleic acid. Finally, the kit includes one high positive, one low positive, and one negative control swab, which are dried onto swabs and contain synthetic oligo DNA above the limit of detection of the test.

Specifications

Certifications/Compliance

FDA Emergency Use Authorized (EUA)

CLIA Complexity

Waived

Detectable Analytes

SARS-CoV-2 RNA

For Use With (Application)

RT-PCR, Rapid PCR

Organism Group

Virus

Shelf Life

Up to 18 months

Test Time

-30 minutes

Quantity

25

Important Documents

FDA Instructions For Use

Brochure

WARNINGS AND PRECAUTIONS

• Wear protective clothing such as laboratory coats, disposable gloves, and eye protection when handling samples.

• Do not use any damagedkitcontents.

• Do not touch the heads of the Control swabs. Cross-contamination may occur due to the high sensitivity of the test.

• Not for patient use.

• Follow proper infection control guidelines for handling all specimens, control swabs, and related items. Properly dispose of all contaminated waste according to federal, state, and local requirements.

• Swabs stored info il pouch at15°C - 30°C (59°F - 86°F) are stable until the expiration date printed on the pouch.

Bulk orders?

Please call us at +1 877-597-3224 for bulk orders or click here to know about our commercial accounts and B2B Wholesales discounts.

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How Long Does It Take For My Item(s) To Ship?

Items are shipped the same-day or next business-day from our warehouse.

Same-Day shipments are processed if orders are placed before 1:00PM EST on Business Days. (M-F)

Please feel free to contact support@peachmedical.com if you have any questions.

What Shipping Methods Do You Offer?

At Peach Medical we use both Fedex and UPS (most orders ship via UPS but some may ship via USPS) as our logistic and Shipping partners. We currently offer the following services:

UPS Next Day Air

UPS 2nd Day Air

UPS Ground (3-5 Day Delivery)

When Will I Receive My Tracking Number

Our system updates clients every evening with tracking numbers for their orders. This will be sent via e-mail with an additional copy of your receipt.

Incorrect Address

Please verify your address when ordering, we are unable to fix an incorrect shipping address on an order once it is in transit. If your order is in transit with an incorrect address, please reach out to your carrier to reroute the package. Peach Medical Sourcing is not able to have packages rerouted or contact the carrier on your behalf.

Refunds will not be issued for packages that were shipped to an incorrect address but it may be possible for a replacement package to be sent, please contact the customer service team to see if you are eligible.

Return Policy and Cancellation Policy

All sales are final. If items are found defective, the customer has 7 Business Days to request a return label. We are not responsible for any delays caused by shipping companies, ie: UPS, Fedex, DHL, Freight.

If a customer chooses a 3rd party receiver who is not the purchaser, Peach Medical Sourcing is not responsible for any goods once it leaves our warehouse and when tracking is provided. I.e Gifts, International Shipping Services.

Note: If Peach Medical Sourcing has not shipped your item within 7 business days, cancellations will be honored.

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