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IBSSure

IBSSure

$237.00 - Free Shipping

A simple and reliable tool for detecting IBS-D associated with Small Intestinal Bacterial Overgrowth (SIBO)

At-home test: dried blood spot collection

Description

IBSSure: At-home test, dried blood spot collection

IBS is a commonly occurring collection of symptoms diagnosed in the world of gastroenterology. It is the most common GI disorder with worldwide prevalence rates ranging from 10-15%. There are between 2.4 and 3.5 million physician visits annually for IBS in the US. Recent research has shown that up to 84% of those with an IBS diagnosis test positive for a Small Intestinal Bacterial Overgrowth breath test.

Breath tests for Small Intestinal Bacterial Overgrowth can be very time consuming for patients, as well as inaccurate, due to many factors.

IBSSureTM is a simple blood test that detects two antibodies which are indicative of bacterial-pathogen-induced motility dysfunction, which can lead to increased incidence of SIBO.
CdtB toxins (cytolethal distending toxin B) are released by gastroenteritis-causing bacteria, against which antibodies are produced by the immune system. These antibodies interact with a protein, vinculin, present in the intestinal cell-lining matrix. This interaction compromises and impairs digestive motility. This pathological breakdown of the gastrointestinal motility complex is foundational to chronic SIBO development and recurrence and has been well-studied and documented.

IBSSure Sample Report

Markers Measured

IBSSure Blood Test markers measured:

  • Anti-CdtB IgG and IgA
  • Anti-vinculin IgG and IgA

Symptoms

SIBO Symptoms

WHAT IS SIBO?

  • Small intestinal bacterial overgrowth (SIBO) is defined as the presence of excessive bacteria in the small intestine
  • SIBO is frequently implicated as the cause of chronic diarrhea and malabsorption in addition to intestinal hyper-permeability
  • Patients with SIBO may also suffer from unintentional weight loss, nutritional deficiencies, and osteoporosis
  • A common misconception is that SIBO affects only a limited number of patients, such as those with an anatomic abnormality of the upper gastrointestinal (GI) tract or those with a motility disorder
  • SIBO may be more prevalent than previously thought. This apparent increase in prevalence may have occurred, in part, because readily available diagnostic tests have improved our ability to diagnose SIBO

Symptoms associated with SIBO

  • Abdominal pain/discomfort
  • Bloating
  • Abdominal distension
  • Diarrhea
  • Excessive gas
  • Fatigue, especially after meals
  • Brain fog
  • Vitamin and mineral deficiencies
  • Worsened symptoms when consuming carbohydrates and fibrous vegetables
  • Unexplained weight loss

About Test

About IBSSure Test

This is a dry blood spot (DBS) collection that is done at home.

You will receive a kit with full instructions. When you receive your kit please open it up and lay out the instructions and contents of your kit and get familiar with them.

You will be sent a lancet (to prick your finger with), as well as a blood specimen collection card. Simply follow the instructions to 'fill' your card with blood spots.

View detailed collection instructions with images here (PDF)

STEP 1

Before you begin, make sure you will have at least 15 minutes of uninterrupted time. First, find a clean, open space to work on. Open the DBS collection kit and lay out all of your materials on the placemat (the last page) provided.

Please wear appropriate PPE ( personal protective equipment) while collecting the specimen from the patient.

* You will be given as many Blood specimen collection cards as required by your lab order.
* All DBS cards need to be filled for testing. Failure to complete all cards will result in the test not being performed.

STEP 2

Write the name and DOB on the card. Write the date and time on the blood specimen collection card.

STEP 3

Open the alcohol wipe.

STEP 4

Wash your hands and dry them with a clean towel. Make sure the water is warm, not hot.

This is very important as it will stimulate blood flow to the hands!

STEP 5

Choose a finger to poke on your non-dominant hand. If you are left-handed, choose your right hand. If you are right-handed, choose your left hand.

STEP 6

Choose an area on the side of your finger to poke (you'll see a visual in the instructions).

STEP 7

Pick up your lancet and twist the cap off.

STEP 8

Rub your finger from base to tip.

STEP 9

Put the lancet down and wipe the tip of your finger with the alcohol wipe.

Make sure to only wipe the finger in one single swoop!

STEP 10

With your palm facing up, press the lancet to your finger until you hear a click and feel a slight pinch.

STEP 11

Wipe the first drop of blood away with a gauze pad.

STEP 12

Milk your finger from base to tip to produce more blood.

STEP 14

Let the blood drop fall from your fingertip into the collection circle.

DO NOT touch your finger to the card. Fill the circle as full as possible, but do not add a second drop of blood to a circle. If necessary, use a second lancet!

STEP 15

After filling in all of the collection card circles, use your gauze pad to wipe the blood, apply pressure and apply a bandage.

STEP 16

Please discard the bio waste, including used lancet, alcohol pads, and gauze sponge, in an appropriate Biohazard waste container.

STEP 17

Let your collection card sit for at least 2 hours to dry before sending it back to us.

Keep the collection card in a cool, dry place away from sunlight.

Do not add additional blood drops after blood spots have dried.

Blood spots will darken as they dry.

STEP 18

After the blood spots have dried for at least 2 hours, fold the collection card, place it in the biohazard bag along with the humidity indicator and silica gel packs, and seal it tight.

STEP 19

Place the biohazard bag into the bubble mailer. Wash hands to prevent contamination. Please schedule Fedex Pick up for the specimen to be picked up from your office.

The Vibrant Experience

Vibrant America is a leading science and technology company delivering life-transforming laboratory services using an integrated microarray platform that enables multiplex testing at an affordable cost.

Vibrant’s relationship with its patients and providers is special. We go out of our way to provide the value and resources our providers need to accurately interpret test results and give patients the most accurate health information.

The Most Accurate In the Industry

All tests run on Vibrant’s proprietary 3Dense microchip technology platform boast an unrivaled specificity and sensitivity – which translates to the highest standard of accuracy of results in the lab industry.

Our Lab Technology

Vibrant America is at the forefront of modern medicine. Our technology was developed out of passion for better medicine, and we believe that automation is the key to high-quality and accurate test results. Multiplexing tests on a single sample enable a fast turnaround time.

Our Mission

Dedicated to bring clinically relevant test at a rapid pace to enable affordable high-quality diagnostics to every individual.

  • High-quality lab service
  • Fully automated systems
  • Low cost
  • Fast Turn Around Time

Quality and Security

All of our laboratory testings is done in a CLIA and CAP-certified laboratory in California.

Vibrant America's Compliance Overview

 

FAQ

FAQ

How do I know if my blood spots are big enough?

You’ll know if you have enough blood if the blood spot fills most of the collection circle. Try your best to fill all five circles.

My blood drops fell outside of the collection circles. Is this okay?

Yes, it is fine if the blood drops don’t fit neatly into the circles, but try to get them as close as possible.

I am nervous to poke my finger. What should I do?

Most people have said that the anticipation is worse than the poke itself. It should only feel like a slight “pinch.”

I poked my finger but am not getting enough blood out. What should I do?

First, try standing up and milking your finger below your waist. You can also try shaking your hand below your waist. If that doesn’t help, you can run your fingers under warm water while milking them to stimulate blood flow.

If blood still isn’t flowing, it has probably clotted. Wipe your finger with the alcohol wipe and apply a bandage. Try again later. It may help to take a break and drink a glass of water and move around. This will help stimulate blood flow to your fingers. Then, try again. This time poke another finger or a different spot on the same finger, and then try the process again.

If this test is negative but I still have the symptoms, is it possible that I might still have SIBO?

IBSSureTM measures two blood-based antibodies that can be used in the diagnostic workup of IBS, and to rule out IBD. These antibodies can also identify past exposure to bacterial toxin (food poisoning), and autoimmunity of the intestinal motility system (pacemaker cells in the GI tract). Finally, anti-CdtB antibody has been correlated with positive SIBO diagnosis. It is still possible to have the signs and symptoms of SIBO without having a positive result on this test.

If this test is capturing an infectious gastroenteritis event, how many years back would the event be accounted for?

A systematic review and meta-analysis found that more than 10% of individuals with infectious enteritis later develop IBS. The overall risk of developing IBS is 4.2 times higher in individuals with a history of infectious enteritis versus individuals without a history of infectious enteritis. The prevalence of IBS at 12 months after infectious enteritis was 10.1% and at more than 12 months after infectious enteritis was 14.5%. Studies have examined post-infectious IBS onset within 12 months, within 13-59 months, and greater than 60 months (5 years) after the infectious event. Prevalence of post-infectious IBS depends upon the pathogen(s) involved, geographic location, clinically suspected or laboratory-proven enteritis, time of medical assessment following the infectious enteritis, and the criteria used to define IBS. Some studies report a decline in prevalence of IBS over time since the infectious event, whereas others report an increase in prevalence of IBS over time since the infectious event. It is unknown how long CdtB antibodies and vinculin antibodies will persist after an infectious enteritis.

Does positive anti-vinculin indicate an autoimmune condition?

Yes, because the body is producing antibodies to the vinculin protein located in the migrating motor complex (MMC), therefore, antibodies to its own tissues.

What does IBS-M mean?

IBS-M means Irritable Bowel Syndrome – Mixed, which means the patient experiences a combination of constipation and diarrhea.

I was told that this is not a SIBO test. What is IBSSure testing?

Vibrant’s IBSSureTM is a simple, gut-motility test that can be used to identify irritable bowel syndrome (IBS), and to rule out inflammatory bowel disease (IBD). We identify two markers: CdtB (Cytolethal Distending Toxin B) and anti-vinculin, which confirms dysmotility at the junction of the large and small intestine; this could present itself symptomatically as diarrhea or constipation. The importance of understanding the migrating motor complex (MMC) can help alleviate your patient’s symptoms. Should both biomarkers be elevated, there is an 89% correlation to SIBO. Simple intervention of a prokinetic supplementation and lifestyle changes that will stimulate the MMC could provide your patient with symptomatic alleviation.

How It Works

1

Order your test

You'll get an email confirmation from us.

2

Within 48 hours of payment

The lab will confirm your order and provide tracking.

3

2 days after kits ship

We will send you test instructions.

4

When results are in

You'll be notified via email, with instructions to access via secured portal.

5

Interpretation

Learn how to read your lab report.

*Please read the following prior to placing your lab test order*

  • All sales are final and no refunds will be afforded and you waive any rights to charge-back your purchase with your credit card processor.
  • Vibrant does not participate in, take assignment, or accept any private insurance. We do not provide super bills and cannot assist with claim resolution for laboratory tests or consultations.
  • Orders for this test are accepted from the United States only.
  • Vibrant is unable to ship test kits to the state of New York as per state laws.
  • Vibrant is unable to ship lab kits to P.O. boxes. Please use a residential or business address.
  • After you order a test kit, getting the lab draw and/or completing the test is your responsibility.
  • Once Vibrant has received your test results, the results will be uploaded to your HIPAA compliant client portal and you will receive an email instructing you how to access them.
  • All Vibrant tests are done at Vibrant America Clinical Labs.
  • You will receive a link with follow up instructions after your order is completed.

Before Placing Your Order Please Read
The Complete Terms and Conditions for Vibrant Test Orders

*These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease.

*Regulatory Statement*
Vibrant testing does not demonstrate absolute positive and negative predictive values for any disease state or condition. Its clinical utility has not been fully established. Vibrant validates the accuracy and precision of the testing but not of its clinical or diagnostic value. So these tests are for wellness and informational purpose only. Vibrant is actively doing clinical research on these samples, de-identified from patients under an IRB and will make research publications towards the same as and when the clinical utility is well established. These tests have been laboratory developed and their performance characteristics determined by Vibrant America LLC, a CLIA-certified laboratory performing the test CLIA#:05D2078809. The test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). Although FDA does not currently clear or approve laboratory-developed tests in the U.S., certification of the laboratory is required under CLIA to ensure the quality and validity of the tests. The general wellness test intended uses relate to sustaining or offering general improvement to functions associated with a general state of health while making reference to diseases or conditions. Content provided for informational purposes only and should not be construed as medical advice. Content provided to help you make a healthy lifestyle, dietary, and treatment choices in consultation with your healthcare provider. It is intended to be used as a tool to encourage a general state of health and well-being. Please consult with your healthcare practitioner for diagnosis and treatment considerations. The Vibrant Wellness platform provides tools for you to track and analyze your general wellness profile.