SCANTIBODIESClinical Laboratory

You “Otter” Know about PTH

(Parathyroid Hormone Testingand Renal Patient Care)

An education service of ScantibodiesLaboratories, manufacturer of 3rd Generation PTH Assays.

1-84 PTH / 7-84 PTH ratio

PTH AccuPTH AccuPTH AccuratioTM

7BR008 vs 01

otter_brochuremorepages 2/22/08 3:49 PM Page 6

Notes:________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

You “Otter” Use The PTH AccuratioTM

PTH Tracking Chart: 2000_________________________________1900_________________________________1800_________________________________1700_________________________________1600_________________________________1500_________________________________1400_________________________________1300_________________________________1200_________________________________1100_________________________________1000_________________________________900__________________________________800__________________________________700__________________________________600__________________________________500__________________________________400__________________________________300__________________________________200__________________________________100__________________________________0____________________________________

Date_____

Date_____

Date_____

For More Information Please Call:1-866-249-1212or visit our website at:www.scltesting.com

SCANTIBODIESClinical Laboratory

Date_____

Date_____

Date_____

Your Goal PTH level is:_____

otter_brochuremorepages 2/22/08 3:49 PM Page 5

- Performing monthly evaluations on each aspect of testing:

• the requisition • the order • the test• the reagent • the equipment

• quality control • the reporting process

All these steps are taken to be certain thatyour clinicians and physicians are given thebest diagnostic information possible toguide your care.

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Dialysis Master GOLD STANDARD2005 A

**ready**

IonameterGOLD

Parathyroid Glands

ParathyroidGlands

Thyroid Gland

What is PTH?

Parathyroid hormone or PTH is animportant hormone in the human bodywhich affects many bones and tissues.PTH lets the body know when to add ortake away minerals like calcium, mag-nesium and phosphorus from the bones.Since our bones are constantly beingrebuilt with new bone—referred to as“bone turnover”—this hormone plays avital role in bone health. When the kid-neys are not functioning normally orthe PTH hormone is out of balance,bones can “turnover” either too fast ortoo slowly. For the dialysis patient’sphysician, it is vital to know the level ofPTH to properly guide the patient’stherapy and care and provide for opti-mum bone health. This is accomplishedwhen the physician orders a blood testwhich is called a “PTH Assay” to meas-ure the level of PTH in the patient’s sys-tem.

Where does PTH come from?

PTH is a molecule of 84 amino acidswhich comes from the four tiny

18

Years

Better DiagnosticsMeans Better Care

Years

SCANTIBODIES Clinical Laboratory

otter_brochuremorepages 2/22/08 3:49 PM Page 4

parathyroid glands embedded in thethyroid gland in the front of the neck.Too much PTH in the body (which canoccur when the kidneys fail) results inhyperparathyroidism, or high PTH. Itcan cause a patient to feel bone pain,anemia and weakness. High PTH canalso result in blocked and cloggedarteries, nerve problems and a weak-ened immune system. Weak bonescannot produce healthy new red bloodcells. High bone turnover may bemanaged with calcium and vitamin D.However, too much calcium andvitamin D can cause health problemsof another kind.

For over 50 years it was assumed thatthere was only one parathyroid hor-mone in the human body. In 1998,Scantibodies Laboratory discoveredthat a second hormone (a large frag-ment called 7-84 PTH) was also secret-ed from the parathyroid gland andthat this hormone caused an oppositeeffect on the body to that of the full84 amino acid PTH molecule. High cal-cium and vitamin D levels can causethe parathyroid gland to produce andrelease an excessive amount of this7-84 PTH hormone resulting in acondition called Adynamic BoneDisease. Since it is important to knowthe correct value when measuring PTH,Scantibodies developed a way toaccurately measure the amount ofboth the 1-84 PTH and the 7-84 PTHhormones. Knowing the amount of

Scantibodies PTH assay.

You do not need to sign a billing con-sent form with SCL, as we are consid-ered an indirect treatment provider.This means we provide our testingbased on the order of the physician ordialysis clinic, and report resultsdirectly to the healthcare provider—not the patient.

In cases where an insurance companyneeds to be billed, SCL does offer thisservice on the patient’s behalf. Co-pays or deductibles are the responsi-bility of the patient.

The Advantages of PTH Testing withSCL versus other Labs:

Scantibodies Clinical Laboratory (SCL)is dedicated to determining the truemeasurement value in each patientblood sample and supplying betterdiagnostic information to physiciansfor better patient care. SCL “goes theextra mile” to provide quality andconsistency in results and reportingby:

- Testing all patient samples in duplicate

- Calibrating the equipment with each batch of samples (less than 200 samples per batch)

- Evaluating normal distribution statistics to ensure accuracy

72

otter_brochuremorepages 2/22/08 3:49 PM Page 3

dialysis and your doctor can better pre-scribe the correct supplements or therapyas part of your treatment plan.

What about Billing and Insurance forthese New Tests?

Consistent with their policy of reimburs-ing for medically necessary tests,Medicare does reimburse for both teststhat are needed to calculate the PTHAccuratio™ value. Your doctor will decidewhen the tests should be ordered basedon your medical diagnosis and necessity.

Some individual insurance carriers includelab services that include PTH testing aspart of their combined rate. If you arenot covered by Medicare or Medicaid,and have private health insurance, youshould ask your dialysis clinic to verifywith Scantibodies Clinical Lab that yourhealth insurance reimburses for the

both hormones allows your physicianto have a better understanding of thehealth of your bones.

Adynamic Bone Disease

Recent research has shown that greaterthan one out of every two renalpatients develop Adynamic BoneDisease – a condition which can becaused by the action of the 7-84 PTHfragment as it works against the 1-84PTH in the body. This results in loweringthe rate of bone turnover. This condi-tion makes the bones unable to use or

36

Insurance

7-84 PTH: A large fragment ofthe PTH molecule discovered in 1998, which has an opposite effect on the body to that of 1-84 PTH. SCL developed a way to accurately measure both 1-84 and 7-84 PTH hormones.

1-84 PTH: A parathyroidhormone molecule of 84 amino acids, discovered over 50 yearsago. Most tests are done assuming that they measure only this hormone—BUT they are also measuring…

7-84 PTH Molecule1-84 PTH Molecule

otter_brochuremorepages 2/22/08 3:49 PM Page 2

“buffer” calcium and phosphate, whichleads to a build-up of the minerals inthe arteries and soft tissues of the body.This build-up of minerals is called “calci-fication” and has been proven to be adangerous and sometimes fatal condi-tion. The majority of adynamic bone dis-ease patients are not identified withstandard PTH testing methods—onetest—usually an intact PTH test. In thepast, a painful and costly biopsy hasbeen the only way to get a true bonestatus. So Scantibodies Labs developeda new and better way of testing PTHand called it the “PTH Accuratio™”.

How Does the PTH Accuratio™Work?

By using a “whole PTH test” whichtests the entire 1-84 molecule ofPTH, and then a new “totalintact PTH test” which teststhe value of the 7-84 moleculeof PTH, a ratio of these twovalues can be calculated. From thepatient’s blood sample, the two valuesare measured and used to calculatethe Accuratio™. This is done by divid-ing the amount of 1-84 PTH by theamount of 7-84 PTH. By using this ratiovalue, the bone status of a patient canbe predicted with 94% accuracy - asproven by huge bone biopsy studies ofmore than 2,000 patients. By using thisbone status information, the physiciancan better select the correct therapy.

How Does this New Accuratio™ TestPanel Benefit the Dialysis Patient?

Rather than the physician arbitrarilyprescribing routine vitamin D or calciumtherapy based on a single, incompleteassay, the Accuratio™ value allows thephysician to know the status of thepatient’s bones and more precisely whatis needed to achieve a healthy PTHlevel.

Why is my PTH Level Higher with thisNew Testing?

In the past, your doctor may have givenyou a target level for the PTH value. Butnow, using the Accuratio™, he or shewill have a better understanding ofwhat the correct value should be.Also, it has been proven in bonebiopsy studies that the PTH target

values for African American andCaucasian patients are verydifferent.

What Should be My New Target PTHgoal?

Your doctor will be able to advise youof the correct target value for yourPTH level, based on the results of the

PTH Accuratio™ and the condition ofyour bones. Your body is very sensitiveto these conditions while you are on

54

CA

CA

CA CA

CA

X X

X

CACA

CA CA

CA

CA

CA

CA

As shown by this diagram, Adynamic Bone Disease is a condition whichcauses calcium to build up in the body. This causes a variety of needless

ailments that can be treated properly by using the Accuratio.

otter_brochuremorepages 2/22/08 3:49 PM Page 1

dialysis and your doctor can better pre-scribe the correct supplements or therapyas part of your treatment plan.

What about Billing and Insurance forthese New Tests?

Consistent with their policy of reimburs-ing for medically necessary tests,Medicare does reimburse for both teststhat are needed to calculate the PTHAccuratio™ value. Your doctor will decidewhen the tests should be ordered basedon your medical diagnosis and necessity.

Some individual insurance carriers includelab services that include PTH testing aspart of their combined rate. If you arenot covered by Medicare or Medicaid,and have private health insurance, youshould ask your dialysis clinic to verifywith Scantibodies Clinical Lab that yourhealth insurance reimburses for the

both hormones allows your physicianto have a better understanding of thehealth of your bones.

Adynamic Bone Disease

Recent research has shown that greaterthan one out of every two renalpatients develop Adynamic BoneDisease – a condition which can becaused by the action of the 7-84 PTHfragment as it works against the 1-84PTH in the body. This results in loweringthe rate of bone turnover. This condi-tion makes the bones unable to use or

36

Insurance

7-84 PTH: A large fragment ofthe PTH molecule discovered in 1998, which has an opposite effect on the body to that of 1-84 PTH. SCL developed a way to accurately measure both 1-84 and 7-84 PTH hormones.

1-84 PTH: A parathyroidhormone molecule of 84 amino acids, discovered over 50 yearsago. Most tests are done assuming that they measure only this hormone—BUT they are also measuring…

7-84 PTH Molecule1-84 PTH Molecule

otter_brochuremorepages 2/22/08 3:49 PM Page 2

parathyroid glands embedded in thethyroid gland in the front of the neck.Too much PTH in the body (which canoccur when the kidneys fail) results inhyperparathyroidism, or high PTH. Itcan cause a patient to feel bone pain,anemia and weakness. High PTH canalso result in blocked and cloggedarteries, nerve problems and a weak-ened immune system. Weak bonescannot produce healthy new red bloodcells. High bone turnover may bemanaged with calcium and vitamin D.However, too much calcium andvitamin D can cause health problemsof another kind.

For over 50 years it was assumed thatthere was only one parathyroid hor-mone in the human body. In 1998,Scantibodies Laboratory discoveredthat a second hormone (a large frag-ment called 7-84 PTH) was also secret-ed from the parathyroid gland andthat this hormone caused an oppositeeffect on the body to that of the full84 amino acid PTH molecule. High cal-cium and vitamin D levels can causethe parathyroid gland to produce andrelease an excessive amount of this7-84 PTH hormone resulting in acondition called Adynamic BoneDisease. Since it is important to knowthe correct value when measuring PTH,Scantibodies developed a way toaccurately measure the amount ofboth the 1-84 PTH and the 7-84 PTHhormones. Knowing the amount of

Scantibodies PTH assay.

You do not need to sign a billing con-sent form with SCL, as we are consid-ered an indirect treatment provider.This means we provide our testingbased on the order of the physician ordialysis clinic, and report resultsdirectly to the healthcare provider—not the patient.

In cases where an insurance companyneeds to be billed, SCL does offer thisservice on the patient’s behalf. Co-pays or deductibles are the responsi-bility of the patient.

The Advantages of PTH Testing withSCL versus other Labs:

Scantibodies Clinical Laboratory (SCL)is dedicated to determining the truemeasurement value in each patientblood sample and supplying betterdiagnostic information to physiciansfor better patient care. SCL “goes theextra mile” to provide quality andconsistency in results and reportingby:

- Testing all patient samples in duplicate

- Calibrating the equipment with each batch of samples (less than 200 samples per batch)

- Evaluating normal distribution statistics to ensure accuracy

72

otter_brochuremorepages 2/22/08 3:49 PM Page 3

- Performing monthly evaluations on each aspect of testing:

• the requisition • the order • the test• the reagent • the equipment

• quality control • the reporting process

All these steps are taken to be certain thatyour clinicians and physicians are given thebest diagnostic information possible toguide your care.

dfafds

first onecontrolsmeteringnumberfirst onesystemfirst onefirst oneresult

dfafds

dfafdsdfa

dfafds

dfafds

dfafds

dfafds

dfafds

00

00

00

00

00

00

Dialysis Master GOLD STANDARD2005 A

**ready**

IonameterGOLD

Parathyroid Glands

ParathyroidGlands

Thyroid Gland

What is PTH?

Parathyroid hormone or PTH is animportant hormone in the human bodywhich affects many bones and tissues.PTH lets the body know when to add ortake away minerals like calcium, mag-nesium and phosphorus from the bones.Since our bones are constantly beingrebuilt with new bone—referred to as“bone turnover”—this hormone plays avital role in bone health. When the kid-neys are not functioning normally orthe PTH hormone is out of balance,bones can “turnover” either too fast ortoo slowly. For the dialysis patient’sphysician, it is vital to know the level ofPTH to properly guide the patient’stherapy and care and provide for opti-mum bone health. This is accomplishedwhen the physician orders a blood testwhich is called a “PTH Assay” to meas-ure the level of PTH in the patient’s sys-tem.

Where does PTH come from?

PTH is a molecule of 84 amino acidswhich comes from the four tiny

18

Years

Better DiagnosticsMeans Better Care

Years

SCANTIBODIES Clinical Laboratory

otter_brochuremorepages 2/22/08 3:49 PM Page 4

Notes:________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________

You “Otter” Use The PTH AccuratioTM

PTH Tracking Chart: 2000_________________________________1900_________________________________1800_________________________________1700_________________________________1600_________________________________1500_________________________________1400_________________________________1300_________________________________1200_________________________________1100_________________________________1000_________________________________900__________________________________800__________________________________700__________________________________600__________________________________500__________________________________400__________________________________300__________________________________200__________________________________100__________________________________0____________________________________

Date_____

Date_____

Date_____

For More Information Please Call:1-866-249-1212or visit our website at:www.scltesting.com

SCANTIBODIESClinical Laboratory

Date_____

Date_____

Date_____

Your Goal PTH level is:_____

otter_brochuremorepages 2/22/08 3:49 PM Page 5

SCANTIBODIESClinical Laboratory

You “Otter” Know about PTH

(Parathyroid Hormone Testingand Renal Patient Care)

An education service of ScantibodiesLaboratories, manufacturer of 3rd Generation PTH Assays.

1-84 PTH / 7-84 PTH ratio

PTH AccuPTH AccuPTH AccuratioTM

7BR008 vs 01

otter_brochuremorepages 2/22/08 3:49 PM Page 6