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To assist with control of blood glucose levels, the American Diabetes Association (ADA) has recommended glycated hemoglobin testing (HbA1c) twice a year for patients with stable glycemia, and quarterly for patients with poor glucose control. Interpretive ranges are based on ADA guidelines

An elevated concentration of Homocysteine is an independent risk factor for cardiovascular disease.

Measurement of serum 25-OH vitamin D concentrations provide a good index of circulating vitamin D activity in patients not suffering from renal disease. Lower than normal 25-OH vitamin D levels can result from a dietary deficiency, poor abosrption of the vitamin or impaired metabolism of the sterol in the liver. A 25-OH vitamin D deficiency can lead to bone diseases such as rickets and osteomalacia. Above normal levels can lead hypercalcemia. This assay employs liquid chromatography tandem mass spectrometry to independently measure and report the two common forms of 25-hydroxy vitamin D: 25OH D3 - the endogenous form of the vitamin and 25OH D2 - the analog form used to treat 25OH Vitamin D3 deficiency.

Cardio IQ® Lipoprotein Subfractionation, Ion Mobility

Clinical Significance

There is a correlation between increased risk of premature heart disease with decreasing size of LDL particles. Ion mobility offers the only direct measurement of lipoprotein particle size and concentration for each lipoprotein from HDL3 to large VLDL.

Includes

HDL Particle Number; LDL Particle Number; Non-HDL Particle Number; HDL, Small; HDL Large; LDL, Very Small-d; LDL, Very Small-c; LDL, Very Small-b; LDL, Very Small-a; LDL Small; LDL Medium; LDL, Large-b; LDL, Large-a; IDL, Small; IDL, Large; VLDL, Small; VLDL, Medium; VLDL, Large; LDL Pattern; LDL Peak Size

Patient Preparation

Fasting preferred

Methodology

Ion Mobility

 


 Specimens from children less than 4 years of age (i.e., less than 48 months) are not appropriate for this test. The test for children 4 years of age and younger is the Celiac Disease Comprehensive Panel, Infant (test code 15981).

Includes

Tissue Transglutaminase, IgA with Reflexes; Total IgA with Reflex

IMPORTANT - Note this is Reflex Test which if additional tests are run you will be charged for the specific tests that the lab peforms. Additional test will be run if the following criteria are met.


If the Tissue Transglutaminase IgA is positive,

1. Endomysial Antibody Screen (IgA) will be performed at an additional charge (CPT code(s): 86255).

If the Endomysial Antibody Screen (IgA) is positive, 

2. Endomysial Antibody Titer will be performed at an additional charge (CPT code(s): 86256).

If the Total IgA is less than the lower limit of the reference range, based on age

3. Tissue Transglutaminase IgG will be performed at an additional charge (CPT code(s): 83516).

Clinical Significance

Celiac disease is caused by an immune response to gluten in genetically sensitive individuals. The diagnosis is largely based on a biopsy of the small intestine, but serologic tests also help support a diagnosis and may assist identification of patients who may require biopsy.

Tissue transglutaminase antibodies (tTG, IgA) is a marker with 95% sensitivity and specificity. Total IgA is measured because 2-3% of celiac disease patients are IgA deficient. Because tTG, IgA, and anti-Gliadin IgA tend to decrease in patients on a gluten-free diet, these markers are also used to assess dietary compliance.

The endomysial antibody (EMA, IgA) assay has high specificity for celiac disease and is used to confirm positive anti-tTG results.


Cortisol is increased in Cushing's Disease and decreased in Addison's Disease (adrenal insufficiency). Patient needs to have the specimen collected between 7 a.m.-9 a.m.


Useful in the diagnosis of hypochromic, microcytic anemias. Decreased in iron deficiency anemia and increased in iron overload.


Folic acid deficiency is common in pregnant women, alcoholics, in patients whose diets do not include raw fruits and vegetables, and in people with structural damage to the small intestine. The most reliable and direct method of diagnosing folate deficiency is the determination of folate levels in both erythrocytes and serum. Low folic acid levels, however, can also be the result of a primary vitamin B12 deficiency that decreases the ability of cells to take up folic acid


  • T3 Reverse (RT3), LC/MS/MS
  • T3, Free
  • T4, Free
  • Thyroid Peroxidase and Thyroglobulin Antibodies
  • TSH

Assesses long term diabetic control in diabetes mellit

Hepatitis A & B Titer Test

  • Hepatitis A Antibody, Total
  • Hepatitis A IgM Antibody
  • Hepatitis B Surface Antigen with Reflex Confirmation
  • Hepatitis B Surface Antibody Immunity, Quantitative
  • Hepatitis B Core Antibody, Total

The Hepatitis A & B Titer Test is ordered when a person needs proof of immunity to Hepatitis A and B or just want to check their immune status.

The Hepatitis Titer Test includes immunity testing for both Hepatitis A and B.  Hepatitis is a viral disease which affects the liver.  Vaccinations for Hepatitis A and B can provide protective antibodies which immunize a person from catching the virus.  Additionally, a person who has been affected by Hepatitis A or B and recovers can develop natural immunity.  Titer testing looks for the antibodies which typically indicate that a person is immune to a particular virus or infection.

Hepatitis B Immunity

Not Immune and no active or prior infection; may be a good candidate for vaccine

  • Hepatitis B Surface Antigen (HBsAg) = Negative
  • Hepatitis B Surface Antibody (Anti-HBs) = Negative
  • Hepatitis B Core Antibody, Total (Anti-HBc IgG+IgM) = Negative

Immunity due to vaccination

  • Hepatitis B Surface Antigen (HBsAg) = Negative
  • Hepatitis B Surface Antibody (Anti-HBs) = Positive
  • Hepatitis B Core Antibody, Total (Anti-HBc IgG+IgM) = Negative

HEPATITIS B INFECTION

  • Hepatitis B Surface Antigen (HBsAg) = Positive  A positive result indicates an infection, usually with symptoms; contagious; could also be a flare of a chronic infection

Hepatitis A immunity

Immunity

  • Hepatitis A Antibody, Total = Positive
  • Hepatitis A IgM Antibody = Negative

No active infection but previous HAV exposure; has developed immunity to HAV or recently vaccinated for HAV

No Immunity

  • Hepatitis A Antibody, Total= Negative
  • Hepatitis A IgM Antibody = Negative

No current or previous HAV infection; vaccine may be advised if at risk

HEPATITIS A INFECTION

  • Hepatitis A IgM Antibody = Positive   A positive result indicates an acute or recent infection

 


Hepatitis A Antibody Test to diagnose the Hepatitis A Virus (HAV) in the blood. The hepatitis A test looks for antibodies to the HAV virus in the blood. These antibodies are proteins made by the body in response to the presence of the hepatitis A virus. Our type- specific hepatitis A antibody test is used to determine whether a person is or has been infected with the hepatitis A virus.

Hepatitis A Antibody, Total

This test is used to help diagnose a liver infection due to the hepatitis A virus. There are several causes of hepatitis and the accompanying symptoms, so this test may be used to determine if the symptoms are due to hepatitis A.

The total Hepatitis A antibody test detects both IgM and IgG antibodies and thus may be used to identify both current and past infections. This test will also be positive after receiving the vaccine, so sometimes it may be used to determine whether a person has developed immunity after vaccination.

A positive result Hepatitis A Antibody, Total that is not accompanied with Hepatitis A IgM test indicates  exposure to hepatitis A vairus but does not rule out acute infection. 

A Negative result Hepatitis A Antibody, Total that is not accompanied with Hepatitis A IgM test indicates no current or previous HAV infection; vaccine may be recommended if at risk.


Hepatitis A Titer Test Panel

  • Hepatitis A Antibody, Total
  • Hepatitis A IgM Antibody

The Hepatitis A Titer Test is ordered when a person needs proof of immunity to Hepatitis A or just want to check their immune status.

The Hepatitis A Titer Test includes immunity testing for Hepatitis A.  Hepatitis is a viral disease which affects the liver.  Vaccinations for Hepatitis A can provide protective antibodies which immunize a person from catching the virus.  Additionally, a person who has been affected by Hepatitis A and recovers can develop natural immunity.  Titer testing looks for the antibodies which typically indicate that a person is immune to a particular virus or infection.

Hepatitis A immunity

Immunity

  • Hepatitis A Antibody, Total = Positive
  • Hepatitis A IgM Antibody = Negative

No active infection but previous HAV exposure; has developed immunity to HAV or recently vaccinated for HAV

No Immunity

  • Hepatitis A Antibody, Total= Negative
  • Hepatitis A IgM Antibody = Negative

No current or previous HAV infection; vaccine may be advised if at risk

HEPATITIS A INFECTION

  • Hepatitis A IgM Antibody = Positive   A positive result indicates an acute or recent infection

The Hepatitis B test detects acute hepatitis B infections, and can also be used to help diagnose chronic hepatitis B infections. Detecting an early hepatitis B infection is important to avoid health complications. If the HBV test positive returns a positive result for hepatitis B, our labs will automatically run a confirmation test at no additional cost– This ensures that you receive the most sensitive and accurate results.

Hepatitis B Surface Antigen with Reflex Confirmation: Positive samples will be confirmed

Hepatitis B surface antigen (HBsAG) Detects protein that is present on the surface of the virus.  It is used to screen for, detect, and help diagnose acute and chronic hepatitis B virus (HBV) infections; earliest routine indicator of acute hepatitis B and frequently identifies infected people before symptoms appear; undetectable in the blood during the recovery period; it is the primary way of identifying those with chronic infections, including "hepatitis B virus (HBV) carrier" state.

Clinical Significance

Surface antigen usually appears in the serum after an incubation period of 1 to 6 months following exposure to Hepatitis B virus and peaks shortly after onset of symptoms. It typically disappears within 1 to 3 months. Persistence of Hepatitis B surface antigen for greater than 6 months is a prognostic indicator of chronic Hepatitis B infection.


Hepatitis B Titer Test

  • Hepatitis B Surface Antigen with Reflex Confirmation
  • Hepatitis B Surface Antibody Immunity, Quantitative
  • Hepatitis B Core Antibody, Total

The Hepatitis B Titer Test is ordered when a person needs proof of immunity to Hepatitis B or just want to check their immune status.

The Hepatitis Titer Test includes immunity testing for Hepatitis B.  Hepatitis is a viral disease which affects the liver.  Vaccinations for Hepatitis B can provide protective antibodies which immunize a person from catching the virus.  Additionally, a person who has been affected by Hepatitis B and recovers can develop natural immunity.  Titer testing looks for the antibodies which typically indicate that a person is immune to a particular virus or infection.

Hepatitis B Immunity

Not Immune and no active or prior infection; may be a good candidate for vaccine

  • Hepatitis B Surface Antigen (HBsAg) = Negative
  • Hepatitis B Surface Antibody (Anti-HBs) = Negative
  • Hepatitis B Core Antibody, Total (Anti-HBc IgG+IgM) = Negative

Immunity due to vaccination

  • Hepatitis B Surface Antigen (HBsAg) = Negative
  • Hepatitis B Surface Antibody (Anti-HBs) = Positive
  • Hepatitis B Core Antibody, Total (Anti-HBc IgG+IgM) = Negative

HEPATITIS B INFECTION

  • Hepatitis B Surface Antigen (HBsAg) = Positive  A positive result indicates an infection, usually with symptoms; contagious; could also be a flare of a chronic infection.

Hepatitis C Antibody, HCV RNA & Liver Panel

  • Hepatitis C Antibody
  • Hepatitis C Virus RNA, Quantitative, Real-Time PCR
  • Hepatic Function Panel

Hepatitis C antibody tests are used to screen individuals for the infection, including, people with no signs or symptoms but with risk factors, people who have symptoms associated with hepatitis or liver disease, or those who have been exposed to the virus.

Since the antibody test can remain positive for most people even if they have cleared the infection, this panel includes a hepatitis C RNA test, which detects the genetic material of the virus. A positive result on the RNA test means the virus is present, the infection has not resolved, and the person may require treatment. The liver panel is included to assess the health of the liver.

An HCV antibody test is typically reported as "positive" or "negative."

Results of Hepatitis C Virus RNA testing are reported as a number if virus is present. If no virus is present or if the amount of virus is too low to detect, the result is often reported as "negative" or "not detected."

Interpretation of the HCV screening and follow-up tests is shown below. In general, if the HCV antibody test is positive, then the individual tested is infected or has likely been infected at some time with hepatitis C. If the Hepatitis C Virus RNA test is positive, then the person has a current infection. If no Hepatitis C Virus RNA is detected, then the person either does not have an active infection or the virus is present in very low numbers.

HCV Antibody = Negative

No infection or too early after exposure for the test to be accurate; if suspicion remains high, retesting at a later time may be required.

_________________________

HCV Antibody = Positive or Indeterminate

HCV RNA = Negative

Past infection or no infection (false-positive screen); additional testing if indicated

_____________________

HCV Antibody = Positive or Weak or Indeterminate

HCV RNA = Positive

Current infection


Includes

Hepatitis A Antibody, Total; Hepatitis B Surface Antibody, Qualitative; Hepatitis B Surface Antigen with Reflex Confirmation; Hepatitis B Core Antibody, Total; Hepatitis C Antibody with Reflex to HCV, RNA, Quantitative, Real-Time PCR

Hepatitis B Surface Antigen with Reflex Confirmation: Positive samples will be confirmed based on the manufacturer's FDA approved recommendations at an additional charge (CPT code(s): 87341).


If Hepatitis C Antibody is reactive, Hepatitis C Viral RNA, Quantitative, Real-Time PCR will be performed at an additional charge (CPT code(s): 87522).


Herpes Simplex Virus 1 (IgG), Type-Specific Antibody (HerpeSelect®) 

Tests for HSV 1 IGG, TYPE SPECIFIC AB to diagnose HSV-1 infection when lesions are absent. A positive HSV-1 IgG antibody test indicates a previous infection.

Reference Range(s)

Index Interpretation

  • <0.90 Negative 
  • 0.90-1.09 Equivocal 
  • >1.09 Positive 

This assay utilizes recombinant type-specific antigens to differentiate HSV-1 from HSV-2 infections. A index positive result cannot distinguish between recent and past infection. If recent HSV infection is suspected but the results are negative or equivocal, the assay should be repeated in 4-6 weeks. The performance index characteristics of the assay have not been established for pediatric populations, immunocompromised patients, or neonatal screening.

Limitations

Individuals infected with HSV may not exhibit detectable IgG antibody in the early stages of infection.

Clinical Significance

Herpes Simplex Virus (HSV) is responsible for several clinically significant human viral diseases, with severity ranging from inapparent to fatal. Clinical manifestations include genital tract infections, neonatal herpes, meningoencephalitis, keratoconjunctivitis, and gingivostomatitis. There are two HSV serotypes that are closely related antigenically. HSV type 2 is more commonly associated with genital tract and neonatal infections, while HSV type 1 is more commonly associated with infections of non-genital sites. Specific typing is not usually required for diagnosis or treatment. The mean time to seroconversion using the type specific assay is 25 days. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, or for testing of immunocompromised patients.


Herpes Simplex Virus 1/2 (IgG), Type-Specific Antibodies (HerpeSelect®) 

  1. HSV 1 IGG, TYPE SPECIFIC AB
  2. HSV 2 IGG, TYPE SPECIFIC AB

Diagnose HSV infection when lesions are absent; determine HSV type

Reference Range(s)

Index Interpretation

  • <0.90 Negative
  • 0.90-1.09 Equivocal
  • >1.09 Positive

This assay utilizes recombinant type-specific antigens to differentiate HSV-1 from HSV-2 infections. A index positive result cannot distinguish between recent and past infection. If recent HSV infection is suspected but the results are negative or equivocal, the assay should be repeated in 4-6 weeks. The performance index characteristics of the assay have not been established for pediatric populations, immunocompromised patients, or neonatal screening.

Limitations

Individuals infected with HSV may not exhibit detectable IgG antibody in the early stages of infection.

Clinical Significance

Herpes Simplex Virus (HSV) is responsible for several clinically significant human viral diseases, with severity ranging from inapparent to fatal. Clinical manifestations include genital tract infections, neonatal herpes, meningoencephalitis, keratoconjunctivitis, and gingivostomatitis. There are two HSV serotypes that are closely related antigenically. HSV Type 2 is more commonly associated with genital tract and neonatal infections, while HSV Type 1 is more commonly associated with infections of non-genital sites. Specific typing is not usually required for diagnosis or treatment. The mean time to seroconversion using the type specific assay is 25 days. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, or for testing of immunocompromised patients.


Herpes Simplex Virus 2 (IgG), Type-Specific Antibody (HerpeSelect®) 

HSV 2 IGG, TYPE SPECIFIC AB - Diagnose HSV-2 infection when lesions are absent.

Reference Range(s)

Index Interpretation

  • <0.90 Negative
  • 0.90-1.09 Equivocal
  • >1.09 Positive

This assay utilizes recombinant type-specific antigens to differentiate HSV-1 from HSV-2 infections. A index positive result cannot distinguish between recent and past infection. If recent HSV infection is suspected but the results are negative or equivocal, the assay should be repeated in 4-6 weeks. The performance index characteristics of the assay have not been established for pediatric populations, immunocompromised patients, or neonatal screening.

Limitations

Individuals infected with HSV may not exhibit detectable IgG antibody in the early stages of infection.

Clinical Significance

Herpes Simplex Virus (HSV) is responsible for several clinically significant human viral diseases, with severity ranging from inapparent to fatal. Clinical manifestations include genital tract infections, neonatal herpes, meningoencephalitis, keratoconjunctivitis, and gingivostomatitis. There are two HSV serotypes that are closely related antigenically. HSV type 2 is more commonly associated with genital tract and neonatal infections, while HSV type 1 is more commonly associated with infections of non-genital sites. Specific typing is not usually required for diagnosis or treatment. The mean time to seroconversion using the type specific assay is 25 days. The performance of this assay has not been established for use in a pediatric population, for neonatal screening, or for testing of immunocompromised patients.


HIV-1/2 Antigen and Antibodies, Fourth Generation, with Reflexes

Clinical Use

  • Screen for and confirm HIV-1/HIV-2 infection, including acute HIV-1 infection
  • Differentiate HIV-1 from HIV-2 infection

 

IMPORTANT:  NOTE THIS IS A REFLUX TEST - The price charged for this test is only for the HIV Antigen and Antibody, 4th Generation Screen in step 1 below. If this test is “reactive” then Quest automatically runs the HIV-1/2 Antibody Differentiation test and, an additional charge of $74 will be charged for this test.  If the HIV-1/2 Antibody Differentiation is “indeterminate or nonreactive” then Quest automatically runs the HIV-1 RNA, Qualitative, TMA and an additional fee of $168 will be charged for this test.

Step 1 - Test HIV Antigen and Antibody, 4th Generation Screen is initially run

  • Nonreactive then result is Negative and no further testing (HIV-Infection unlikely)
  • Repeatedly reactive then Step 2

Step 2 - HIV-1/2 Antibody Differentiation (run if Step 1 is positive)

  • Reactive then interpret test results as HIV Infection (HIV-1, HIV-2 or undifferentiated)
  • Indeterminate or nonreactive then Step 3.

Step 3 - HIV-1 RNA, Qualitative, TMA (run if Step 2 is Indeterminate or Negative)

  • Negative then result is Negative (false positive) and (HIV-1 infection unlikely. Consider testing for HIV-2 DNA if clinically indicated)
  • Positive then interpret test results as Acute HIV-1 infection

This algorithm depicts the testing pathway of the HIV-1/2 Antigen and Antibodies, Fourth Generation, with Reflexes test. Although nonreactive results on the fourth-generation screening test and negative results on the HIV-1/HIV-2 differentiation test are consistent with an absence of infection, they may also represent samples collected before the development of detectable p24 antigen and HIV antibodies. Individual risk assessments may be helpful to determine the need for, and the frequency of, re-screening for patients with nonreactive/negative results.

The algorithm is provided for informational purposes only and is not intended as medical advice. A physician’s test selection and interpretation, diagnosis, and patient management decisions should be based on his/her education, clinical expertise, and assessment of the patient.

The HIV-1/2 Antigen and Antibodies, Fourth Generation, with Reflexes detects HIV p24 antigen in addition to HIV antibodies. Because HIV p24 antigen is detectable before seroconversion, fourth-generation assays can detect HIV-1 during acute infection; the inclusion of HIV-1 and HIV-2 antibodies allows detection after seroconversion, when p24 antigen becomes undetectable. Fourth-generation assays have >99.7% sensitivity and >99.3% specificity for HIV infection and can identify most (>80%) acute infections that would otherwise require nucleic acid testing for detection.6,7 In general, they can detect infection 0 to 20 days (median, 5-7 days) before third-generation immunoassays.5,8,9

Repeatedly reactive results on fourth-generation screening tests require confirmation with a supplemental test, such as an HIV-1/HIV-2 antibody differentiation assay. Differentiation between HIV-1 and HIV-2 antibodies can have treatment implications, as HIV-2 does not respond to some antiretroviral agents. Differentiation tests also tend to detect antibodies earlier than Western blots.  HIV-1/HIV-2 antibody differentiation tests do not detect acute infection. HIV RNA testing is thus needed to resolve infection status in patients with positive results on the fourth-generation assay but negative results on the antibody differentiation test.


Celiac disease is a multigenic immune-mediated enteropathy triggered by dietary proteins, commonly known as glutens, present in wheat, barley, and rye. Varied clinical manifestations begin either in childhood or adult life. Its prevalence in the united states ranges from 0.5 to 1%. Celiac disease is strongly associated with the HLA genetic region. Approximately 90% of celiac patients express the HLA-DQ2 molecule. Most of the DQ2 negative patients express the HLA-DQ8 molecule. Gluten peptides presented by these HLA molecules induce an abnormal mucosal immune response and tissue damage. The HLA-DQ molecules are heterodimers of an alpha and a beta chain. The beta chain of HLA-DQ2 is coded by HLA-DQB1*02 and of DQ8 by HLA-DQB1*0302. HLA-DQB1 genotyping allows clinicians to evaluate the genetic predisposition for celiac disease in a patient.

Elevated levels of homocysteine are observed in patients at risk for coronary heart disease and stroke.