• Bacterial Culture, Aerobic, Special

Encapsulated Haemophilus influenzae can be separated into 6 capsular serotypes, a-f. Most upper respiratory tract strains of H. influenzae are non-encapsulated and therefore non-typeable. Most severe infections are caused by H. influenzae strains belonging to the capsular serotype b. In this slide agglutination test, agglutination occurs when a suspension of the isolate reacts with serotype-specific antisera.

This test is approved for New York patient testing.

Specific soluble bacterial capsular polysaccharide antigens accumulate in CSF, serum, or urine. This is a presumptive latex agglutination test for the direct qualitative detection of bacterial antigen. Visible agglutination occurs when a sample containing a bacterial antigen reacts with specific polyclonal antibody-coated latex particles. This test is not intended as a substitute for a properly performed Gram stain and bacterial culture. Confirmatory diagnosis of bacterial meningitis is only possible with appropriate culture procedures. Samples with extremely low levels of antigen may yield negative results. Nonspecific reactions are known to occur, especially with urine samples. Cross-reactions and interference by rheumatoid factor and other substances have also been reported.

This test is approved for New York patient testing.

Antibody to polyribosylribitol phosphate (PRP), the capsular polysaccharide of Haemophilus influenzae type b, is measured in mcg/mL, based on correlations with a reference Farr immunoprecipitation assay (RIA). A significant increase in the PRP antibody level between pre- and post-immunization sera is considered evidence of effective vaccination.

This test is approved for New York patient testing.

 Vaccine Response Testing

A significant increase in the PRP antibody level between pre- and post-immunization sera is considered evidence of effective vaccination.

Two major groups of hantaviruses are recognized based on clinical presentation. The first group includes Sin Nombre Virus, which causes hantavirus pulmonary syndrome, a severe and possibly fatal form of acute respiratory distress. A second group of hantaviruses (including Seoul, Hantaan, Dobrava, and Puumala viruses) causes hemorrhagic fever with renal syndrome, a condition not typically seen in the United States. Sera are initially screened for IgG and IgM antibodies recognizing the nucleocapsid protein common to all hantaviruses.
All screen IgM positive samples are then tested for SNV-specific IgM at an additional charge; further, any screen IgM positive samples that are also screen IgG positive are tested for SNV-specific IgG at an additional charge.
A positive result in the screening ELISA but a negative result in confirmatory assays may indicate reactivity to a hantavirus causing hemorrhagic fever with renal syndrome.

†This test was developed and its performance characteristics determined by Focus Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Performance characteristics refer to the analytical performance of the test.

This test is not approved for New York patient testing.

• Hepatitis B Virus (HBV) DNA, Quantitative, Real-Time PCR
• Hepatitis B Virus (HBV) Genotype, S and POL Gene
• Hepatitis Be Antibody, EIA
• Hepatitis Be Antigen, EIA
• Hepatitis Be Panel, EIA

• Hepatitis C (HCV) Viral RNA, Quantitative, Real-Time PCR
• Hepatitis C Virus RNA Genotype, LiPA
• Hepatitis C Virus RNA, Qualitative PCR

• Hepatitis D Antibody, Total
• Hepatitis D Antigen
• Hepatitis D Virus Antibody Panel, EIA
• Hepatitis D Virus RNA, Qualitative Real-Time PCR

Individuals infected with H. pylori strains expressing Cytotoxinassociated gene A (CagA) protein and/or Vacuolating-Cytotoxin A (VacA) protein are at increased risk for developing gastric or peptic ulcers and/or gastric carcinoma. Detection of antibodies to one or both of these proteins indicates infection with a highly pathogenic strain of H. pylori.

†This test was developed and its performance characteristics determined by Focus Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Performance characteristics refer to the analytical performance of the test.

This test is approved for New York patient testing.

Individuals infected with H. pylori strains expressing Cytotoxinassociated gene A (CagA) protein and/or Vacuolating-Cytotoxin A (VacA) protein are at increased risk for developing gastric or peptic ulcers and/or gastric carcinoma. Detection of antibodies to one or both of these proteins indicates infection with a highly pathogenic strain of H. pylori.

†This test was developed and its performance characteristics determined by Focus Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Performance characteristics refer to the analytical performance of the test.

This test is approved for New York patient testing.

Individuals infected with H. pylori strains expressing Cytotoxinassociated gene A (CagA) protein and/or Vacuolating-Cytotoxin A (VacA) protein are at increased risk for developing gastric or peptic ulcers and/or gastric carcinoma. Detection of antibodies to one or both of these proteins indicates infection with a highly pathogenic strain of H. pylori.

†This test was developed and its performance characteristics determined by Focus Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Performance characteristics refer to the analytical performance of the test.

This test is approved for New York patient testing.

Helicobacter pylori is detectable in nearly 100% of adult patients with a duodenal ulcer and about 80% of patients with gastric ulcer. An association with gastric cancer is now confirmed. A Gram stain will be performed on each specimen; a positive Gram stain has been reported to be up to 100% specific for H. pylori, a curved gram negative bacillus. When obtaining biopsy specimens, substances such as cimetidine and benzocaine, which inhibit the growth of H. pylori, should be avoided. Contamination of biopsy forceps with gluteraldehyde also inhibits growth. Cultures are held for up to 14 days.

This test is approved for New York patient testing.

The detection of Helicobacter pylori antigen in stool samples by enzyme immunoassay is a simple, non-invasive, highly sensitive and specific test. This assay indicates active infection with (antigen), not just exposure to (antibody), H. pylori. A test result can be used to diagnose active infection in symptomatic adult patients, as well as to monitor response during and post- therapy in adult patients. Successful eradication can be confirmed with a negative result at least 4 weeks following completion of therapy.

This test is approved for New York patient testing.

 Helicobacter Pylori Antibody Testing

See individual assay for description.

Panel Includes:

• Helicobacter pylori Antigen, EIA (stool)
• Helicobacter pylori IgA Antibody, ELISA
• Helicobacter pylori IgG Antibody, ELISA
• Helicobacter pylori IgM Antibody, ELISA

 Helicobacter Pylori Antibody Testing

This unit code has been inactivated.

Please see unit code 40550.

Please see the following technical sheet for more information:
 Helicobacter Pylori Antibody Testing

Gastric colonization of Helicobacter pylori has been implicated as a cofactor in the development of some cases of gastritis and peptic or duodenal ulcer. Gastroduodenal disease caused by H. pylori can be successfully treated with antimicrobial therapy. In some patients without detectable IgG antibody to H. pylori, determination of IgA levels may be useful in establishing H. pylori infection.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

This test is not approved for New York patient testing.

 Helicobacter Pylori Antibody Testing

 Helicobacter Pylori Antigen Testing

Gastric colonization by Helicobacter pylori has been implicated as a cofactor in the development of some cases of gastritis and peptic or duodenal ulcer. Gastroduodenal disease caused by H. pylori can be successfully treated with antimicrobial therapy. Eradication of H. pylori infection has been associated with decreasing IgG and IgA antibody levels to H. pylori. As IgG levels to H. pylori are encountered in a large percentage of adults, clinicians should be aware that age-related acquisition of H. pylori contributes to the age-related increase in the incidence of H. pylori antibody. As a result this test is best used to rule out H. pylori infection when the antibody results are negative.

This test is approved for New York patient testing.

 Helicobacter Pylori Antibody Testing

 Helicobacter Pylori Antigen Testing

See individual assay for description.

Panel Includes:

• Helicobacter pylori IgA Antibody, ELISA
• Helicobacter pylori IgG Antibody, ELISA

 Helicobacter Pylori Antibody Testing

 Helicobacter Pylori Antigen Testing

See individual assay for description.

Panel Includes:

• Helicobacter pylori IgG Antibody, ELISA
• Helicobacter pylori IgA Antibody, ELISA
• Helicobacter pylori IgM Antibody, ELISA

 Helicobacter Pylori Antibody Testing

 Helicobacter Pylori Antigen Testing

See individual assay for description.

Panel Includes:

• Helicobacter pylori IgG Antibody, ELISA
• Helicobacter pylori IgA Antibody, ELISA
• Helicobacter pylori IgM Antibody, ELISA

Gastric colonization by Helicobacter pylori has been implicated as a cofactor in the development of some cases of gastritis and peptic or duodenal ulcer. Gastroduodenal disease caused by H. pylori can be successfully treated with antimicrobial therapy. The clinical utility of H. pylori IgM antibody measurement has not been clearly established.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

This test is not approved for New York patient testing.

 Helicobacter Pylori Antibody Testing

 Helicobacter Pylori Antigen Testing

• Antimicrobial Susceptibility, Helicobacter pylori, MIC Panel

If HBV DNA is detected in the qualitative assay, the specimen will reflex to HBV DNA Quantitative, PCR (Focus Unit Code 47985) for an additional charge.

This test is approved for New York patient testing.

Quantitative measurement of HBV DNA viral load is based on the real-time PCR amplification and detection of HBV genomic DNA in the presence of a quantitative standard. The quantitative range of this assay is 29 to 110,000,000 HBV IU/mL (169 to 640,200,000 HBV copies/mL).

This test is approved for New York patient testing.

This assay determines the following: (1) HBV genotype (types A-G), (2) the presence or absence of HBV mutations associated with resistance to antiviral agents, and (3) the presence or absence of mutations in the HBV precore and basal core promoter regions.

†This test was developed and its performance characteristics determined by Focus Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Performance characteristics refer to the analytical performance of the test.

Test performed at Quest Diagnostics Nichols Institute.

The Hepatitis Be antigen (HBeAg) is an integral component of the Hepatitis B virus (HBV) core particle. HBeAg is only detectable when hepatitis B surface antigen (HBsAg) is present and indicates high concentrations of HBV particles in the specimen.

This test is approved for New York patient testing.

Hepatitis B virus (HBV) DNA PCR is a highly sensitive method to detect the presence of HBV DNA in clinical specimens.

This test is approved for New York patient testing.

The appearance of hepatitis Be antibody (HBeAb) is associated with a decrease in hepatitis B virus (HBV) particles in the circulation of chronic hepatitis B carriers. The appearance of HBeAb occurs after hepatitis B core antibody (HBcAb) but prior to hepatitis B surface antibody (HBsAb) in normal convalescence.

This test is approved for New York patient testing.

See individual assay for description.

Panel Includes:

• Hepatitis Be Antibody, EIA
• Hepatitis Be Antigen, EIA

Quantitative measurement of HCV RNA viral load is determined using the FDA-approved Roche COBAS® AmpliPrep/COBAS® TaqMan HCV Test. The quantitative range of the assay is 43 to 69,000,000 HCV IU/mL (1.63 log10 to 7.84 log10).

This test is approved for New York patient testing.

This unit code has been inactivated.

Please see unit code 43005.

The HCV genotype determined by this test is based upon reverse transcription of genomic HCV RNA in the sample followed by PCR amplification and hybridization of the amplified material to oligonucleotide probes specific for different HCV genotypes. This test can distinguish HCV genotypes 1, 1a, 1b, 2, 2a/c, 2b, 3, 3a, 3b, 3c, 4, 4a, 4b, 4c/d, 4e, 4f, 4h, 5a, 6a, and 10a.

Test performed at Quest Diagnostics Nichols Institute.

Hepatitis D virus (HDV) is an RNA virus whose transmission is dependent on associated hepatitis B viral infection.

This test is not approved for New York patient testing.

See individual assay for description.

Panel Includes:

• Hepatitis D Antibody Total
• Hepatitis D Virus (HDV) IgM Antibody, EIA

This test is approved for New York patient testing.

This assay is performed using the FDA-cleared AMPLICOR^® Hepatitis C Virus (HCV) Test, version 2.0, manufactured and distributed by Roche Diagnostics Systems, Inc. The AMPLICOR HCV Test, v2.0, is an in vitro diagnostic, nucleic-acid amplification test for qualitative detection of HCV RNA in human serum or plasma from blood collected in EDTA. The AMPLICOR HCV Test, v2.0, is indicated for patients who have evidence of liver disease and antibody evidence of HCV infection, and who are suspected to be actively infected with HCV.

Test performed at Quest Diagnostics Nichols Institute.

Hepatitis D virus (HDV) infection occurs in association with HBV infection. A positive result for HDV total antibody may indicate either acute or chronic HDV infection. HDV antibodies appear transiently during acute infection, and typically disappear with resolution of the infection. In contrast, HDV antibodies usually persist in chronic infection.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

This test is approved for New York patient testing.

HDV infection occurs only in association with HBV infection. Detection of HDV IgM indicates active HDV replication due to either infection or reactivation of chronic infection.

This test is approved for New York patient testing.

HDV infection occurs only in association with HBV infection. Acute HDV infection reflects either HDV acquisition at the time of acute HBV infection (coinfection), or recent exposure to HDV in a patient with chronic HBV infection (superinfection). HDV antigen is detected transiently during the early phase of acute HDV infection, but typically disappears as HDV-specific antibodies arise.

This test is approved for New York patient testing.

HEV infection is responsible for some cases of non-A, non-B, non-C hepatitis. Found primarily in Asia, Africa, Mexico, and Central America, HEV is mainly transmitted via contaminated water.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

This test is approved for New York patient testing.

HEV infection is responsible for some cases of non-A, non-B, non-C hepatitis. Found primarily in Asia, Africa, Mexico, and Central America, HEV is mainly transmitted via contaminated water.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

This test is approved for New York patient testing.

HEV infection is responsible for some cases of non-A, non-B, non-C hepatitis. Found primarily in Asia, Africa, Mexico, and Central America, HEV is mainly transmitted via contaminated water.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

This test is approved for New York patient testing.

Real-time reverse transcription-PCR is utilized to detect HGV RNA genomes in serum and plasma.

This test is not approved for New York patient testing.

The combination of centrifugation with sensitive monoclonal antibody staining techniques has both increased the rate of isolation as compared with conventional cultures and reduced the turn-around time to 48 hours. Serotyping of HSV isolates is done routinely.

This test is approved for New York patient testing.

Smears are stained with fluorescent monoclonal antibodies that detect the presence of HSV in specimens. Sensitivity of this test is 60-80%.

This test is approved for New York patient testing.

The detection of HSV-1 and HSV-2 DNA is based upon the real-time amplification, detection and differentiation of specific HSV-1 and HSV-2 genomic DNA sequences by PCR from total DNA extracted from the specimen. PCR is considered the standard for detecting viral nucleic acids in CSF.

This test is approved for New York patient testing.

See individual assay for description.

Panel Includes:

• Enterovirus RNA, Qualitative Real-Time PCR
• Herpes Simplex Virus (HSV) 1/2 Detection and Differentiation, PCR

The ACIF procedure measures antibody capable of activating complement; thus, both IgG and IgM antibody to HSV are detected. This procedure detects both type-common and type-specific HSV antibodies and therefore does not discriminate HSV-1 and HSV-2 antibodies. Elevated titers to both HSV-1 and HSV-2 may represent crossreactive HSV antibodies or exposure to both HSV-1 and HSV-2.

This test is available for New York patient testing.

Detection of intrathecally-produced organism-specific antibodies in CSF indicates central nervous system infection. However, serum levels of organism-specific antibodies, blood-brain barrier integrity, and possible CSF contamination by blood should be considered when assessing CSF results.

This test is available for New York patient testing.

See individual assay for description.

Panel Includes:

• Herpes Simplex Virus (HSV) 1/2 Antibody ACIF
• Herpes Simplex Virus (HSV) 1/2 IgM Panel, IFA

The HSV IgM ELISA detects type-common as well as type-specific IgM antibodies; thus, the type-specificity of any HSV IgM antibodies detected cannot be reliably determined. All samples giving an equivocal or positive IgM ELISA result are confirmed by an IFA procedure. As with the HSV IgM ELISA, however, IgM reactivity in the IFA is not type-specific.

This test is approved for New York patient testing.

 HerpeSelect^® Type-Specific HSV-1 and HSV-2 IgG Antibody Differentiation

The detection of HSV-1 and HSV-2 DNA is based upon the real-time amplification, detection and differentiation of specific HSV-1 and HSV-2 genomic DNA sequences by PCR from total DNA extracted from the specimen. The quantitative range of this assay is 100 - 2,000,000 copies/mL.

This test is available for New York patient testing.

Classically, HSV-1 infections are acquired in early childhood and are often asymptomatic or subclinical, but may produce oral lesions while HSV-2 is often acquired post-adolescence and manifests as genital infections with lesions. Current adult sexual behavior has allowed for oral HSV-2 infections and genital HSV-1 infections that are indistinguishable from the classic infections without identification of the virus. This assay uses cell culture methods that allow for HSV-1 and HSV-2 growth and isolation followed by a specific antiserum immunofluoresence assay for virus identification.

This test is approved for New York patient testing.

Differentiation of HSV-1 from HSV-2 IgG antibodies can be effectively accomplished using the HerpeSelect^® HSV-1 and HSV-2 IgG immunoblot assay, which utilizes recombinant type-specific HSV glycoproteins (gG antigens).

This test is approved for New York patient testing.

 HerpeSelect^® Type-Specific HSV-1 and HSV-2 IgG Antibody Differentiation

The HerpeSelect^® test system utilizes recombinant type-specific HSV-1 and HSV-2 antigens to detect type-specific IgG antibodies. Detection of IgG to both HSV-1 and HSV-2 in a single specimen therefore indicates dual infection by HSV-1 and HSV-2. In-house validation studies revealed a sensitivity of 100% for both the HSV 1 IgG ELISA and the HSV-2 IgG ELISA when compared to Western blot; specificity was 98% for both assays.

This test is approved for New York patient testing.

 HerpeSelect^® Type-Specific HSV-1 and HSV-2 IgG Antibody Differentiation

The HSV IgM ELISA detects type-common as well as type-specific IgM antibodies; thus, the type-specificity of any HSV IgM antibodies detected cannot be reliably determined. Specimens exhibiting equivocal or positive IgM ELISA results are confirmed by HSV IgM 1/2 IFA (Focus Unit Code 40545) for an additional charge. As with the HSV IgM ELISA, however, IgM reactivity in the IFA is not type-specific.

This test is approved for New York patient testing.

The IFA procedure for measuring IgM antibodies to HSV-1 and HSV-2 will detect both type-common and type-specific HSV antibodies. Thus, elevated titers to both HSV-1 and HSV-2 may represent crossreactive HSV antibodies rather than exposure to both HSV-1 and HSV-2.

This test is approved for New York patient testing.

Detection of intrathecally-produced organism-specific antibodies in CSF indicates central nervous system infection. However, serum levels of organism-specific antibodies, blood-brain barrier integrity, and possible CSF contamination by blood should be considered when assessing CSF results.

This test is available for New York patient testing.

This test is designed to further characterize samples giving low positive or other unexpected results in HSV-2 type-specific IgG assays.
Note: Specimens submitted from another lab for inhibition studies must include the index value of the initial type-specific ELISA test. Inhibition studies are not performed on samples with equivocal or negative results.

This test is approved for New York patient testing.

Human herpesvirus 6 (HHV-6) is the cause of the common childhood disease exanthem subitum (roseola infantum) and can reactivate after primary infection in immunocompromised adults and children. Focus performs this assay using primers and probe detecting both variants A and B of HHV-6.

This test is not approved for New York patient testing.

If HHV-6 DNA is detected in the qualitative assay, the specimen will reflex to Herpesvirus 6 Quantitative PCR (Focus Unit Code 43660) for an additional charge. The quantitative range if reflexed is 500 - 2,000,000 HHV-6 DNA copies/mL.

This test is not approved for New York patient testing.

Human herpesvirus 6 (HHV-6) is the cause of the common childhood disease exanthem subitum (roseola infantum) and can reactivate after primary infection in immunocompromised adults and children. Focus performs this assay using primers and probe detecting both variants A and B of HHV-6. Quantification of HHV-6 DNA is based upon the real-time PCR amplification and detection of HHV-6 genomic DNA. The quantitative range of this assay is 500 to 2,000,000 HHV-6 DNA copies/mL.

This test is not approved for New York patient testing.

Human herpesvirus 6 (HHV-6) is found in peripheral blood leukocytes and is considered the agent of roseola. The normal prevalence of HHV-6 antibody is high. Nearly 100% of the population will demonstrate antibody at midlife with titers declining with increasing age. Immunofluorescence assays are used for detection of antibody recognizing HHV-6. Crossreactions with other herpes viruses, i.e., Cytomegalovirus and Herpes Simplex have not been found. In order to serologically demonstrate primary infection, it is necessary to detect a significant change in titer.

†This test was developed and its performance characteristics determined by Focus Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Performance characteristics refer to the analytical performance of the test.

This test is approved for New York patient testing.

Human herpesvirus-6 (HHV-6) is considered the agent of roseola. Detection of HHV-6 IgM is indicative of acute infection.

†This test was developed and its performance characteristics determined by Focus Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Performance characteristics refer to the analytical performance of the test.

This test is approved for New York patient testing.

Human herpesvirus 6 (HHV-6) infects peripheral blood leukocytes, and is considered the agent of roseola. The normal prevalence of HHV-6 antibody is high; nearly 100% of the population will demonstrate antibody at midlife with titers declining in old age. Immunofluorescence assays are used for serological detection of HHV-6. Crossreactions with other Herpes viruses, i.e., Cytomegalovirus and Herpes Simplex have not been found. In order to demonstrate primary infection, it is necessary to detect a significant change in titer.

†This test was developed and its performance characteristics determined by Focus Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Performance characteristics refer to the analytical performance of the test.

This test is approved for New York patient testing.

Human herpesvirus-7 (HHV-7), a close relative of HHV-6, is found in >85% of the population, with transmission occurring in early childhood. Like HHV-6, HHV-7 is a cause of exanthum subitum (roseola infantum). Due to the ubiquitous nature of HHV-7 infection, >80% of individuals in the general population exhibit HHV-7 IgG titers >=1:20; however, only 5% of these individuals exhibit titers >1:80. Thus, single HHV-7 IgG titers >=1:160 are suggestive of recent HHV-7 infection. A four-fold change in titer between acute and convalescent sera is also suggestive of recent HHV-7 infection. For comparison of acute and convalescent sera, titers starting at 1:20 can be measured upon request.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

This test is not approved for New York patient testing.

HHV-7 is closely related to HHV-6 and CMV, and can cause reactivation disease in transplant patients or other immune-compromised individuals. Quantification of HHV-7 DNA is based upon the real-time PCR amplification and detection of HHV-7 genomic DNA. The quantitative range of this assay is 500 HHV-7 DNA copies/mL (2.7 log10) to 10,000,000 copies/mL (7.0 log10).

This test is not approved for New York patient testing.

Human Herpesvirus 7 (HHV-7), a close relative of HHV-6, is found in >85% of the population, with transmission occurring in early childhood. Like HHV-6, HHV-7 is a cause of exanthum subitum (roseola infantum). Due to the ubiquitous nature of HHV-7 infection, >80% of individuals in the general population exhibit HHV-7 IgG titers >=1:20; however, only 5% of these individuals exhibit titers >1:80. Thus, HHV-7 IgG titers >=1:160 are suggestive of recent HHV-7 infection. Detection of HHV-7 specific IgM is also indicative of recent infection.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

This test is not approved for New York patient testing.

Human Herpesvirus 7 (HHV-7) has been identified as an etiologic agent of exanthem subitum. Detection of HHV-7-specific IgM provides serologic evidence of acute infection.

This test is not approved for New York patient testing.

Human herpesvirus type 8 (HHV-8) is a DNA virus that was originally detected in biopsies of individuals with AIDS-associated Kaposi's Sarcoma (KS). Experimental evidence suggests that HHV-8 is the etiological agent of KS.

This test is approved for New York patient testing.

Human herpesvirus type 8 (HHV-8) is a DNA virus that was originally detected in biopsies of individuals with AIDS-associated Kaposi's Sarcoma (KS). Experimental evidence suggests that HHV-8 is the etiological agent of KS. If HHV-8 DNA is detected in the qualitative assay, the specimen will reflex to the HHV-8 Quantitative PCR (Focus Unit Code 45700) for an additional charge.

This test is not approved for New York patient testing.

Human herpesvirus type 8 (HHV-8) is a DNA virus that was originally detected in biopsies of individuals with AIDS-associated Kaposi's Sarcoma (KS). Experimental evidence suggests that HHV-8 is the etiological agent of KS. This assay detects viral loads down to <1000 copies/mL.

This test is not approved for New York patient testing.

Human herpesvirus-8 (HHV-8), also known as Kaposi's Sarcoma Herpesvirus (KSHV), is found in most cases of Kaposi's Sarcoma (KS), including classic KS as well as AIDS-related KS. HHV-8 has also been detected in B-cell lymphomas in the abdominal cavity. IgG antibodies recognizing HHV-8 are found in >80% of KS patients and approximately 30% of HIV-seropositive individuals without KS, but less than 5% of healthy blood donors.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

This test is approved for New York patient testing.

• Anaplasma phagocytophilum and Ehrlichia chaffeensis Antibody Panel
• Anaplasma phagocytophilum Antibodies (IgG, IgM)
• Anaplasma Phagocytophilum DNA, Qualitative Real-Time PCR

• Hepatitis G Virus (HGV) RNA, Qualitative, RT-PCR

• Herpesvirus 6 (HHV-6) DNA, Qualitative Real-Time PCR
• Herpesvirus 6 Antibodies (IgG, IgM)
• Herpesvirus 6 Antibody (IgG)
• Herpesvirus 6 Antibody (IgM)

• Herpesvirus 7 IgG Antibody, IFA
• Herpesvirus 7 IgM Antibody, IFA

• Herpes Virus 8 DNA, Qualitative Real-Time PCR
• Herpesvirus 8 IgG Antibody, IFA

Histone antibodies can be used to verify the diagnosis of drug-induced lupus caused by drugs such as procainamide and hydralazine. Histone antibodies are present in drug-induced lupus (96%), idiopathic SLE (50%), and occasionally, other collagen vascular diseases. Histone antibody in drug-induced lupus is the only specific anti-nuclear antibody detected; therefore the lack of histone antibody or the presence of other specific anti-nuclear antibodies makes the diagnosis of drug-induced lupus unlikely.

Test performed at Quest Diagnostics Nichols Institute.

The detection of Histoplasma capsulatum DNA is based upon the real-time amplification and detection of specific H. capsulatum genomic DNA sequences by PCR.

This test is not approved for New York patient testing.

Conventional laboratory identification methods used to identify Histoplasma capsulatum include growth on fungal media, growth rate, and colonial and microscopic morphology. Once the organism begins to grow in culture, it may take many days or weeks of additional growth before the characteristic microscopic appearance of sportulation is observed. This test utilizes a chemiluminescent-labeled, single-stranded DNA probe that hybridizes to specific ribosomal RNA sequences that are unique to H. capsulatum. Colonies are identified as soon as growth is visible, with no need to wait for sportulation to occur. The sensitivity and specificity of this test both approach 100%.

This test is approved for New York patient testing.

This assay measures total antibodies to H. capsulatum with approximately 90% sensitivity and 85% specificity compared to immunodiffusion (ID). Samples exhibiting equivocal or positive results are confirmed by Histoplasma ID (Focus Unit Code 40575) for an additional charge.

This test is approved for New York patient testing.

Complement-fixation (CF) titers >=1:8 are generally considered evidence indicative of histoplasmosis. Higher titers increase the probability of infection. However, positive titers are also seen with fungal infections other than histoplasmosis, and confirmation of antibody specificity with immunodiffusion procedures is recommended. Changing titers are useful both in diagnosis and in assessment of treatment efficacy.

This test is approved for New York patient testing.

Detection of intrathecally-produced organism-specific antibodies in CSF indicates central nervous system infection. However, serum levels of organism-specific antibodies, blood-brain barrier integrity, and possible CSF contamination by blood should be considered when assessing CSF results.

This test is approved for New York patient testing.

See individual assay for description.

Panel Includes:

• Histoplasma Antibody, Complement Fixation, Serum
• Histoplasma Antibody, Immunodiffusion, Serum

See individual assay for description.

Panel Includes:

• Histoplasma Antibody, Complement Fixation, CSF
• Histoplasma Antibody, Immunodiffusion, CSF

See individual assays for description.

Panel Includes:

• Histoplasma Antibody, Complement Fixation, Serum
• Histoplasma Antibody, Immunodiffusion, Serum
• Histoplasma capsulatum Antibody, ELISA

Positive immunodiffusion reactions involve one or more specific precipitin bands. Of these bands the first to appear in active histoplasmosis is the "M" band, which is seen in approximately 70% of proven cases. This band is also seen in some patients with past infections and in 20% of those with recent histoplasmin skin testing. The "H" band is usually seen in active and progressive histoplasmosis and almost always in the presence of the "M" band, although it is found much less often (approximately 10% of proven cases).

This test is approved for New York patient testing.

Detection of intrathecally-produced organism-specific antibodies in CSF indicates central nervous system infection. However, serum levels of organism-specific antibodies, blood-brain barrier integrity, and possible CSF contamination by blood should be considered when assessing CSF results.

This test is available for New York patient testing.

This unit code has been inactivated.

Please see unit code 40085.

This unit code has been inactivated.

Please see unit code 42955.

This unit code has been inactivated.

Please see unit code 40085.

This unit code has been inactivated.

Please see unit code 40085.

This assay detects mutations in the HIV-1 reverse transcriptase (RT) and protease (Pr) genes and uses proprietary algorithms to interpret the potential for resistance to antiviral agents. The entire protease gene and codons 1-400 of the reverse transcriptase gene are sequences to identify mutations. A minimum HIV-1 viral load of 600 copies/mL is required for HIV-1 genotyping using this assay.

Test performed at Quest Diagnostics Nichols Institute.

See individual assay for description.

Panel Includes:

• HIV-1 IgG Antibody, Western Blot
• HIV Direct Antigen (ICD) Detection, ELISA

This assay is a highly specific and sensitive method used to detect the integrated (proviral) form of HIV-1 DNA in clinical specimens.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

The measurement of HIV p24 (core) antigen is performed by the Immune Complex Dissociation (ICD) modification of the standard p24 antigen assay. This modification results in a significant increase in the sensitivity of the p24 antigen assay. All specimens found positive are confirmed by neutralization for an additional charge. Quantitation of p24 antigen has been shown to be useful for detection of circulating, replicating, as well as nonviable HIV. The measurement of p24 antigenemia using the ICD modification may be of significant value for the detection of early infection and as a marker of disease progression and therapeutic response. Furthermore the p24/ICD assay has shown significant value for the early detection of HIV infection in neonates and may supplement other diagnostic tests for neonatal infections, such as HIV-1 PCR. Reactive specimens are confirmed by a neutralization method for an additional charge.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

This test is not approved for New York patient testing.

The measurement of HIV-1 p24 (core) antigen is performed by the Immune Complex Dissociation (ICD) modification of the standard p24 antigen assay. This modification results in a significant increase in the sensitivity of the p24 antigen assay. Reactive specimens are confirmed by a neutralization method for an additional charge.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

This test is not approved for New York patient testing.

The HIV p24 antigen detected by this method has not had the immune complexes dissociated; therefore, the antigen value represents the non-complexed p24 antigen level. All specimens found positive are confirmed by neutralization and charged accordingly. The measurement of the p24 (core) antigen has been shown to be useful in detecting circulating, replicating HIV, as well as nonviable HIV. The measurement of p24 can be used to: 1) diagnose early disease states, 2) correlate antigenemia with severity of disease, and 3) monitor effectiveness of therapy. Reactive specimens are confirmed by a neutralization method for an additional charge.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

This test is not approved for New York patient testing.

The HIV p24 antigen detected by this method has not had the immune complexes dissociated; therefore, the antigen value represents the non-complexed p24 antigen level. Reactive specimens are confirmed by a neutralization method for an additional charge.

*This test was performed using a kit that has not been cleared or approved by the FDA. The analytical performance characteristics of this test have been determined by Focus Diagnostics. This test should not be used for diagnosis without confirmation by other medically established means.

This test is not approved for New York patient testing.

Detection of intrathecally-produced organism-specific antibodies in CSF indicates central nervous system infection. However, serum levels of organism-specific antibodies, blood-brain barrier integrity, and possible CSF contamination by blood should be considered when assessing CSF results.

This assay is intended for specimens testing positive in a screening assay for HIV 1/2 antibodies.

This test is not approved for New York patient testing.

• HIV-1 Direct Antigen (ICD), ELISA (CSF)

The interpretative criteria employed are those proposed by the association of state and territorial public health directors and CDC (MMWR 38, no 5-7, 1989), whereby serum reactivity with two or more of the following antigens defines a positive result: p24, gp41, gp120/160. Sera reactive with less than two of these antigens and sera reactive with other antigens are reported as indeterminate.

This assay is intended for specimens testing positive in a screening assay for HIV 1/2 antibodies.

This test is approved for New York patient testing.

HIV-1 reverse transcriptase PCR (RT-PCR) is an ultra-sensitive method of accurately quantifying HIV-1 RNA in clinical plasma specimens. This assay is performed using an FDA-cleared assay with a reportable range of 48 - 10,000,000 HIV-1 RNA copies/mL.

Test performed at Quest Diagnostics Nichols Institute.

The HIV-1/2 EIA detects antibodies to both Human Immunodeficiency Virus type 1 (HIV-1) and type 2 (HIV-2). This assay utilizes recombinant HIV-1 and HIV-2 proteins and detects both IgG and IgM classes of antibodies; however the assay does not differentiate HIV-1 from HIV-2 infection. Specimens which are repeatedly reactive in the combination HIV-1/HIV-2 EIA will be confirmed using the testing algorithm suggested by the CDC (MMWR 41:RR12, 1992). HIV-Antibody Western blot will be performed for an additional charge.

This test is approved for New York patient testing.