IGENEX TEST RESULTS
EXPLANATION AND INTERPRETATION
The information below is to help physicians interpret the results of each diagnostic test we offer. Physicians should use this information in conjunction with a patient’s symptoms and medical history to determine the most accurate diagnosis.
Disclaimer: These tests were developed and its performance characteristics determined by IGeneX, Inc. It has not been cleared or approved by the FDA. The FDA has determined that such approval is not necessary. The test is used for clinical purposes and should not be regarded as investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing.
CHOOSE A TEST BELOW OR PRINT THE ENTIRE LIST
Please note that not all tests listed below are currently available from IGeneX. The Test Requisition Form has the most up to date information on available tests.
183 - Lyme IgG/IgM Serology
This test detects presence of specific IgG/IgM antibodies to B. burgdorferi.
Lyme Index Value (LIV) Interpretation
Positive: ≥ 1.2
Equivocal: ≥ 1.0 to < 1.2
Negative: < 1.0
Positive results with clinical history may indicate early stage Lyme disease. IgM may also be present in Stage II or Stage III Lyme disease. If Lyme disease is suspected in a patient exhibiting a negative result, an IgG and IgM Western Blot should be performed.
195 - Lyme IgM Serology
This test detects presence of specific IgM antibodies to B. burgdorferi.
Lyme Index Value (LIV) Interpretation
1.2: Positive. Confirmatory assays recommended.
0.8 and < 1.2: Equivocal. Retesting in two to four weeks recommended.
<0.8: Negative. Indicates IgM antibodies to B. burgdorferi not detected.
Positive results with clinical history may indicate early stage Lyme disease. IgM may also be present in Stage II or Stage III Lyme disease. If Lyme disease is suspected in a patient exhibiting a negative result, an IgG and IgM Western Blot should be performed.
200 - B. microti IgM & IgG IFA
The Babesia microti Indirect Immunofluorescent Antibody (IFA) test detects IgM and IgG antibodies to B. microti in human serum.
Results (titers)
IgM < 20: Negative (20 may or may not indicate active infection)
IgM 40: Indicates active infection
IgG < 40: Negative
IgG 40 to < 160: May or may not suggest active infection. In patients with previously high titers, such titers may indicate resolving infection.
IgG 160: Indicates active infection
Presence of both IgM and IgG together also indicates active infection. There is a low level of cross-reaction between B. microti and B. duncani IFA tests. In geographic regions where both species are present, we recommend that patient sera be tested by both B. microti and B. duncani IFA tests. A single negative IFA test does not rule out infection. Paired testing of acute and convalescent sera collected six to eight weeks apart is recommended for accurate diagnosis.
203 - E. chaffeensis (HME) IFA
HME (Human Monocytic Ehrlichiosis) immunofluorescent antibody test detects IgM and IgG antibodies to Ehrlichia chaffeensis, the causative agent of HME in human serum.
Results (titers)
IgM < 20: Negative. 20 may or may not indicate active infection.
IgM 40: Indicates active infection
IgG < 40: Negative
IgG 40 to < 160: May or may not suggest active infection. In patients with previously high titers, such titers may indicate resolving infection.
IgG 160: Indicates active infection
Presence of both IgM and IgG together also indicates active infection. Cross-reactions can occur among the Rickettsiaceae, including Rickettsia, Ehrlichia and Anaplasma. A single negative IFA test does not rule out infection. Paired testing of acute and convalescent sera collected six to eight weeks apart is recommended for accurate diagnosis.
206 - HGA (Anaplasma phagocytophilum) IgM & IgG IFA
The HGA (Human Granulocytic Anaplasmosis) immunofluorescent antibody test is used to detect IgM and IgG antibodies to Anaplasma phagocytophilum, the causative agent of HGA in human serum.
Results (titers)
IgM < 20: Negative. 20 may or may not indicate active infection.
IgM 40: Indicates active infection
IgG < 40: Negative
IgG 40 to < 160: May or may not suggest active infection. In patients with previously high titers, such titers may indicate resolving infection.
IgG 160: Indicates active infection
Presence of both IgM and IgG together also indicates active infection. Cross-reactions can occur among the Rickettsiaceae, including Rickettsia, Ehrlichia and Anaplasma. A single negative IFA test does not rule out infection. Paired testing of acute and convalescent sera collected six to eight weeks apart is recommended for accurate diagnosis.
280 - B. henselae PCR Whole Blood
The Bartonella henselae PCR test is an assay that detects B. henselae specific DNA in human specimen. B henselae rDNA fragments are hybrid- selected by probes, followed by PCR amplification of selected B. henselae rDNA. PCR products are detected with B. henselae specific probes in a dot blot assay. The primers and probes used for the selection of B. henselae rDNA fragments are designed from published small subunit ribosomal RNA sequences (NCBI GI:2828304).
Results (titers)
Positive: B. henselae rDNA detected
Negative: B. henselae rDNA not detected
281 - B. henselae PCR CSF
The Bartonella henselae PCR test is an assay that detects B. henselae specific DNA in human specimen. B henselae rDNA fragments are hybrid- selected by probes, followed by PCR amplification of selected B. henselae rDNA. PCR products are detected with B. henselae specific probes in a dot blot assay. The primers and probes used for the selection of B. henselae rDNA fragments are designed from published small subunit ribosomal RNA sequences (NCBI GI:2828304).
Results (titers)
Positive: B. henselae rDNA detected
Negative: B. henselae rDNA not detected
282 - B. henselae PCR Urine
The Bartonella henselae PCR test is an assay that detects B. henselae specific DNA in human specimen. B henselae rDNA fragments are hybrid- selected by probes, followed by PCR amplification of selected B. henselae rDNA. PCR products are detected with B. henselae specific probes in a dot blot assay. The primers and probes used for the selection of B. henselae rDNA fragments are designed from published small subunit ribosomal RNA sequences (NCBI GI:2828304).
Results (titers)
Positive: B. henselae rDNA detected
Negative: B. henselae rDNA not detected
285 - B. henselae IgM & IgG IFA
The Bartonella henselae indirect immunofluorescent antibody test is used to detect IgM and IgG antibodies to B. henselae in human serum.
Results (titers)
IgM < 20: Negative. 20 may or may not indicate active infection.
IgM 40: Indicates active infection
IgG < 40: Negative
IgG 40 to < 160: May or may not suggest active infection. In patients with previously high titers, such titers may indicate resolving infection.
IgG 160: Indicates active infection
Presence of IgM and IgG together also indicates active infection. A single negative IFA test does not rule out infection. Paired testing of acute and convalescent sera collected six to eight weeks apart is recommended for accurate diagnosis.
289 - Bartonella FISH
The Bartonella Fluorescent In Situ Hybridization (FISH) test detects bacteria of the Genus Bartonella including B. vinsonii, B. berkhoffii, B. henselae, and B. quintana in whole blood smears. Bartonella are rod shaped gram negative bacteria. The FISH test provides a significant increase in specificity over standard gram stain for the presence of Bartonella in whole blood smears.
Results
Positive: Fluorescing rod-shaped bodies detected in the smear.
Negative: Fluorescing rod-shaped bodies not detected in the smear.
325 - Lyme ImmunoBlot IgM
The Lyme ImmunoBlot IgM Test is a qualitative assay that detects B. burgdorferi strains and species IgM antibodies in human serum. Recombinant B. burgdorferi species antigens are sprayed at specific positions onto a nitrocellulose membrane and cut into strips. These strips are used to detect B. burgdorferi specific antibodies in patient serum.
IGeneX Criteria
Based on internal validation studies, IGeneX established the following criteria:
Positive: If two or more of the following 5 bands are present: 23, 31, 34, 39 and 41kDa
Negative: Any profile that does not meet positive criteria
CDC/NYS Criteria
Positive: If 2 of the following 3 bands are present: 23, 39, and 41kDa
Negative: Any profile that does not meet the positive criteria
Limitation: Positive ImmunoBlot result with 31 and/or 34kDa may be present after Lyme vaccination in uninfected persons. Viral antibodies cross react with the 93kDa antigen. A positive result suggests exposure to B. burgdorferi. For diagnostic purposes, immunoblot test results should be used in conjunction with clinical symptoms and other evidence available to the diagnosing physician. If only one of the following bands: 23, 31, 39kDa is present or if one or more of these bands are indeterminate on the ImmunoBlot, testing with another method or retesting after 6-8 weeks is recommended.
335 - Lyme ImmunoBlot IgG
The Lyme ImmunoBlot IgG Test is a qualitative assay that detects B. burgdorferi strains and species IgG antibodies in human serum. Recombinant B. burgdorferi species antigens are sprayed at specific positions onto a nitrocellulose membrane and cut into strips. These strips are used to detect B. burgdorferi specific antibodies in patient serum.
IGeneX Criteria
Based on internal validation studies, IGeneX established the following criteria:
Positive: If two or more of the following bands are present: 23, 31, 34, 39, 41 and 93 kDa
Negative: Any profile that does not meet positive criteria
CDC/NYS Criteria
Positive: If 5 of the following 10 bands are present: 18, 23, 28, 30, 39, and 41, 45, 58, 66 and 93kDa
Negative: Any profile that does not meet the positive criteria
Limitation: Positive ImmunoBlot result with 31 and/or 34kDa may be present after Lyme vaccination in uninfected persons. Viral antibodies cross react with the 93kDa antigen. A positive result suggests exposure to B. burgdorferi. For diagnostic purposes, immunoblot test results should be used in conjunction with clinical symptoms and other evidence available to the diagnosing physician. If only one of the following bands: 23, 31, 34, 39 and 93kDa is present or if one or more of these bands are indeterminate on the ImmunoBlot, testing with another method or retesting after 6-8 weeks is recommended.
345 - TBRF ImmunoBlot IgM
The TBRF IgM ImmunoBlot Test is a qualitative immunoblot assay that detects IgM antibodies in human serum to the following TBRF associated Borrelia species: B. miyamotoi, B. hermsii, B. turicatae and B. coriaceae. Recombinant TBRF Borrelia antigens are sprayed at specific positions onto nitrocellulose membrane and cut into strips. These strips are used to detect TBRF Borrelia specific antibodies in patient serum.
Results
Positive: If two TBRF Borrelia specific bands are present.
Indeterminate: If one TBRF Borrelia specific bands is present.
Negative: Any profile that does not meet the positive or indeterminate criteria.
Limitation: A positive result suggests exposure to TBRF Borrelia. For diagnostic purposes, immunoblot test results should be used in conjunction with clinical symptoms and other evidence available to the diagnosing physician. If the test result is indeterminate, testing with another method or retesting in 6-8 weeks is recommended.
350 - Bartonella IgXSpot
The Bartonella IGXSpot is an Enzyme-Linked ImmunoSpot assay that detects human T cells reactive to Bartonella specific antigens in vitro. It is well documented that both humoral and cellular immune responses develop in Bartonella infection. The cellular immune response develops much earlier than humoral response in most patients infected with Bartonella. In some patients sero-conversion from cellular to humoral response does not occur or occurs much later in disease; and in some patients with chronic form of the disease, the humoral response is poor. Thus the Bartonella IGXSpot test is recommended for detection of very early and/or late Bartonella infection; and in seronegative patient’s whole blood samples.
Results
Positive: >3 CFU
Negative: <2 CFU
Limitation: For diagnostic purposes, the IGXSpot test results should be used in conjunction with clinical symptoms and other evidence available to the diagnosing physician. If the test result is negative, testing with another method is recommended. Depending on the stage of the disease patients can have either humoral or cellular immune response to infection. Thus, it is advisable to perform Bartonella species Western Blot IgM and IgG tests with IGXSpot test.
355 - TBRF ImmunoBlot IgG
The TBRF IgG ImmunoBlot Test is a qualitative immunoblot assay that detects IgG antibodies in human serum to the following TBRF associated Borrelia species: B. miyamotoi, B. hermsii, B. turicatae and B. coriaceae. Recombinant TBRF Borrelia antigens are sprayed at specific positions onto nitrocellulose membrane and cut into strips. These strips are used to detect TBRF Borrelia specific antibodies in patient serum.
Results
Positive: If two TBRF Borrelia specific bands are present.
Indeterminate: If one TBRF Borrelia specific bands is present.
Negative: Any profile that does not meet the positive or indeterminate criteria.
Limitation: A positive result suggests exposure to TBRF Borrelia. For diagnostic purposes, immunoblot test results should be used in conjunction with clinical symptoms and other evidence available to the diagnosing physician. If the test result is indeterminate, testing with another method or retesting in 6-8 weeks is recommended.
374 - Bartonella ImmunoBlot IgM
The Bartonella IgM ImmunoBlots are designed to detect IgM antibodies to Bartonella species including Bartonella henselae, B. quintana, B. elizabethae and B. vinsonii antigens in serum of patient suspected of having Bartonella infection. For diagnostic purposes, the Bartonella ImmunoBlot test results should be used in conjunction with clinical symptoms and other evidence available to the diagnosing practitioner.
Results
Positive: If two Bartonella specific bands are present
Indeterminate: If one Bartonella specific band is present
Limitation: A positive result suggests exposure to Bartonella. For diagnostic purposes, immunoblot test results should be used in conjunction with clinical symptoms and other evidence available to the diagnosing physician. If the test result is indeterminate, testing with another method or retesting in 6-8 weeks is recommended.
384 - Bartonella ImmunoBlot IgG
The Bartonella IgG ImmunoBlots are designed to detect IgG antibodies to Bartonella species including Bartonella henselae, B. quintana, B. elizabethae and B. vinsonii antigens in serum of patient suspected of having Bartonella infection. For diagnostic purposes, the Bartonella ImmunoBlot test results should be used in conjunction with clinical symptoms and other evidence available to the diagnosing practitioner.
Results
Positive: If two Bartonella specific bands are present
Indeterminate: If one Bartonella specific band is present
Limitation: A positive result suggests exposure to Bartonella. For diagnostic purposes, immunoblot test results should be used in conjunction with clinical symptoms and other evidence available to the diagnosing physician. If the test result is indeterminate, testing with another method or retesting in 6-8 weeks is recommended.
450 - Lyme Multiplex PCR Urine
The Lyme Multiplex PCR test is a 3 step amplified nucleic acid assay that detects Borrelia burgdorferi specific DNA sequences from Osp A plasmid and flagellin genomic genes, in clinical specimens. The gene fragments are first selected with specific probes. Then the DNA is amplified using specific primers. Lastly, the amplified products are detected by hybridization to specific probes in a dot-blot assay. The test also detects DNA to other Borrelia: B. afzeli, B. andersonii, B. garinii and B. mayonii.
Results
Genomic Positive: B. burgdorferi DNA detected.
Negative: B. burgdorferi DNA not detected.
Plasmid Positive: B. burgdorferi DNA detected.
Negative: B. burgdorferi DNA not detected.
Sample is considered positive if either genomic or plasmid is positive.
Limitation: The diagnostic value of a negative serum/urine/blood PCR result for Borrelia species is questionable because the number of organisms in serum/urine/blood is often low or nonexistent in patients with Lyme disease.
453 - Lyme Multiplex PCR Serum
The Lyme Multiplex PCR test is a 3 step amplified nucleic acid assay that detects Borrelia burgdorferi specific DNA sequences from Osp A plasmid and flagellin genomic genes, in clinical specimens. The gene fragments are first selected with specific probes. Then the DNA is amplified using specific primers. Lastly, the amplified products are detected by hybridization to specific probes in a dot-blot assay. The test also detects DNA to other Borrelia: B. afzeli, B. andersonii, B. garinii and B. mayonii.
Results
Genomic Positive: B. burgdorferi DNA detected.
Negative: B. burgdorferi DNA not detected.
Plasmid Positive: B. burgdorferi DNA detected.
Negative: B. burgdorferi DNA not detected.
Sample is considered positive if either genomic or plasmid is positive.
Limitation: The diagnostic value of a negative serum/urine/blood PCR result for Borrelia species is questionable because the number of organisms in serum/urine/blood is often low or nonexistent in patients with Lyme disease.
456 - Lyme Multiplex PCR Whole Blood
The Lyme Multiplex PCR test is a 3 step amplified nucleic acid assay that detects Borrelia burgdorferi specific DNA sequences from Osp A plasmid and flagellin genomic genes, in clinical specimens. The gene fragments are first selected with specific probes. Then the DNA is amplified using specific primers. Lastly, the amplified products are detected by hybridization to specific probes in a dot-blot assay. The test also detects DNA to other Borrelia: B. afzeli, B. andersonii, B. garinii and B. mayonii.
Results
Genomic Positive: B. burgdorferi DNA detected.
Negative: B. burgdorferi DNA not detected.
Plasmid Positive: B. burgdorferi DNA detected.
Negative: B. burgdorferi DNA not detected.
Sample is considered positive if either genomic or plasmid is positive.
Limitation: The diagnostic value of a negative serum/urine/blood PCR result for Borrelia species is questionable because the number of organisms in serum/urine/blood is often low or nonexistent in patients with Lyme disease.
459 - Lyme Multiplex PCR CSF
The Lyme Multiplex PCR test is a 3 step amplified nucleic acid assay that detects Borrelia burgdorferi specific DNA sequences from Osp A plasmid and flagellin genomic genes, in clinical specimens. The gene fragments are first selected with specific probes. Then the DNA is amplified using specific primers. Lastly, the amplified products are detected by hybridization to specific probes in a dot-blot assay. The test also detects DNA to other Borrelia: B. afzeli, B. andersonii, B. garinii and B. mayonii.
Results
Genomic Positive: B. burgdorferi DNA detected.
Negative: B. burgdorferi DNA not detected.
Plasmid Positive: B. burgdorferi DNA detected.
Negative: B. burgdorferi DNA not detected.
Sample is considered positive if either genomic or plasmid is positive.
Limitation: The diagnostic value of a negative serum/urine/blood PCR result for Borrelia species is questionable because the number of organisms in serum/urine/blood is often low or nonexistent in patients with Lyme disease.
462 - Lyme Multiplex PCR Miscellaneous
The Lyme Multiplex PCR test is a 3 step amplified nucleic acid assay that detects Borrelia burgdorferi specific DNA sequences from Osp A plasmid and flagellin genomic genes, in clinical specimens. The gene fragments are first selected with specific probes. Then the DNA is amplified using specific primers. Lastly, the amplified products are detected by hybridization to specific probes in a dot-blot assay. The test also detects DNA to other Borrelia: B. afzeli, B. andersonii, B. garinii and B. mayonii.
Results
Genomic Positive: B. burgdorferi DNA detected.
Negative: B. burgdorferi DNA not detected.
Plasmid Positive: B. burgdorferi DNA detected.
Negative: B. burgdorferi DNA not detected.
Sample is considered positive if either genomic or plasmid is positive.
Limitation: The diagnostic value of a negative serum/urine/blood PCR result for Borrelia species is questionable because the number of organisms in serum/urine/blood is often low or nonexistent in patients with Lyme disease.
465 - Lyme Multiplex PCR Urine (Pooled)
The Lyme Multiplex PCR test is a 3 step amplified nucleic acid assay that detects Borrelia burgdorferi specific DNA sequences from Osp A plasmid and flagellin genomic genes, in clinical specimens. The gene fragments are first selected with specific probes. Then the DNA is amplified using specific primers. Lastly, the amplified products are detected by hybridization to specific probes in a dot-blot assay. The test also detects DNA to other Borrelia: B. afzeli, B. andersonii, B. garinii and B. mayonii.
Results
Genomic Positive: B. burgdorferi DNA detected.
Negative: B. burgdorferi DNA not detected.
Plasmid Positive: B. burgdorferi DNA detected.
Negative: B. burgdorferi DNA not detected.
Sample is considered positive if either genomic or plasmid is positive.
Limitation: The diagnostic value of a negative serum/urine/blood PCR result for Borrelia species is questionable because the number of organisms in serum/urine/blood is often low or nonexistent in patients with Lyme disease.
556 - TBRF PCR Whole Blood
The TBRF Borrelia and B. burgdorferi sensu lato real-time PCR test detects Relapsing Fever Borrelia DNA (including B. hermsii) and B. burgdorferi sensu lato DNA. It further speciates RF Borrelia to subgroup that includes B. turcatae, B. miyamotoi, B. parkeri, B. coriaceae, and B. recurrentis. DNA is extracted from clinical samples. The extracted DNA is amplified by real-time PCR with Borrelia specific DNA primers; RF Borrelia DNA (if present) is detected by RF Borrelia genus probe, speciated to RF Borrelia subgroup by RF Borrelia species probe; and B. burgdorferi sensu lato DNA (if present) is detected by the B. burgdorferi specific probe simultaneously. The primers and probes used for the selection of RF Borrelia and B. burgdorferi sensu lato DNA fragments are designed from published small subunit ribosomal RNA sequences of RF Borrelia group and B. burgdorferi sensu lato group. For diagnostic purposes PCR results should be used in conjunction with other data available to the physician.
Results for RF Borrelia Genus (detects RF Borrelia species including B. hermsii, B. turicatae, B. miyamotoi, B. parkeri, B. coriaceae, B. turcica, and B. recurrentis)
Positive: RF Borrelia DNA was detected
Negative: RF Borrelia DNA was not detected in the sample analyzed
Results for RF Borrelia Subgroup Species (detects RF Borrelia species including detects B. turicatae, B. miyamotoi, B. parkeri, B. coriaceae and B.recurrentis)
Positive: RF Borrelia species DNA was detected
Negative: RF Borrelia species DNA was not detected in the sample analyzed
Results for B. burgdorferi sensu lato (detects B. burgdorferi sensu stricto, B. afzelii, B. garinii, B. californiensis, B. mayonii, B. spielmanii and B. valaisiana)
Positive: B. burgdorferi sensu lato DNA was detected
Negative: B. burgdorferi sensu lato DNA was not detected in the sample analyzed
Results for Borrelia (detects B. chiliensis, B. sinica and B. japonica)
Positive: Borrelia DNA was detected
Negative: Borrelia DNA was not detected in the sample analyzed
Limitation: An inhibition study was performed on about 2000 clinical samples that included fresh whole blood, fresh serum, frozen urine and frozen CSF samples, according to NYS guidelines. It is clear that for all sample types tested, inhibition is well controlled and only occurred in less than 1% of samples. Therefore, no inhibition control is included in the assay.
Note: The diagnostic value of a negative serum/urine/blood PCR result for Borrelia species is questionable because the number of organisms in serum/urine/blood is often low or nonexistent in patients with Lyme disease.
559 - TBRF PCR Urine
The TBRF Borrelia and B. burgdorferi sensu lato real-time PCR test detects Relapsing Fever Borrelia DNA (including B. hermsii) and B. burgdorferi sensu lato DNA. It further speciates RF Borrelia to subgroup that includes B. turcatae, B. miyamotoi, B. parkeri, B. coriaceae, and B. recurrentis. DNA is extracted from clinical samples. The extracted DNA is amplified by real-time PCR with Borrelia specific DNA primers; RF Borrelia DNA (if present) is detected by RF Borrelia genus probe, speciated to RF Borrelia subgroup by RF Borrelia species probe; and B. burgdorferi sensu lato DNA (if present) is detected by the B. burgdorferi specific probe simultaneously. The primers and probes used for the selection of RF Borrelia and B. burgdorferi sensu lato DNA fragments are designed from published small subunit ribosomal RNA sequences of RF Borrelia group and B. burgdorferi sensu lato group. For diagnostic purposes PCR results should be used in conjunction with other data available to the physician.
Results for RF Borrelia Genus (detects RF Borrelia species including B. hermsii, B. turicatae, B. miyamotoi, B. parkeri, B. coriaceae, B. turcica, and B. recurrentis)
Positive: RF Borrelia DNA was detected
Negative: RF Borrelia DNA was not detected in the sample analyzed
Results for RF Borrelia Subgroup Species (detects RF Borrelia species including detects B. turicatae, B. miyamotoi, B. parkeri, B. coriaceae and B.recurrentis)
Positive: RF Borrelia species DNA was detected
Negative: RF Borrelia species DNA was not detected in the sample analyzed
Results for B. burgdorferi sensu lato (detects B. burgdorferi sensu stricto, B. afzelii, B. garinii, B. californiensis, B. mayonii, B. spielmanii and B. valaisiana)
Positive: B. burgdorferi sensu lato DNA was detected
Negative: B. burgdorferi sensu lato DNA was not detected in the sample analyzed
Results for Borrelia (detects B. chiliensis, B. sinica and B. japonica)
Positive: Borrelia DNA was detected
Negative: Borrelia DNA was not detected in the sample analyzed
Limitation: An inhibition study was performed on about 2000 clinical samples that included fresh whole blood, fresh serum, frozen urine and frozen CSF samples, according to NYS guidelines. It is clear that for all sample types tested, inhibition is well controlled and only occurred in less than 1% of samples. Therefore, no inhibition control is included in the assay.
Note: The diagnostic value of a negative serum/urine/blood PCR result for Borrelia species is questionable because the number of organisms in serum/urine/blood is often low or nonexistent in patients with Lyme disease.
562 - TBRF PCR Urine (Pooled)
The TBRF Borrelia and B. burgdorferi sensu lato real-time PCR test detects Relapsing Fever Borrelia DNA (including B. hermsii) and B. burgdorferi sensu lato DNA. It further speciates RF Borrelia to subgroup that includes B. turcatae, B. miyamotoi, B. parkeri, B. coriaceae, and B. recurrentis. DNA is extracted from clinical samples. The extracted DNA is amplified by real-time PCR with Borrelia specific DNA primers; RF Borrelia DNA (if present) is detected by RF Borrelia genus probe, speciated to RF Borrelia subgroup by RF Borrelia species probe; and B. burgdorferi sensu lato DNA (if present) is detected by the B. burgdorferi specific probe simultaneously. The primers and probes used for the selection of RF Borrelia and B. burgdorferi sensu lato DNA fragments are designed from published small subunit ribosomal RNA sequences of RF Borrelia group and B. burgdorferi sensu lato group. For diagnostic purposes PCR results should be used in conjunction with other data available to the physician.
Results for RF Borrelia Genus (detects RF Borrelia species including B. hermsii, B. turicatae, B. miyamotoi, B. parkeri, B. coriaceae, B. turcica, and B. recurrentis)
Positive: RF Borrelia DNA was detected
Negative: RF Borrelia DNA was not detected in the sample analyzed
Results for RF Borrelia Subgroup Species (detects RF Borrelia species including detects B. turicatae, B. miyamotoi, B. parkeri, B. coriaceae and B.recurrentis)
Positive: RF Borrelia species DNA was detected
Negative: RF Borrelia species DNA was not detected in the sample analyzed
Results for B. burgdorferi sensu lato (detects B. burgdorferi sensu stricto, B. afzelii, B. garinii, B. californiensis, B. mayonii, B. spielmanii and B. valaisiana)
Positive: B. burgdorferi sensu lato DNA was detected
Negative: B. burgdorferi sensu lato DNA was not detected in the sample analyzed
Results for Borrelia (detects B. chiliensis, B. sinica and B. japonica)
Positive: Borrelia DNA was detected
Negative: Borrelia DNA was not detected in the sample analyzed
Limitation: An inhibition study was performed on about 2000 clinical samples that included fresh whole blood, fresh serum, frozen urine and frozen CSF samples, according to NYS guidelines. It is clear that for all sample types tested, inhibition is well controlled and only occurred in less than 1% of samples. Therefore, no inhibition control is included in the assay.
Note: The diagnostic value of a negative serum/urine/blood PCR result for Borrelia species is questionable because the number of organisms in serum/urine/blood is often low or nonexistent in patients with Lyme disease.
565 - TBRF PCR CSF
The TBRF Borrelia and B. burgdorferi sensu lato real-time PCR test detects Relapsing Fever Borrelia DNA (including B. hermsii) and B. burgdorferi sensu lato DNA. It further speciates RF Borrelia to subgroup that includes B. turcatae, B. miyamotoi, B. parkeri, B. coriaceae, and B. recurrentis. DNA is extracted from clinical samples. The extracted DNA is amplified by real-time PCR with Borrelia specific DNA primers; RF Borrelia DNA (if present) is detected by RF Borrelia genus probe, speciated to RF Borrelia subgroup by RF Borrelia species probe; and B. burgdorferi sensu lato DNA (if present) is detected by the B. burgdorferi specific probe simultaneously. The primers and probes used for the selection of RF Borrelia and B. burgdorferi sensu lato DNA fragments are designed from published small subunit ribosomal RNA sequences of RF Borrelia group and B. burgdorferi sensu lato group. For diagnostic purposes PCR results should be used in conjunction with other data available to the physician.
Results for RF Borrelia Genus (detects RF Borrelia species including B. hermsii, B. turicatae, B. miyamotoi, B. parkeri, B. coriaceae, B. turcica, and B. recurrentis)
Positive: RF Borrelia DNA was detected
Negative: RF Borrelia DNA was not detected in the sample analyzed
Results for RF Borrelia Subgroup Species (detects RF Borrelia species including detects B. turicatae, B. miyamotoi, B. parkeri, B. coriaceae and B.recurrentis)
Positive: RF Borrelia species DNA was detected
Negative: RF Borrelia species DNA was not detected in the sample analyzed
Results for B. burgdorferi sensu lato (detects B. burgdorferi sensu stricto, B. afzelii, B. garinii, B. californiensis, B. mayonii, B. spielmanii and B. valaisiana)
Positive: B. burgdorferi sensu lato DNA was detected
Negative: B. burgdorferi sensu lato DNA was not detected in the sample analyzed
Results for Borrelia (detects B. chiliensis, B. sinica and B. japonica)
Positive: Borrelia DNA was detected
Negative: Borrelia DNA was not detected in the sample analyzed
Limitation: An inhibition study was performed on about 2000 clinical samples that included fresh whole blood, fresh serum, frozen urine and frozen CSF samples, according to NYS guidelines. It is clear that for all sample types tested, inhibition is well controlled and only occurred in less than 1% of samples. Therefore, no inhibition control is included in the assay.
Note: The diagnostic value of a negative serum/urine/blood PCR result for Borrelia species is questionable because the number of organisms in serum/urine/blood is often low or nonexistent in patients with Lyme disease.
568 - TBRF PCR Miscellaneous
The TBRF Borrelia and B. burgdorferi sensu lato real-time PCR test detects Relapsing Fever Borrelia DNA (including B. hermsii) and B. burgdorferi sensu lato DNA. It further speciates RF Borrelia to subgroup that includes B. turcatae, B. miyamotoi, B. parkeri, B. coriaceae, and B. recurrentis. DNA is extracted from clinical samples. The extracted DNA is amplified by real-time PCR with Borrelia specific DNA primers; RF Borrelia DNA (if present) is detected by RF Borrelia genus probe, speciated to RF Borrelia subgroup by RF Borrelia species probe; and B. burgdorferi sensu lato DNA (if present) is detected by the B. burgdorferi specific probe simultaneously. The primers and probes used for the selection of RF Borrelia and B. burgdorferi sensu lato DNA fragments are designed from published small subunit ribosomal RNA sequences of RF Borrelia group and B. burgdorferi sensu lato group. For diagnostic purposes PCR results should be used in conjunction with other data available to the physician.
Results for RF Borrelia Genus (detects RF Borrelia species including B. hermsii, B. turicatae, B. miyamotoi, B. parkeri, B. coriaceae, B. turcica, and B. recurrentis)
Positive: RF Borrelia DNA was detected
Negative: RF Borrelia DNA was not detected in the sample analyzed
Results for RF Borrelia Subgroup Species (detects RF Borrelia species including detects B. turicatae, B. miyamotoi, B. parkeri, B. coriaceae and B.recurrentis)
Positive: RF Borrelia species DNA was detected
Negative: RF Borrelia species DNA was not detected in the sample analyzed
Results for B. burgdorferi sensu lato (detects B. burgdorferi sensu stricto, B. afzelii, B. garinii, B. californiensis, B. mayonii, B. spielmanii and B. valaisiana)
Positive: B. burgdorferi sensu lato DNA was detected
Negative: B. burgdorferi sensu lato DNA was not detected in the sample analyzed
Results for Borrelia (detects B. chiliensis, B. sinica and B. japonica)
Positive: Borrelia DNA was detected
Negative: Borrelia DNA was not detected in the sample analyzed
Limitation: An inhibition study was performed on about 2000 clinical samples that included fresh whole blood, fresh serum, frozen urine and frozen CSF samples, according to NYS guidelines. It is clear that for all sample types tested, inhibition is well controlled and only occurred in less than 1% of samples. Therefore, no inhibition control is included in the assay.
Note: The diagnostic value of a negative serum/urine/blood PCR result for Borrelia species is questionable because the number of organisms in serum/urine/blood is often low or nonexistent in patients with Lyme disease.
573 - TBRF PCR Serum
The TBRF Borrelia and B. burgdorferi sensu lato real-time PCR test detects Relapsing Fever Borrelia DNA (including B. hermsii) and B. burgdorferi sensu lato DNA. It further speciates RF Borrelia to subgroup that includes B. turcatae, B. miyamotoi, B. parkeri, B. coriaceae, and B. recurrentis. DNA is extracted from clinical samples. The extracted DNA is amplified by real-time PCR with Borrelia specific DNA primers; RF Borrelia DNA (if present) is detected by RF Borrelia genus probe, speciated to RF Borrelia subgroup by RF Borrelia species probe; and B. burgdorferi sensu lato DNA (if present) is detected by the B. burgdorferi specific probe simultaneously. The primers and probes used for the selection of RF Borrelia and B. burgdorferi sensu lato DNA fragments are designed from published small subunit ribosomal RNA sequences of RF Borrelia group and B. burgdorferi sensu lato group. For diagnostic purposes PCR results should be used in conjunction with other data available to the physician.
Results for RF Borrelia Genus (detects RF Borrelia species including B. hermsii, B. turicatae, B. miyamotoi, B. parkeri, B. coriaceae, B. turcica, and B. recurrentis)
Positive: RF Borrelia DNA was detected
Negative: RF Borrelia DNA was not detected in the sample analyzed
Results for RF Borrelia Subgroup Species (detects RF Borrelia species including detects B. turicatae, B. miyamotoi, B. parkeri, B. coriaceae and B.recurrentis)
Positive: RF Borrelia species DNA was detected
Negative: RF Borrelia species DNA was not detected in the sample analyzed
Results for B. burgdorferi sensu lato (detects B. burgdorferi sensu stricto, B. afzelii, B. garinii, B. californiensis, B. mayonii, B. spielmanii and B. valaisiana)
Positive: B. burgdorferi sensu lato DNA was detected
Negative: B. burgdorferi sensu lato DNA was not detected in the sample analyzed
Results for Borrelia (detects B. chiliensis, B. sinica and B. japonica)
Positive: Borrelia DNA was detected
Negative: Borrelia DNA was not detected in the sample analyzed
Limitation: An inhibition study was performed on about 2000 clinical samples that included fresh whole blood, fresh serum, frozen urine and frozen CSF samples, according to NYS guidelines. It is clear that for all sample types tested, inhibition is well controlled and only occurred in less than 1% of samples. Therefore, no inhibition control is included in the assay.
Note: The diagnostic value of a negative serum/urine/blood PCR result for Borrelia species is questionable because the number of organisms in serum/urine/blood is often low or nonexistent in patients with Lyme disease.
601 - Broad Coverage Lyme Ab Assay
The Lyme Broad Coverage Antibody (BCA) Assay is a qualitative test designed to detect IgM and IgG antibodies to Lyme Borreliae group-specific antigens in human serum. The sensitivity of the Lyme BCA Assay is 90%, and the specificity is 97%.
Results
Positive: Lyme Borreliae antigens detected
Negative: Lyme Borreliae antigens not detected
Limitation: For specific protein or band information, an ImmunoBlot IgM or IgG test should be ordered to provide more information and possible speciation of the Borrelia. A negative Lyme ImmunoBlot IgG does not exclude the possibility of infection with B. burgdorferi. IGeneX interpretation is based on internal validation studies. The results of this test must be interpreted in relation to patient’s clinical history, epidemiological data, stage of disease, clinical symptoms or other laboratory results.
602 - Broad Coverage TBRF Ab Assay
The TBRF Broad Coverage Antibody Assay (BCA) is a qualitative test designed to detect IgM and IgG antibodies to TBRF Borreliae group-specific antigens in human serum. A positive test suggests exposure to the TBRF Borreliae group, and should be used in conjunction with patient clinical symptoms and history. The BCA Assay is a simple and cost-effective test, which gives either a positive or negative result.
Results
Positive: TBRF Borreliae group-specific antigens detected.
Negative: TBRF Borreliae group-specific antigens not detected
Limitation: A positive result suggests exposure to TBRF Borrelia. For diagnostic purposes, immunoblot test results should be used in conjunction with clinical symptoms and other evidence available to the diagnosing physician. If the test result is indeterminate, testing with another method or retesting in 6-8 weeks is recommended.
640 - Babesia FISH
The Babesia Fluorescent In-Situ Hybridization (FISH) assay is a qualitative test that detects ribosomal RNA of Babesia directly in a blood smear. The Babesia FISH test provides a significant increase in sensitivity and specificity over standard Geimsa-stained smears for the presence of intraerythrocytic parasites (piroplasts) in RBCs. The parasites exist as ring and/or merozoite forms.
Results
Positive: Must show fluorescing rings inside at least two RBCs
Negative: Must show no fluorescence within RBCs
Limitation: A single negative FISH test result does not exclude the possibility of Babesia infection. Results should be interpreted in conjunction with other laboratory and clinical findings.
663 - Babesia PCR Whole Blood
The Babesia microti/duncani Polymerase Chain Reaction (PCR) screen test detects Babesia-specific (B. microti and/or B. duncani) DNA in human specimen. Babesia ribosomal DNA (rDNA) fragments are hybrid-selected by probes, followed by PCR amplification of selected Babesia rDNA. PCR products are detected Babesia-specific probes in a dot-blot assay. The primers and probes used for the selection of Babesia rDNA fragments are designed from published small subunit ribosomal RNA sequences (NCBI: GI 1453221 for B. microti and GI 6272590 for B. duncani).
Results
Positive Babesia specific DNA detected
Negative Babesia specific DNA not detected
665 - Babesia PCR Urine
The Babesia microti/duncani Polymerase Chain Reaction (PCR) screen test detects Babesia-specific (B. microti and/or B. duncani) DNA in human specimen. Babesia ribosomal DNA (rDNA) fragments are hybrid-selected by probes, followed by PCR amplification of selected Babesia rDNA. PCR products are detected Babesia-specific probes in a dot-blot assay. The primers and probes used for the selection of Babesia rDNA fragments are designed from published small subunit ribosomal RNA sequences (NCBI: GI 1453221 for B. microti and GI 6272590 for B. duncani).
Results
Positive Babesia specific DNA detected
Negative Babesia specific DNA not detected
720 - B. duncani IgM & IgG IFA
The Babesia duncani Indirect Immunofluorescent Antibody (IFA) test detects IgM and IgG antibodies to B. duncani in human serum.
Results (titers)
IgM < 20: Negative. 20 may or may not indicate active infection.
IgM 40: Indicates active infection
IgG < 40: Negative
IgG 40 to < 160: May or may not suggest active infection. In patients with previously high titers, such titers may indicate resolving infection.
IgG 160: Indicates active infection
Limitation: Presence of both IgM and IgG together also indicates active infection. There is a low level of cross-reaction between B. duncani and B. microti IFA tests. In geographic regions where both species are present, we recommend that patient sera be tested by both B. duncani and B. microti IFA tests. A single negative IFA test does not rule out infection. Paired testing of acute and convalescent sera collected six-to-eight weeks apart is recommended for accurate diagnosis.
750 - HME (Ehrlichia chaffeensis) PCR Serum
The HME (Human Monocytic Ehrlichiosis) PCR test detects Erhlichia chaffeensis rDNA fragments in the patient samples. The E. chaffeensis rDNA fragments are hybrid selected by probes, followed by PCR amplification of the selected fragments using Ehrlichia specific primers. E. chaffeensis specific PCR products are then detected with probes in a dot-blot assay.
Results
Positive: E. chaffeensis rDNA detected.
Negative: E. chaffeensis rDNA not detected.
755 - HGA (Anaplasma phagocytophilum) PCR Serum
The HGA (Human Granulocytic Anaplasmosis) PCR test detects Anaplasma phagocytophilum rDNA fragments in the patient specimens. The A. phagocytophilum rDNA fragments are hybrid-selected by probes, followed by PCR amplification of the selected fragments using Anaplasma specific primers. A. phagocytophilum specific PCR products are then detected with probes in a dot-blot assay.
Results
Positive: A. phagocytophilum rDNA detected
Negative: A. phyagocytophilum rDNA not detected
770 - HME (Ehrlichia chaffeensis) PCR Whole Blood
The HME (Human Monocytic Ehrlichiosis) PCR test detects Erhlichia chaffeensis rDNA fragments in the patient samples. The E. chaffeensis rDNA fragments are hybrid selected by probes, followed by PCR amplification of the selected fragments using Ehrlichia specific primers. E. chaffeensis specific PCR products are then detected with probes in a dot-blot assay.
Results
Positive: E. chaffeensis rDNA detected.
Negative: E. chaffeensis rDNA not detected.
775 - HGA (Anaplasma phagocytophilum) PCR Whole Blood
The HGA (Human Granulocytic Anaplasmosis) PCR test detects Anaplasma phagocytophilum rDNA fragments in the patient specimens. The A. phagocytophilum rDNA fragments are hybrid-selected by probes, followed by PCR amplification of the selected fragments using Anaplasma specific primers. A. phagocytophilum specific PCR products are then detected with probes in a dot-blot assay.
Results
Positive: A. phagocytophilum rDNA detected
Negative: A. phyagocytophilum rDNA not detected
780 - HME (Ehrlichia chaffeensis) PCR Urine
The HME (Human Monocytic Ehrlichiosis) PCR test detects Erhlichia chaffeensis rDNA fragments in the patient samples. The E. chaffeensis rDNA fragments are hybrid selected by probes, followed by PCR amplification of the selected fragments using Ehrlichia specific primers. E. chaffeensis specific PCR products are then detected with probes in a dot-blot assay.
Results
Positive: E. chaffeensis rDNA detected.
Negative: E. chaffeensis rDNA not detected.
785 - HGA (Anaplasma phagocytophilum) PCR Urine
The HGA (Human Granulocytic Anaplasmosis) PCR test detects Anaplasma phagocytophilum rDNA fragments in the patient specimens. The A. phagocytophilum rDNA fragments are hybrid-selected by probes, followed by PCR amplification of the selected fragments using Anaplasma specific primers. A. phagocytophilum specific PCR products are then detected with probes in a dot-blot assay.
Results
Positive: A. phagocytophilum rDNA detected
Negative: A. phyagocytophilum rDNA not detected
800 - Lyme Dot Blot (1 sample)
The Lyme Dot-blot Assay (LDA) is a qualitative immunoassay for the direct detection of B. burgdorferi specific antigens in urine that react specifically to the following B. burgdorferi antibodies: 23-25kDa (OspC), 31kDa, 39kDa and 93kDa.
Results
Positive: B. burgdorferi antigens detected
Negative: B. burgdorferi antigens not detected
Limitation: Cross-reactions can occur with other microorganisms present in urine samples. Therefore, clinicians should use caution in the interpretation of a positive result when no other Lyme diagnostic test result is positive.
802 - Lyme Dot Blot (2 samples)
The Lyme Dot-blot Assay (LDA) is a qualitative immunoassay for the direct detection of B. burgdorferi specific antigens in urine that react specifically to the following B. burgdorferi antibodies: 23-25kDa (OspC), 31kDa, 39kDa and 93kDa.
Results
Positive: B. burgdorferi antigens detected
Negative: B. burgdorferi antigens not detected
Limitation: Cross-reactions can occur with other microorganisms present in urine samples. Therefore, clinicians should use caution in the interpretation of a positive result when no other Lyme diagnostic test result is positive.
805 - Lyme Dot Blot (3 samples)
The Lyme Dot-blot Assay (LDA) is a qualitative immunoassay for the direct detection of B. burgdorferi specific antigens in urine that react specifically to the following B. burgdorferi antibodies: 23-25kDa (OspC), 31kDa, 39kDa and 93kDa.
Results
Positive: B. burgdorferi antigens detected
Negative: B. burgdorferi antigens not detected
Limitation: Cross-reactions can occur with other microorganisms present in urine samples. Therefore, clinicians should use caution in the interpretation of a positive result when no other Lyme diagnostic test result is positive.
810 - Lyme Dot Blot – CSF
The Lyme Dot-blot Assay (LDA) is a qualitative immunoassay for the direct detection of B. burgdorferi specific antigens in CSF that react specifically to the following B. burgdorferi antibodies: 23-25kDa (OspC), 31kDa, 39kDa and 93kDa.
Results
Positive: B. burgdorferi antigens detected
Negative: B. burgdorferi antigens not detected
Limitation: Cross-reactions can occur with other microorganisms present in CSF samples. Therefore, clinicians should use caution in the interpretation of a positive result when no other Lyme diagnostic test result is positive.
965 - R. rickettsii & R. typhi IgG IFA
The Rickettsia indirect immunofluorescent antibody test detects IgG antibodies to Rickettsia species in human serum. The species include Rickettsia rickettsii, causative agent of Rocky Mountain Spotted Fever and Ri. typhi, causative agent of Murine typhus respectively.
Results for Spotted Fever Group or Typhus Fever Group (titers)
IgG < 40: Negative
40 to < 160: May or may not suggest active infection. In patients with previously high titers, such titers may indicate resolving infection.
160: Suggests active infection
Limitation: Cross-reactions can occur among the Rickettsiaceae, including Rickettsia, Ehrlichia and Anaplasma. A single negative IFA test does not rule out infection. Paired testing of acute and convalescent sera collected six to eight weeks apart is recommended for accurate diagnosis.
970 - Rickettsia PCR Urine
The Rickettsia PCR test detects Rickettsia species specific DNA in clinical samples. Rickettsia 17kDa antigen gene fragments are hybrid selected by probes, followed by PCR amplification of the selected DNA fragment. PCR products are detected with Rickettsia specific probes: Rickettsia rickettsii and Rickettsia felis/typhi in dot blot assays. The primers and probes used for the selection of Rickettsia gene fragment encoding the 17kDa antigen DNA fragments are designed from published sequences (NCBI: GI:30844225) (Anderson et al 1988 J Bacteriol 170:4493-4500); Tzianabos et al J Clin Microbiol 1989:2866-2868).
Results
Positive: Rickettsia specific DNA detected.
Negative: Rickettsia specific DNA not detected.
986 - Rickettsia PCR – CSF
The Rickettsia PCR test detects Rickettsia species specific DNA in clinical samples. Rickettsia 17kDa antigen gene fragments are hybrid selected by probes, followed by PCR amplification of the selected DNA fragment. PCR products are detected with Rickettsia specific probes: Rickettsia rickettsii and Rickettsia felis/typhi in dot blot assays. The primers and probes used for the selection of Rickettsia gene fragment encoding the 17kDa antigen DNA fragments are designed from published sequences (NCBI: GI:30844225) (Anderson et al 1988 J Bacteriol 170:4493-4500); Tzianabos et al J Clin Microbiol 1989:2866-2868).
Results
Positive: Rickettsia specific DNA detected.
Negative: Rickettsia specific DNA not detected.
998 - Rickettsia PCR Whole Blood
The Rickettsia PCR test detects Rickettsia species specific DNA in clinical samples. Rickettsia 17kDa antigen gene fragments are hybrid selected by probes, followed by PCR amplification of the selected DNA fragment. PCR products are detected with Rickettsia specific probes: Rickettsia rickettsii and Rickettsia felis/typhi in dot blot assays. The primers and probes used for the selection of Rickettsia gene fragment encoding the 17kDa antigen DNA fragments are designed from published sequences (NCBI: GI:30844225) (Anderson et al 1988 J Bacteriol 170:4493-4500); Tzianabos et al J Clin Microbiol 1989:2866-2868).
Results
Positive: Rickettsia specific DNA detected.
Negative: Rickettsia specific DNA not detected.
