| Test | In Range | Out Of Range | Units | Reference |
|---|---|---|---|---|
| ------------------------------------------------ | ||||
| B. duncani IFA (G/M) | ||||
| ------------------------------------------------ | ||||
| REVISED: 1/11/11 | ||||
| The Babesia duncani immunoflurescent antibody test is used to detect antibodies to B. duncani in human serum. | ||||
| Interpretation (Titer): | ||||
| IgM < 20 Negative, IgG < 40 Negative | ||||
| IgM 20 or IgG 40 to 160 may or may not indicate active infection. In patients with previously high titers, such titers indicate resolving infection. | ||||
| IgM or IgG > 160 suggests active infection with B. duncani. Titers rise during the first 2 - 4 weeks of illness and decline over 6 to 12 months. | ||||
| 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. If the IFA is negative but the clinical symptoms of babesiosis are present, PCR and/or FISH testing is suggested. Since Babesia is carried by the same ticks that cause ehrlichiosis and Lyme disease, patients with positive titers to Babesia should also be tested for other tick-borne diseases. Note:: antibodies to other Babesia species can cross-react and produce a positive result in B. duncani IFA test. | ||||
| This test was 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. | ||||
| B. duncani | ||||
| IgM | Negative | < 20 | ||
| IgG | Negative | < 40 | ||
| Diagnosis should not be based on laboratory tests alone. Results should be interpreted in conjunction with clinical symptoms and patient history. | ||||
| ------------------------------------------------ | ||||
| Babesia Fish (RNA) | Negative | |||
| REVISED 4/13/09 | ||||
| The Fluorescent in situ Hybridization Test (FISH) 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.
A positive sample must show fluorescing rings within 3 RBCs. A negative sample must show no fluorescence within the RBCs, This test was developed and its performance determined by IGeneX, Inc. The FDA has determined that such approval is not necessary. The test is used for clinical proposes and should not be regarded as investigational or for research. This laboratory is licensed by CMS and NYS to perform high complexity clinical testing. |
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| Diagnosis should not be based on laboratory tests alone. Results should be interpreted in conjunction with clinical symptoms and patient history. | ||||
| ------------------------------------------------ | ||||
| HME Panel (monocytic) | ||||
| ------------------------------------------------ | ||||
| REVISED: 12/21/10 | ||||
| The human monocytic ehrlichiosis (HME) IFA (IgG, IgM) is an immunofluorescent antibody test which detects antibodies to Ehrlichia chaffeensis, the agent of HME in human serum. | ||||
| Interpretation (Titer): | ||||
| (Titer is the reciprocal of a dilution at which a sample is positive at end-point. Example: end-point dilution is 1:160, the titer is 160.) | ||||
| IgM < 20 Negative, IgG < 40 Negative | ||||
| IgM 20 or IgG 40 to 160 may or may not indicate active infection. In patients with previously high titers, such titers indicate resolving infection. | ||||
| IgM or IgG > 160 suggests active infection with B. duncani. Titers rise during the first 2 - 4 weeks of illness and decline over 6 to 12 months. | ||||
| Note: Cross-reactions can occur among the Rickettsiaceae, including Rickettsia, Ehrlichia and Anaplasma. A single negative IFA test does not rule out infection. Samples that are IgM reactive but below the cutoff on IgG may be false positives or representative of cross reactive antibodies. Collection of another sample at least 3 weeks later, and repeat testing with paired acute and convalescent sera is recommended. If the IFA is ;negative but the clinical symptoms of HME are present, PCR testing is suggested. Since Ehrlichia is carried by the same ticks that cause babesiosis and Lyme Disease, patients with positive titers should also be tested for other tick-borne diseases.
This test was developed and its performance determined by IGeneX, Inc. 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. This laboratory is licensed by CMS and NYS to perform high complexity clinical testing. |
||||
| E. chaffeensis | ||||
| IgM | Negative | < 20 | ||
| IgG | Negative | < 40 | ||
| Diagnosis should not be based on laboratory tests alone. Results should be interpreted in conjunction with clinical symptoms and patient history. | ||||
| ------------------------------------------------ | ||||
| HGE Panel (granulocytic) | ||||
| ------------------------------------------------ | ||||
| REVISED: 12/21/10 | ||||
| The A. phagocytophilum IFA (IgG, IgM) is an immunoflurescent antibody test which detects antibodies to Anaplasma phagocytophilum, the agent of the human granulocytic ehrlichiosis (HGE) in human serum. | ||||
| Interpretation (Titer): | ||||
| (Titer is the reciprocal of a dilution at which a sample is positive at end-point. Example: end-point dilution is 1:160, the titer is 160.) | ||||
| IgM < 20 Negative, IgG < 40 Negative | ||||
| IgM 20 or IgG 40 to 160 may or may not indicate active infection. In patients with previously high titers, such titers indicate resolving infection. | ||||
| IgM or IgG > 160 suggests active infection with B. duncani. Titers rise during the first 2 - 4 weeks of illness and decline over 6 to 12 months. | ||||
| Note: Cross-reactions can occur among the Rickettsiaceae, including Rickettsia, Ehrlichia and Anaplasma. A single negative IFA test does not rule out infection. Samples that are IgM reactive but below the cutoff on IgG may be false positives or representative of cross reactive antibodies. Collection of another sample at least 3 weeks later, and repeat testing with paired acute and convalescent sera is recommended. If the IFA is negative but the clinical symptoms of HME are present, PCR testing is suggested. Since Ehrlichia is carried by the same ticks that cause babesiosis and Lyme Disease, patients with positive titers should also be tested for other tick-borne diseases. | ||||
| This test was developed and its performance determined by IGeneX, Inc. 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. This laboratory is licensed by CMS and NYS to perform high complexity clinical testing. | ||||
| A. phagocytophilum | ||||
| IgM | Negative | < 20 | ||
| IgG | Negative | < 40 | ||
| Diagnosis should not be based on laboratory tests alone. Results should be interpreted in conjunction with clinical symptoms and patient history. | ||||
| ------------------------------------------------ | ||||
| B. henselae IFA (G/M) | ||||
| ------------------------------------------------ | ||||
| REVISED: 1/11/11 | ||||
| The Bartonella henselae immunofluorescent antibody test is used to detect antibodies to B. henselae in human serum. | ||||
| Interpretation (Titer): | ||||
| IgM < 20 Negative, IgG < 40 Negative | ||||
| IgM 20 or IgG 40 to 160 may or may not indicate active infection. In patients with previously high titers, such titers indicate resolving infection. | ||||
| IgM or IgG > 160 suggests active infection with B. duncani. Titers rise during the first 2 - 4 weeks of illness and decline over 6 to 12 months. | ||||
| Note: 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. If the IFA is negative but the clinical symptoms are present PCR testing is suggested. Since Bartonella is carried by the same ticks that cause ehrlichiosis and Lyme disease, patients with positive titers should also be tested for other tick-borne diseases. | ||||
| This test was 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 a s investigational or for research. IGeneX, Inc. is licensed by CMS and NYS to perform high complexity clinical laboratory testing. | ||||
| B. henselae IFA | ||||
| IgM | Negative | < 20 | ||
| IgG | Negative | < 40 | ||
| Diagnosis should not be based on laboratory tests alone. Results should be interpreted in conjunction with clinical symptoms and patient history. | ||||
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