NEW MICROBIOLOGY TEST: CRYPTOCOCCAL ANTIGEN BY LFA

Effective May 13th, 2019, the Microbiology Laboratory will be changing the methodology of Cryptococcal antigen testing from the Meridien Enzyme Immunoassay (EIA) to the more sensitive IMMY CrAg Lateral Flow Assay (LFA). The specimen requirement is a minimum 0.2 ml serum and/or CSF. This change will also affect how titers are reported. Please see below with changes marked in blue.

Parameter Old Method New Method
Sensitivity Serotype A: 28 ng CrAg/mLB: 23 ng CrAg/mLC: >2,000 ng CrAg/mLD: 770 ng CrAg/mL Serotype A: 1 ng CrAg/mLB: 1 ng CrAg/mLC: 9 ng CrAg/mLD: 8 ng CrAg/mL
Titer Range 1:2 – 1:18,750 1:5 – 1:2,560Titers >1:2,560 can be determined upon request

This test will be run from 6am-9:30pm with a turnaround time of ~1 hour. Specimens arriving after the cut-off time will be run immediately the following morning. Results will be reported in PowerChart under Special Microbiology, and positive results will be called to the provider. Please call the Laboratory (x5750) or the Microbiology Manager, Dr. Holly Huse (x5780), if you have any questions or concerns.
 

NEW MICROBIOLOGY TEST: BIOFIRE FILMARRAY MENINGITIS/ENCEPHALITIS (ME) PANEL

Effective May 13th, 2019, the Microbiology Laboratory will begin in-house testing of the BioFire FilmArray Meningitis/Encephalitis (ME) Panel. This rapid PCR based test has been previously sent to ARUP. The specimen requirement is a minimum of 0.25 ml CSF. This test does NOT replace CSF culture and/or Cryptococcal antigen testing. The test can be ordered as a Careset “ME Panel by PCR with Bacterial Culture.” When appropriate, fungal culture and Cryptococcal antigen testing should be ordered in addition to the FilmArray ME Panel and bacterial culture.

Targets on the test:

Bacteria:

  • Escherichia coli K1
  • Haemophilus influenzae
  • Listeria monocytogenes
  • Neisseria meningitidis (encapsulated)
  • Streptococcus agalactiae
  • Streptococcus pneumoniae

Viruses:

  • Cytomegalovirus
  • Enterovirus
  • Herpes simplex virus 1
  • Herpes simplex virus 2
  • Human herpesvirus 6
  • Human parechovirus
  • Varicella zoster virus

Yeast:

Cryptococcus neoformans/gattii

The overall sensitivity and specificity of this test is 94.2% and 99.8%, respectively.

Test limitations include:

  • The FilmArray ME Panel is NOT a replacement for CSF bacterial and/or fungal culture and Cryptococcal antigen testing for at-risk patients.
  • Non-K1 E. coli serotypes and non-encapsulated strains of Neisseria meningitidis are NOT detected.
  • The panel does NOT differentiate active from latent HSV, CMV, or HHV-6 infections.
  • A negative result should not rule-out central nervous system infection in patients with a high pretest probability for meningitis or encephalitis. False negatives can occur when the concentration of nucleic acids in the specimen is below the limit of detection of the test.
  • False positives can occur due to the sensitive nature of the FilmArray ME Panel. Results are intended to aid in the diagnosis of illness and are meant to be used in conjunction with other clinical and epidemiological findings.

The test will be run daily from 6am-4:30pm. Specimens that reach the lab after the cut-off time will be run STAT the following morning. All positive results will be called to the provider. Reports will appear in PowerChart. Please make sure to review the attached comment that describes the test limitations.

Please call the Laboratory (x5750) or the Microbiology Manager, Dr. Holly Huse (x5780), if you have any questions or concerns.



NEW MICROBIOLOGY TEST: CRYPTOCOCCAL ANTIGEN BY LFA

Effective May 13th, 2019, the Microbiology Laboratory will be changing the methodology of Cryptococcal antigen testing from the Meridien Enzyme Immunoassay (EIA) to the more sensitive IMMY CrAg Lateral Flow Assay (LFA). The specimen requirement is a minimum 0.2 ml serum and/or CSF. This change will also affect how titers are reported. Please see below with changes marked in blue.

Parameter Old Method New Method
Sensitivity Serotype A: 28 ng CrAg/mLB: 23 ng CrAg/mLC: >2,000 ng CrAg/mLD: 770 ng CrAg/mL Serotype A: 1 ng CrAg/mLB: 1 ng CrAg/mLC: 9 ng CrAg/mLD: 8 ng CrAg/mL
Titer Range 1:2 – 1:18,750 1:5 – 1:2,560Titers >1:2,560 can be determined upon request

This test will be run from 6am-9:30pm with a turnaround time of ~1 hour. Specimens arriving after the cut-off time will be run immediately the following morning. Results will be reported in PowerChart under Special Microbiology, and positive results will be called to the provider. Please call the Laboratory (x5750) or the Microbiology Manager, Dr. Holly Huse (x5780), if you have any questions or concerns.
 

NEW MICROBIOLOGY TEST: BIOFIRE FILMARRAY MENINGITIS/ENCEPHALITIS (ME) PANEL

Effective May 13th, 2019, the Microbiology Laboratory will begin in-house testing of the BioFire FilmArray Meningitis/Encephalitis (ME) Panel. This rapid PCR based test has been previously sent to ARUP. The specimen requirement is a minimum of 0.25 ml CSF. This test does NOT replace CSF culture and/or Cryptococcal antigen testing. The test can be ordered as a Careset “ME Panel by PCR with Bacterial Culture.” When appropriate, fungal culture and Cryptococcal antigen testing should be ordered in addition to the FilmArray ME Panel and bacterial culture.

Targets on the test:

Bacteria:

  • Escherichia coli K1
  • Haemophilus influenzae
  • Listeria monocytogenes
  • Neisseria meningitidis (encapsulated)
  • Streptococcus agalactiae
  • Streptococcus pneumoniae

Viruses:

  • Cytomegalovirus
  • Enterovirus
  • Herpes simplex virus 1
  • Herpes simplex virus 2
  • Human herpesvirus 6
  • Human parechovirus
  • Varicella zoster virus

Yeast:

Cryptococcus neoformans/gattii

The overall sensitivity and specificity of this test is 94.2% and 99.8%, respectively.

Test limitations include:

  • The FilmArray ME Panel is NOT a replacement for CSF bacterial and/or fungal culture and Cryptococcal antigen testing for at-risk patients.
  • Non-K1 E. coli serotypes and non-encapsulated strains of Neisseria meningitidis are NOT detected.
  • The panel does NOT differentiate active from latent HSV, CMV, or HHV-6 infections.
  • A negative result should not rule-out central nervous system infection in patients with a high pretest probability for meningitis or encephalitis. False negatives can occur when the concentration of nucleic acids in the specimen is below the limit of detection of the test.
  • False positives can occur due to the sensitive nature of the FilmArray ME Panel. Results are intended to aid in the diagnosis of illness and are meant to be used in conjunction with other clinical and epidemiological findings.

The test will be run daily from 6am-4:30pm. Specimens that reach the lab after the cut-off time will be run STAT the following morning. All positive results will be called to the provider. Reports will appear in PowerChart. Please make sure to review the attached comment that describes the test limitations.

Please call the Laboratory (x5750) or the Microbiology Manager, Dr. Holly Huse (x5780), if you have any questions or concerns.