Fill - Free fillable TABLE OF CONTENTS TEST PAGE Bordetella species culture (Vermont Department of Information and Innovation on behalf of Vermont Dept of Health) PDF form

Clinical Lab Services Manual

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TABLE OF CONTENTS

TEST PAGE

Bordetella species culture 3

Bordetella species PCR – B. pertussis, B. parapertussis, B holmseii 3

Brucella Total Antibody 4

Campylobacter jejuni 4

Cellestis Quantiferon®-TB Gold In-Tube Test (M. tuberculosis) 13

Chlamydia trachomatis Amplified Test 5

Cryptosporidim parvuum EIA 5

Cyclospora sp. 6

E. coli O157:H7 6

E. coli Shiga-like Toxin 7

Enteric Screen 7

Giardia intestinalis (syn. lamblia) EIA 8

Gonorrhea Culture 8

Haemophilis influenzae 8

Hepatitis B Panel 9

Hepatitis B Core Total Antibody 9

Hepatitis B Core IgM Antibody 9

Hepatitis B Surface Antibody 10

Hepatitis B Surface Antibody Quantitation 10

Hepatitis B Surface Antigen 10

Hepatitis C Antibody (Screen) 11

HIV-1 Oral Fluid 11

HIV-1 Oral Fluid Western Blot 11

HIV-1/HIV-2 (Screen) 12

HIV-1/HIV-2 Antibody Differentiation Innumoassay 12

Influenza PCR 14

Interferon-Gamma Release Assay (M. tuberculosis) 13

Lead, Adult Blood (Diagnostic) 15

Lead, Childhood Blood (Diagnostic) 15

Legionella Culture 15

Legionella IgG Antibody 16

Legionella Urine Antigen 16

Listeria spp. 16

Measles (Rubeola) IgG Antibody (Diagnostic) 17

Measles (Rubeola) IgG Antibody (Immune status) 17

Measles (Rubeola) IgM Antibody (Diagnostic) 17

Measles (Rubeola) Real Time Reverse Transcriptase PCR (rRT-PCR) 18

and Viral Isolation

Mumps IgG Antibody (Immune status) 18

Mumps Real Time Reverse Transcriptase PCR (rRT-PCR) 18

Mycology 19

Mycobacteria 20

Mycobacterium tuberculosis Amplified Direct Test 21

M. tuberculosis Antimicrobial Susceptibility AFB Primary Drug Panel 21

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M. tuberculosis Cellestis Quantiferon®-TB Gold In-Tube Test 13

Neisseria gonorrhoeae Amplified Test 22

TABLE OF CONTENTS (continued)

TEST PAGE

Neisseria gonorrhoeae Culture 22

Neisseria meningitidis 22

Norovirus 23

Ova & Parasites (O&P) 23

Parasite Examination (worms, suspicious material, etc.) 23

Pertussis Culture 3

Pertussis PCR - B. pertussis, B. parapertussis, B holmseii 3

Pinworm 24

Quantiferon®-TB Gold In-Tube Test (M. tuberculosis) 13

Rubella IgG Antibody 24

Rubella IgM Antibody 25

Salmonella spp. 25

Shigella spp. 25

Syphilis (RPR) (screen) 26

Syphilis Fluorescent Treponemal Antibody-Absorption (FTA-ABS) 27

Syphilis VDRL 27

Tularemia Total Antibody 28

Varicella IgG Antibody 28

Vibrio spp. 29

Worm Identification – Refer to Parasitic Examination 23

Yersinia enterocolitica 29

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Bordetella species Culture

Isolation and identification of Bordetella species

including Bordetella pertussis and Bordetella parapertussis.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

Culture

No B. pertussis recovered, No B.

parapertussis recovered

Nasopharyngeal swab: Place

swab into Regan Lowe transport

tube (VDHL Kit #5). Ensure

swab is completely

submerged.

2-8°C must be received within 4

days of collection.

Monday-Saturday

7 days

87070/87077

Bordetella species PCR

Bordetella DNA qualitative real-time PCR.

●

This test detects Bordetella pertussis, Bordetella

parapertussis, and Bordetella holmseii.

The performance characteristics of the polymerase

chain reaction (PCR) test for Bordetella was

validated by the Vermont Department of Health

Laboratory. The U.S. Food and Drug

Administration (FDA) has not approved or cleared

this test. The results are not intended to be used as

the sole means for clinical diagnosis or patient

management decisions.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

PCR

No B. pertussis, B.

parapertussis, or

B. holmseii DNA detected

Dacron or Copan Flocked

nasopharyngeal swab: Place swab

into Regan Lowe transport tube

(VDHL Kit #5). Ensure swab is

completely

submerged.

2-8°C must be received within 4

days of collection

Mondays and Thursdays, or as

needed.

Within 1 working day

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Brucella Total Antibody

Brucella titers of 1:80 to 1:160 are strongly suggestive

of Brucellosis. However, a progressive increase in

titer between acute and convalescent specimens is the

prime evidence of recent infection. Confirmation of

serodiagnosis requires demonstration of a fourfold

titer difference between acute and convalescent

specimens taken at appropriate times.

Cross-reactions may occur between Brucella abortus

and Francisella tularensis antigens and antisera.

Therefore, both assays will be run on each specimen.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

Agglutination

≤1:20

1.0mL serum

(VDHL Kit #13/14)

-20°C (dry ice)

Monday-Wednesday as needed

Within 3 working days

86622

Campylobacter jejuni

Isolation and/or identification of Campylobacter spp.

This test may be ordered individually or as part of the

Enteric Screen, which includes the enteric pathogens

Campylobacter, Salmonella, Shigella, Yersinia

enterocolitica, E. coli O157:H7, and non-O157:H7

Shiga-toxin producing E. coli.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

Culture

No C. jejuni recovered

Stool preserved in Cary-Blair

based transport media

(VDHL Kit #1)

Isolate preserved in Cary-Blair

(VDHL Kit#1)

Room temperature, must be

received within 3 days from date of

collection

Monday-Saturday

Stool: 3 days from date of receipt

Isolate: 1-2 days from date of

receipt

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Chlamydia trachomatis and Neisseria gonorrhoeae

Single specimens are tested for both organisms.

This assay should not be used for test-of-cure

specimens. See Neisseria gonorrhoeae

Culture for test of cure specimens. Culture

for Chlamydia trachomatis is not available at

the VDHL.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

Nucleic Acid Amplified Test

Negative for C. trachomatis

Negative for N. gonorrhoeae

Gen-Probe Aptima Combo 2 assay

collection kit (urine or swab)

(VDHL Kit #7)

2-25°C within 60 days of

collection for swabs; 30 days for

urine specimens

Monday and Thursday

Within 2-4 working days

87801

Cryptosporidium parvuum

Enzyme immunoassay for Cryptosporidium parvuum.

This assay should not be used for test-of-cure

specimens.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

EIA

Negative

Stool in Total-Fix (VDHL Kit #2),

SAF, Cary-Blair liquid based

transport media (VDHL Kit #1), or

10% buffered formalin. Specimen

is acceptable for up to two months

in Total-Fix, SAF, and 10%

formalin. Specimen is acceptable

for 4 days in Cary-Blair based

media.

Room temperature

Monday, Wednesday, Friday

Within 1 working day

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Cyclospora spp.

Identification of Cyclospora spp. in stool.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

Acid-fast stain

No Cyclospora seen

Stool in Total-Fix (VDHL Kit #2),

SAF, or 10% buffered formalin.

Specimen is acceptable for up to

two months in these preservatives

Room temperature

As needed

Within 1 working day

88312

E. coli O157:H7

Isolation and Identification of E. coli O157:H7

This test may be ordered individually or as part of the

Enteric Screen, which includes the enteric pathogens

Campylobacter, Salmonella, Shigella, Yersinia

enterocolitica, E. coli O157:H7, and non-O157:H7

Shiga-toxin producing E. coli.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

Culture

No E. coli O157:H7 isolated

Stool preserved in Cary-Blair

based transport media

(VDHL Kit #1)

Isolate on agar slant (VDHL Kit#4)

Room temperature, must be

received within 3 days from date

of collection

Monday – Friday

Stool: 3 days from date of receipt

Isolate: 2 days from date of receipt

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E. coli Shiga-like Toxin

For the detection of Shiga-like Toxins I and II

(Verotoxins) in stool specimens.

This test may be ordered individually or as part of the

Enteric Screen, which includes the enteric pathogens

Campylobacter, Salmonella, Shigella, Yersinia

enterocolitica, E. coli O157:H7, and non-O157:H7

Shiga-toxin producing E. coli.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

EIA

Negative

Stool preserved in Cary-Blair

based transport media

(VDHL Kit #1)

MacConkey Broth inoculated with

200μL of stool and incubated at

37°C for 24 hours.

Room temperature: must be

received within 3 days from the

date of collection

Monday, Wednesday, Friday

Within 1 working day

87427

Enteric Screen

Culture for Salmonella, Shigella, Campylobacter,

Yersinia enterocolitica, E. coli O157:H7, and

non- O157:H7 Shiga-toxin producing E. coli.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

Culture

No pathogens isolated

Stool preserved in Cary-Blair

based transport media

(VDHL Kit #1)

Room temperature: must be

received within 3 days from date of

collection

Monday – Saturday

3 days from date of receipt

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Giardia

Enzyme immunoassay for Giardia intestinalis (syn.

lambia).

This assay should not be used for test-of-cure

specimens.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

EIA

Negative

Stool in Total-Fix (VDHL Kit #2),

SAF, Cary-Blair liquid based

transport media (VDHL Kit #1), or

10% buffered formalin. Specimen

is acceptable for up to two months

in Total-Fix, SAF, and 10%

formalin. Specimen is acceptable

for 4 days in Cary-Blair based

media.

Room Temperature

Monday, Wednesday, Friday

Within 1 working day

87329

Gonorrhea Culture

Culture and identification of Neisseria gonorrhoeae,

used for test-of-cure patients or in case of suspect

sexual assault.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

Culture

No N. gonorrhoeae recovered

Inoculated Jembec plate

(VDHL Kit #8).

Incubate plates 16-18 hours at

37°C prior to sending or deliver to

laboratory w/n 1 hour of collection.

Do not refrigerate.

As needed

3 days from date of receipt

87077

Haemophilis influenzae

Culture and identification of Haemophilis influenzae

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

Culture

No H. influenzae identified

Pure isolate

Room temperature

As needed

1 working day

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Hepatitis B Panel

Includes:

● Hepatitis B surface Antigen

●

Hepatitis B core Total Antibody

●

Hepatitis B surface Antibody

When determining disease state, no single result

should be used alone but in conjunction with the

other Hepatitis B serological markers.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

EIA

Non-reactive

1.5mL serum (VDHL Kit#13/14)

2-8°C. Serum must be

received within 48 hours of

collection.

Monday and Thursday

1-4 working days

87340/86706/86704

Hepatitis B Core Total Antibody (IgG and IgM) (Total Anti-HBc)

Specimens reactive for Hepatitis B Core Total

Antibody are also tested for Hepatitis B Core IgM.

When determining disease state, no single result

should be used alone but in conjunction with other

Hepatitis B serological markers.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

EIA

Non-reactive

1.0mL serum (VDHL Kit #13/14)

2-8°C. Serum must be

received within 48 hours of

collection.

Monday and Thursday

1-4 working days

86704

Hepatitis B Core IgM (IgM Anti-HBc)

*Only performed on specimens reactive for Hepatitis

Core Total antibody.

When determining disease state, no single result

should be used alone but in conjunction with other

Hepatitis B serological markers.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

EIA

Non-reactive

1.0mL serum (VDHL Kit #13/14)

2-8°C. Serum must be

received within 48 hours of

collection.

As needed

1-4 working days

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Hepatitis B Surface Antibody (Anti-HBs)

When determining disease state, no single result

should be used alone but in conjunction with other

Hepatitis B serological markers.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

EIA

Non-reactive

1.0mL serum (VDHL Kit #13/14)

2-8°C. Serum shipped at

ambient temperature received

within 48 hours of collection.

Monday and Thursday

1-4 working days

86706

Hepatitis B Surface Antibody Quantitation for Immune Response

A reactive result indicates a Hepatitis B Surface

Antibody level greater than 10 mLU/mL. This level is

generally considered to indicate protective immunity.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

EIA

Non-reactive

1.0mL serum (VDHL Kit #13/14)

2-8°C. Serum must be

received within 48 hours of

collection.

Monday and Thursday

Within 1-4 working days

86706

Hepatitis B Surface Antigen

Repeatedly Reactive HBsAg results are confirmed by

neutralization.

When determining disease state, no single result

should be used alone but in conjunction with other

Hepatitis B serological markers.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

EIA

Non-reactive

1.0mL serum (VDHL Kit #13/14)

2-8°C. Serum must be received

within 48 hours of collection.

Monday and Thursday

Within 1-4 working days

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Hepatitis C Antibody (Screen)

Samples with high s/co ratios usually (95%) confirm

positive, but < 5 of every 100 might represent false-

positives; more specific testing can be requested, if

indicated.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

EIA

Non-reactive

1.0mL serum (VDHL Kit #13/14)

Whole blood shipped at up to

25°C within 24 hours. Serum

shipped up to 37°C and

received within 7 days of

collection

Tuesday and Thursday

Within 1-3 working days

86803

HIV-1 Oral Fluid

Confirmatory HIV-1 Oral Fluid western blot

testing will be performed on HIV-1 Oral

Fluid EIA repeatedly reactive specimens.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

EIA

Non-reactive

Oral mucosal exudates collected

with the OraSure collection kit.

2-37°C and received within 19 days

of collection.

Monday, Wednesday, Friday

Within 1-3 working days for those

specimens not needing repeat

testing.

86701

HIV-1 Oral Fluid Western Blot

Confirmation test for HIV-1.

Performed on all HIV-1 Oral Fluid repeatedly

reactive results.

For HIV-1 western blot test only requests: Please

include screen test results on the requisition form.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

Western Blot

Negative

Oral mucosal exudates collected

with the OraSure collection kit.

2-37°C and received within 19 days

of collection.

As needed

Within 2 working days.

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HIV-1/HIV-2 (Screen)

Qualitative detection of acute and primary infection for

HIV-1/HIV-2 Ab and HIV-1 p24 Ag.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

Combo Ag/Ab EIA

Non-reactive

1.0mL serum (VDHL Kit #13/14)

Serum may be stored for ≤ 2 days

at room temperature or for 7 days

a t 2-8°C including the time those

samples are in transit.

Monday, Wednesday, Friday

Within 3 working days

87389

HIV-1/HIV-2 Ab Differentiation Immunoassay

HIV-1/HIV-2 Ab Differentiation Immunoassay will

be performed on all HIV-1/HIV-2 EIA repeatedly

reactive specimens.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

Immunoassay Rapid Quantitative

Negative

1.0mL serum (VDHL Kit #13/14)

Serum shipped at ambient

temperature within 2 days of

collection or shipped 2-8°C

within 5 days of collection.

As needed

Within 3 working days

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Interferon Gamma Release Assay (IGRA) / Cellestis QuantiFeron®-TB Gold In-Tube test - M. tuberculosis

The Cellestis QuantiFeron®-TB Gold In-Tube test

(QFT-

GIT) is a qualitative laboratory test using whole

blood specimens. The QFT-GIT test can be used to

assess for the presence of latent tuberculosis infection

(LTBI) or to aid in the diagnosis of active tuberculosis

(TB). The QFT-GIT test cannot distinguish between

LTBI and active TB, so the test should be used in

conjunction with risk assessment, radiography, and

other medical and diagnostic evaluations. The QFT-

GIT should not be used exclusively in diagnosing

tuberculosis or for patients currently receiving

treatment for active or LTBI.

QFT-GIT testing can be performed by the VDHL if

the following applies:

• Persons who have received the BCG vaccine and

ave had contact with persons known to have active

TB or are suspected to have active TB.

• Close contacts of persons known or suspected to

have active TB.

• Foreign-born persons from areas that have a high

incidence of active TB.

• People who have had frequent or prolonged visits to

areas with a high prevalence of active TB

• Persons considered at risk for TB/LTBI and may not

return to have the TST read.

• Persons who have received BCG (either as a vaccine

or for cancer therapy). The VDHL does not require

documented BCG as a vaccine. If an individual is

from a country where a patient is suspected to have

received the vaccine, QFT-GIT will be considered

the preferred test.

• Persons from groups that historically have poor

rates of return for TST reading.

Test Type:

Reference Range:

Specimen Requirements:

Set up:

Transport Temperature:

Results Available:

CPT Code:

Enzyme-Linked Immunosorbent

Assay (ELISA)

Negative

0.8-1.2mL blood in

QuantiFERON-QTB Gold In-

Tube Collection Kit

(VDHL Kit

#10)

As needed

Incubated specimens: ship at

4-27°C.

Must be received within 3

days from date of collection.

Non-incubated specimens: ship at

17-27°C. Must be received within

16 hours from time of collection.

Within 1 working day

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Influenza A/B PCR (For Surveillance Purposes Only)

● Detection of Influenza A or Influenza B.

● Subtyping will be performed on all positive

Influenza A specimens. The following subtypes can

be detected:

- H1N1 (Seasonal)

- H3N2 (Seasonal)

- 2009 H1N1

- H3N2 variant (Swine-origin triple reassortant

virus)

● Specimens accepted from Sentinel Providers, Early

Aberration Reporting System (EARS) Providers,

Long Term Care Facilities or other Institutions.

● Suspect cases of Pandemic or Avian Influenza will

be accepted for PCR testing with prior approval

from Epidemiology (1-800-640-4374 or 802-863-

7240).

●

Specimens also accepted from providers with

special circumstances (e.g. a patient with a

serious illness or complication that might be

due to influenza or a patient who is

hospitalized with an influenza-like illness).

Specimens will NOT be tested without the following

information:

•

Travel history

•

Date of collection

•

Date of onset

•

Vaccination history

•

Swabs with calcium alginate or cotton tips and

wooden shafts

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results

Available: CPT Code:

RT-PCR

Influenza A virus RNA not

detected, Influenza B virus RNA

not detected

Nasopharyngeal swabs (preferred),

nasal swabs, throat swabs, dual

nasopharyngeal/throat swabs

Additional sites include Nasal

aspirates, Nasal washes,

Bronchoalveolar lavage, Bronchial

wash, Tracheal aspirate, Sputum

(VDHL Kit #9).

2-8 °C to arrive within 3 days of

collection or freeze specimen at

-70°C and ship on dry ice. Time in

transit should not exceed 24

hours.

Tuesday and Friday or as needed

1-4 working days

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Lead, Adult Blood (Diagnostic)

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

Graphite Furnace Atomic

Absorption

<40.0μg/dL

100.0μL minimum whole blood;

EDTA anticoagulant

Refrigerate when not in transit

(Recommended)

Monday – Thursday

Within 7 working days

83655

Lead, Childhood Blood (Diagnostic)

Test Type:

Reference Range:

Specimen Requirements:

Set up:

Transport Temperature:

Results Available:

CPT Code:

Graphite Furnace Atomic

Absorption

<10.0μg/dL

100.0μL minimum whole blood;

EDTA anticoagulant

Monday – Thursday

Refrigerate when not in transit

(Recommended)

Within 7 working days

83655

Legionella Culture

Isolation and identification of Legionella pneumophila

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Results Available:

CPT Code:

Culture

No L. pneumophila recovered

Sputum, pleural fluid, transtracheal

aspirates, bronchial washings.

(VDHL Kit #6)

2-8°C within 3 days of collection.

If more than 3 days, ship frozen on

dry ice.

7 days

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Legionella IgG Antibody

Legionella pneumophila serogroups 1-6

•

A positive is presumptive supporting evidence

of exposure

•

Solid evidence for a diagnosis of legionellosis is

obtained when sero-conversion occurs with

paired sera

•

Performed by a Reference Laboratory

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

ELISA

Negative

0.5mL serum (VDHL Kit #13/14)

2-25°C. Serum received within 48

hours of collection.

As Needed

Within 5-7 working day

86713

Legionella Urine Antigen

Legionella pneumophila serogroup 1

Results are reported as presumptive only.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

Immunochromatographic

membrane assay

Presumptive Negative

Urine collected in standard

containers.

15-30°C if received within 24

hours of collection or 2-8°C if

received within 14 days of

collection.

As needed

1 working day

87450

Listeria spp.

Culture and identification of Listeria spp.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

Culture

No Listeria identified

Pure isolate

Room temperature

As needed

3 days from date of receipt

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Measles (Rubeola) IgG Antibody (Diagnostic)

*Specimen: 1.0mL of acute (at onset of symptoms)

and convalescent (2 weeks later) serum. A four-fold

or greater rise in antibody titer or seroconversion is

indicative of a primary or recent measles (Rubeola)

infection.

Report all suspect Measles cases to Epidemiology at 1-

800-640-4374 or 863-7240 before submitting

specimens.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

EIA

Measles IgG antibody not detected

1.0mL Acute serum*

1.0mL Convalescent serum*

(VDHL Kit #13/14)

2-8°C. Specimen should be

received at VDHL within 2 days.

As needed

1 working day

86765

Measles (Rubeola) IgG Antibody (Immune status)

A reactive result indicates immunity to Rubeola

infection.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

EIA

Measles IgG antibody not detected

1.0mL (minimum 0.25mL) serum

(VDHL Kit #13/14)

2-8°C. Specimen should be

received at VDHL within 2 days.

Tuesday and Friday

Within 1-4 working days

86765

Measles (Rubeola) IgM Antibody (Diagnostic)

Report all suspect Measles cases to Epidemiology at 1-

800-640-4374 or 863-7240 before submitting

specimen.

*1.0mL serum drawn at least 3 days after rash

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

Capture EIA

Measles IgM antibody not detected

1.0mL serum* (VDHL Kit#13/14)

2-8°C. Specimen should be

received at VDHL within 2 days.

As needed

1 working day

86765

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Measles (Rubeola) Real Time Reverse Transcriptase PCR (rRT-PCR)

Order this test if an active case of Measles is suspected.

Report all suspect cases to Epidemiology at

1-800-640-4374 or 802-863-7240 prior to submitting

specimen.

The performance characteristics of the Centers for Disease

Control and Prevention (CDC) rRT-PCR test for Measles

were validated by the Vermont Department of Health

Laboratory. The U.S. Food and Drug Administration (FDA)

has not approved or cleared this test. The results are not

intended to be used as the sole means for clinical diagnosis

or patient management decisions.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

Real Time RT-PCR

Measles RNA not detected

Synthetic oropharyngeal, nasal or

nasopharyngeal swab: place swab

into

viral transport medium (Kit #

11). Ensure swab is completely

submerged.

Urine: >50.0mL in a sterile, leak-

proof container (requires prior

approval).

4°C. and must be received within

24 hours or frozen at

-70°C or colder.

Day of receipt or next working day if

received after 12:00pm.

Same day or next working day if

received after 12:00pm.

87798

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19 of 30

Mumps IgG antibody (Immune status)

A reactive result indicates immunity to Mumps

infection.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

EIA

Mumps antibody not detected

1.0mL (minimum 0.25mL) serum

(VDHL Kit #13/14)

2-8°C. Serum should be received

at VDHL within 48 hours of

collection.

Tuesday and Friday

Within 1-4 working days

86735

Mumps Real Time Reverse Transcriptase PCR (rRT-PCR)

Order this test if an active case of Mumps is suspected.

Report all suspect cases to Epidemiology at

1-800-640-4374 or 802-863-7240 prior to submitting

specimen.

The performance characteristics of the Centers for Disease

Control and Prevention (CDC) rRT-PCR test for Mumps

were validated by the Vermont Department of Health

Laboratory. The U.S. Food and Drug Administration

(FDA) has not approved or cleared this test. The results

are not intended to be used as the sole means for clinical

diagnosis or patient management decisions.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

Real Time RT-PCR

Mumps N Gene RNA not detected

Buccal swab or oropharyngeal swab

(Kit # 11)

4°C. and must be received

within 24 hours or frozen at

-70°C or colder

Day of receipt or next working day

if received after 12:00pm.

Same day or next working day if

received after 12:00pm.

87798

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Mycology

•

Mycology specimens are accepted only as

specimens submitted for mycobacterial

analysis.

•

Filamentous fungi are referred to a

reference laboratory for identification.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

Culture

No yeast recovered

Sputum: > 3.0mL (VDHL Kit #6)

CSF: > 2.0mL

Tissue: Sterile container with a

small amount of sterile saline

Blood: Collect 5mL or more in

SPS tube. Do not use sodium

heparin as an anti- coagulant

Pleural fluid: > 2.0mL

Bronchial wash /lavage: > 2.0mL

Swab specimens will not be

accepted

2-8°C for respiratory specimens, all

others room temperature.

As needed

21-28 days

87102

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21 of 30

Mycobacteria

•

Standard procedures are used for the staining

and culture of all Mycobacteria.

•

Specimens are inoculated to both solid and

liquid media using conventional and

automated rapid broth system.

•

Acid fast bacilli growing in culture are

identified by both DNA probe and

biochemical identification methods.

•

AFB positive smear specimens are

automatically tested by Nucleic Acid

Amplification for Mycobacterium tuberculosis

complex.

•

Specimens are set up Monday –Friday and

smear results are faxed to the provider the

same day as specimen receipt.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature

Set up:

Results Available:

CPT Code:

(see left)

Smear: No acid-fast bacilli seen

Culture: No Mycobacteria

recovered

Sputum: > 3.0mL, three

consecutive specimens (VDHL

Kit #6)

CSF: > 2.0mL (VDHL Kit #6)

Tissue/Lymph Node: Sterile

container with a small amount of

sterile saline (VDHL Kit #6)

Blood: Collect in SPS or Heparin

tube.

Do not use EDTA or ACD tube.

Pleural and other

body fluids: > 3.0mL

(VDHL Kit #6)

Bronchial wash /lavage: > 2.0mL

(VDHL Kit #6)

Urine: >40.0mL. First morning,

clean catch. Catheter collections

preferred.

Do not pool

specimens or use midstream urine.

(VDHL Kit #6)

Abscess: Surface exudates in Luer

tip syringe, tissue, aspirates.

Swab specimens will not be

accepted.

2-8°C for respiratory specimens and

urine. Room temperature for all

others.

Monday – Friday

Culture results : 6 weeks

Smear results available same day

of receipt (except weekends)

Nucleic Acid Amp: 24 hours

Culture: 87118

Acid-Fast Smear: 87206

Nucleic acid Amp: 87556

Clinical Lab Services Manual

Clinical Tests Available

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22 of 30

Mycobacterium tuberculosis Amplified Direct Test

●

GEN-PROBE® AMPLIFIED™ Mycobacterium

Tuberculosis Direct (MTD) Test detects M.

tuberculosis complex rRNA in both smear positive

and smear negative respiratory sediments prepared

using NALC-NaOH decontamination. The MTD is

intended for use only with specimens from patients

showing signs and symptoms consistent with active

pulmonary tuberculosis. Patients suspected of

having pulmonary TB who have had less than 7

days of anti-tuberculosis therapy, or have not

received such therapy in the last 12 months may be

evaluated.

● Grossly bloody specimens are NOT recommended

and may result in invalid results.

● This test is automatically performed on all

respiratory specimens that are AFB smear positive.

● Performance of the MTD test with clinical

specimens other than respiratory specimens has not

been established by the manufacturer or the

Vermont Department of Health Laboratory.

● Please contact the VDHL prior to sending the

specimen.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

Nucleic Acid Amplification Test

Negative for M. tuberculosis

complex RNA

Sputum: > 3.0mL (VDHL Kit #6).

Bronchial wash /lavage: > 3.0mL

(VDHL Kit #6).

Respiratory Sediments: 1mL

required. Must be received within

72 hours of

digestion/decontamination. Store

at 2-8°C until shipped.

Specimens must be sent at 2-8°C

and received within 72 hours of

collection.

As needed

24 hours

87556

M. tuberculosis Antimicrobial Susceptibility AFB Primary Drug Panel

M. tuberculosis drug panel includes:

- Ethambutol, Isoniazid, Rifampin by the

VersaTrek Myco Susceptibility Kit. PZA testing

performed by a reference laboratory.

Specimens can be forwarded to the CDC for

rapid confirmation of MDR-TB through the

identification of genetic mutations associated with

Rifampin and Isoniazid resistance. Mutations

associated with resistance to the most effective

second line drugs are also examined.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

(see left)

By report

Culture: safely contained on solid

media.

Room temperature

As needed

14-21 days

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23 of 30

Neisseria gonorrhoeae and Chlamydia trachomatis

Single specimens are tested for both organisms.

This assay should not be used for test-of-cure

specimens. See Neisseria gonorrhoeae

Culture for test of cure specimens. Culture

for Chlamydia trachomatis is not available at

the VDHL.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

Nucleic Acid Amplified Test

Negative for C. trachomatis

Negative for N. gonorrhoeae

Gen-Probe Aptima Combo 2 assay

collection kit (urine or swab)

(VDHL Kit #7)

2-25°C within 60 days of

collection for swabs, 30 days for

urine specimens

Monday and Thursday

Within 2-4 working days

87801

Neisseria gonorrhoeae Culture

Culture and identification of Neisseria gonorrhoeae,

used for test-of-cure patients or in case of

suspect sexual assault.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

Culture

No N. gonorrhoeae recovered

Inoculated Jembec plate

(VDHL Kit #8).

Incubate plates 16-18 hours at

37°C prior to sending or deliver to

laboratory w/n 1 hour of collection.

Do not refrigerate.

As needed

3 days from date of receipt

87077

Neisseria meningitides

Identification/confirmation and serotyping of Neisseria

meningitidis

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

Identification/confirmation and

serotyping

No N. meningitides identified

Pure isolate on Chocolate slant

Room temperature

As needed

24 hours from date of receipt

87040/87077

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Clinical Tests Available

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24 of 30

Norovirus

For investigational use only.

Please contact Epidemiology at 1-800-640-4374 or

802-863-7240 before

submitting specimens.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

PCR

No Norovirus nucleic acid detected

Raw stool (VDHL Kit #23)

2-8°C within 24 hours of collection

As needed

2 working days

87798

Ova & Parasites (O&P)

Cryptosporidium and Cyclospora are not detected with

this method. Refer to Cryptosporidium and Cyclospora

listed in this test catalog for the correct test method.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

Microscopic examination

No parasites seen

Stool in Total-Fix (VDHL Kit #2),

SAF, or 10% buffered formalin.

Specimen is acceptable for up to

two months in these preservatives.

Room temperature

Monday – Friday

Within 1 working day

88313

Parasite Examination

Gross identification of parasites (e.g. worms) and

suspect material passed in stool.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

Varies

Descriptive report provided

Submit specimen in Total-Fix

preservative (VDHL Kit#2)

Room temperature

Monday-Friday

1-7 days

87070/87077

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Clinical Tests Available

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25 of 30

Pinworm

Identification of Enterobius vermicularis (Pinworm).

Collection of the specimen should occur first thing

in the morning, prior to rising.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

Microscopic exam

No pinworm seen

Pinworm paddle (VDHL Kit #17).

Room temperature

As needed

Within 24 hours

87172

Rubella IgG Antibody

•

Patient Rubella IgG results equal to or greater

than 10 IU/mL indicate past exposure to either

rubella virus or vaccine, and probable protection

from clinical infection.

•

Antibody levels less than 10 IU/mL may be

insufficient to provide protection from

rubella virus infection.

•

For diagnosis of current or recent rubella

infection, obtain paired sera (acute and

convalescent). The acute specimen should be

collected as soon as possible after the onset of a

rash or at the time of exposure. The

convalescent specimen should be

obtained from 10-21 days after the onset of a rash

or at least 30 days after exposure in the absence

of clinical symptoms associated with a rubella

infection. A four-fold or greater rise in

antibody titer or seroconversion is indicative of

a primary or recent rubella infection.

•

Seroconversion may also be seen after a

vaccination procedure. Some persons

previously exposed to rubella may

demonstrate a rise in antibody titer. This is

thought to represent re-infection and these

patients rarely develop symptoms.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

Latex Agglutination

Rubella IgG antibodies

<10 mIU/mL

0.5mL serum (VDHL Kit #13/14)

2-8°C. Specimen should be received

at VDHL within 48 hours.

Monday, Wednesday, Friday

Within 1-3 working days

86762

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Clinical Tests Available

http//:healthvermont.gov

26 of 30

Rubella IgM Antibody

Report all suspect cases to Epidemiology at

1-800-640-4374 or 863-7240 prior to submitting

specimen.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

EIA

Rubella IgM antibody not detected

1.0mL serum (VDHL Kit #13/14)

2-8°C. Serum specimen should

be received at VDHL within 48

hours.

As needed

1 day (verbal), 3 days(written)

86762

Salmonella spp.

Isolation and identification of Salmonella spp.

This test may be ordered individually or as part of the

Enteric Screen,which includes the enteric pathogens

Campylobacter, Salmonella, Shigella, Yersinia

enterocolitica, E. coli O157:H7, and non-O157:H7

Shiga-toxin producing E. coli.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results Available:

CPT Code:

Culture

No Salmonella recovered

Stool preserved in Cary-Blair based

transport media (VDHL Kit#1)

Isolate on agar slant (VDHL Kit#4)

Room temperature must be received

within 3 days from date of collection.

Monday-Saturday

Stool: 3 days from date of receipt

Isolate: 3-7 days from date of receipt

87045/87077

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Clinical Tests Available

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27 of 30

This test may be ordered individually or as

part of the Enteric Screen, which includes

the enteric pathogens Campylobacter,

Salmonella, Shigella, Yersinia enterocolitica,

E. coli O157:H7, and non-O157:H7 Shiga-

toxin producing E. coli.

Shigella spp. (see also Enteric Screen)

Isolation and identification of Shigella spp. Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up:

Results available:

CPT Code:

Culture

No Shigella recovered

Stool preserved in Cary-Blair based

transport media (VDHL Kit #1).

Isolate on agar slant (VDHL Kit#4).

Room temperature: must be

received within 3 days from date of

collection

Monday – Saturday

Stool: 3 days from date of receipt

Isolate: 3-7 days from date of receipt

87045/87077

Syphilis (RPR) (screen)

The Rapid Plasma Reagin (RPR) is a macroscopic,

nontreponemal screening procedure for the

serologic detection of syphilis.

Reactive RPR specimens are quantitated and a FTA-

ABS test is performed to confirm reactive RPR

results.

Test Type:

Reference Range:

Specimen Requirements:

Transport Temperature:

Set up: Results

Available:

CPT Code:

Agglutination

Non-reactive

0.5mL serum (VDHL Kit #13/14)

2-8°C. Specimen should be

received at VDHL within 48

hours.

Monday, Wednesday, Friday

Within 4 working days for

negative results

86592

Syphilis Fluorescent Treponemal Antibody-Absorption (FTA-ABS)

Clinical Lab Services Manual

Clinical Tests Available

http//:healthvermont.gov

28 of 30

FTA-ABS test has never been and is not now

being recommended as a routine screening test for

syphilis. Its recommended use is to confirm the

reactive results of a sensitive, but less specific

screening test for syphilis, such as the RPR as a

specific diagnostic test in patients with signs or

symptoms suggestive of late syphilis.

Test Type:

Reference Range:

Specimen Requirements:

Set up:

Transport Temperature:

Results Available:

CPT Code:

Indirect Fluorescent Antibody

Non-reactive

0.5mL serum (VDHL Kit #13/14) As

needed

2-8°C. Specimen should be received at

VDHL within 48 hours.

Within 1-4 working days

86781

Syphilis VDRL

The Venereal Disease Research Laboratory (VDRL) test

is a slide micro-flocculation test for syphilis.

Test Type:

Reference Range:

Specimen Requirements:

Set up:

Transport Temperature:

Results Available:

CPT Code:

Flocculation

Non-reactive

0.5mL Cerebrospinal Fluid

(CSF) ONLY

As needed

2-8°C. Specimen should be

received at VDHL within 48 hours.

Within 1-3 working days

86592

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29 of 30

Tularemia Total Antibody

•

A single titer of 1:20 or below are usually not

diagnostic for infection with Francisella

tularensis

•

Tularemia titers of 1:160 are strongly

suggestive of Tularemia. However, a

progressive increase in titer between acute

and convalescent specimens is the prime

evidence of recent infection. Confirmation

of serodiagnosis requires demonstration of a

four-fold titer difference between acute and

convalescent specimens taken at

appropriate times.

Cross-reactions may occur between Brucella abortus

and Francisella tularensis antigens and antisera.

Therefore, both assays will be run on one specimen.

Test Type:

Reference Range:

Specimen Requirements:

Set up:

Transport Temperature:

Results Available:

CPT Code:

Agglutination

<1:20

1.0mL serum (VDHL Kit #13/14)

Monday – Wednesday as needed

-20°C (dry ice)

Within 4 working days

86668

Varicella IgG Antibody

A reactive result indicates immunity to

Varicella infection

Test Type:

Reference Range:

Specimen Requirements:

Set up:

Transport Temperature:

Results Available:

CPT Code:

EIA

Varicella antibody not detected

1.0mL (minimum 0.25mL) serum

(VDHL Kit #13/14)

Tuesday and Friday

2-8°C. Specimen should be

received at VDHL within 48 hours.

Within 1-4 working days

86787

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Clinical Tests Available

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30 of 30

Vibrio spp.

Isolation and identification of Vibrio spp. Test Type:

Reference Range:

Specimen Requirements:

Set up:

Transport Temperature:

Results Available:

CPT Code:

Culture

No Vibrio isolated

Stool preserved in Cary-Blair based

transport media (VDHL Kit #1)

As needed

Room temperature: must be

received within 3 days from date of

collection

3 days from date of receipt

87046/87077

Yersinia enterocolitica (see also Enteric Screen)

Isolation and identification of Yersinia enterocolitica.

This test may be ordered individually or as part of the

Enteric Screen, which includes the enteric pathogens

Campylobacter, Salmonella, Shigella, Yersinia

enterocolitica, E. coli O157:H7, and non-O157:H7

Shiga-toxin producing E. coli.

Test Type:

Reference Range:

Specimen Requirements:

Set up:

Transport Temperature:

Results Available:

CPT Code:

Culture

No Y. enterocolitica isolated

Stool preserved in Cary-Blair

based transport media

(VDHL Kit #1)

Monday – Saturday

Room temperature: must be

received within 3 days from date of

collection

3 days from date of receipt

87045/87077

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