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ENA Antibody Screen with reflex

Test Includes:

Viruses Included in Panel

Organisms Included in Panel

Test Utility

Extractable Nuclear Antigen (ENA) antibody screen, (EliA SymphonyS ) is intended for the in vitro, qualitative measurement of antinuclear IgG antibodies in human serum. EliA SymphonyS is based on recombinant U1RNP, RNP70(70kDa, A, C), SS-A/Ro (60 kDa, 52 kDa), SS-B/La, Centromere B, Scl-70, Jo-1 proteins and a synthetic SmD3 peptide as antigen and is useful as an aid in the clinical diagnosis of patients with systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), Sjögren’s syndrome, scleroderma and polymyositis/dermatomyositis, in conjunction with other laboratory and clinical findings.

Urine Drug Screen Profile Includes:

Methodology

Immunoassay, Fluorescent; EliA method

Methodology

Screen Test Name
Assay Type
ETG
DRI
Amphetamine
DRI
Barbiturates
DRI
Benzodiazepine
DRI
Cotinine
DRI
Cocaine
DRI
Methadone
DRI
Opiate
DRI
Oxycodone
DRI
THC
DRI
Fentanyl
DRI
Buprenorphine
CEDIA

Individual Test Information Including Methodology & Reference Ranges

Reflex to UTI Criteria

Specimen Collection and Preparation

Collect serum in the following tubes:

  • Preferred Specimen: One Gold-top SST tube (Minimum serum volume: 1.0 mL)

  • Also Acceptable: Plain red top (Minimum serum volume: 1.0 mL)

  • Pour serum into plastic, pour off tube and label with patient identifiers as well as the source of serum (gold top or red top).

Specimen Storage and Stability

Sample should be centrifuged at 3000 rpm for 15 minutes within 1 hour of collection, and serum/plasma separated as soon as possible.


Serum specimens at the following temperatures:

  • Room temperature (20–26°C): 72 hours

  • Refrigerated (2–8°C): 1 week


Note: samples are stored at 2-8C for 7 days before disposal

Specimen Rejection

  • Improper/incomplete labeling

  • Quantity insufficient (QNS)

  • Incorrect sample type

Reference Range (Cutoff)

​

Screen Test Name
Screen Test Name Cutoff (ng/mL)
Cocaine
300

​

Screen Test Name
Screen Test Name Cutoff (ng/mL)
Benzodiazepine
200

​

Screen Test Name
Cutoff (ng/mL)
Buprenorphine
5

​

Screen Test Name
Screen Test Name Cutoff (ng/mL)
Amphetamine
500

​

Screen Test Name
Screen Test Name Cutoff (ng/mL)
Barbiturates
200

​

Screen Test Name
Screen Test Name Cutoff (ng/mL)
ETG
500

​

Screen Test Name
Screen Test Name Cutoff (ng/mL)
ETG
500

​

Screen Test Name
Screen Test Name Cutoff (ng/mL)
EDDP
100

​

Screen Test Name
Screen Test Name Cutoff (ng/mL)
Fentanyl
1

​

Screen Test Name
Screen Test Name Cutoff (ng/mL)
Methadone
300

​

Screen Test Name
Screen Test Name Cutoff (ng/mL)
PCP
25

​

Screen Test Name
Screen Test Name Cutoff (ng/mL)
Opiate
300

​

Screen Test Name
Screen Test Name Cutoff (ng/mL)
Oxycodone
300

​

Screen Test Name
Cutoff (ng/mL)
Methamphetamine
500

​

Screen Test Name
Cutoff (ng/mL)
THC
50

​

Screen Test Name
Cutoff (ng/mL)
ETG
500
Amphetamine
500
Barbiturates
200
Benzodiazepine
200
Cotinine
500
Cocaine
300
Methadone
300
Opiate
300
Oxycodone
300
THC
50
Fentanyl
1
Buprenorphine
5

Reference Range

The assay provides a numerical ratio and interpretative comments based on the numerical ratio: 


 <0.7 ratio = Negative; 0.7-1.0 ratio = Equivocal; >1.0 ratio = Positive


When the result of this test is Positive, the laboratory will reflex to add testing for the 8 individual markers listed above in the Test Utility section. 


Antibody prevalence in autoimmune patients varies widely depending on disease area.  The proportion of sera from normal population found positive for antibodies covered by this EliA Symphony test is below 1%.  Expected values may vary depending on the population tested.


It is recommended to repeat equivocal results, after 8-12 weeks.

Parameter 
Reference Range 
Glucose 
Negative 
Bilirubin 
Negative 
Ketones 
Negative 
Specific Gravity 
1.005 - 1.030 
Blood 
Negative 
pH 
5.0 - 8.0 
Protein 
Negative 
Urobilinogen 
0.0 - 1.0 mg/dL 
Nitrate 
Negative 
Leukocyte Esterase 
Negative 
Microscopic Evaluation 
WBC 
Negative 

​

Parameter
Reference Range
Microscopic Evaluation
WBC
Negative
RBC
Negative
Hylaine Casts
Negative
All other Parameters
Negative

​

Parameter
Reference Range
Glucose
Negative
Bilirubin
Negative
Ketones
Negative
Specific Gravity
1.005 - 1.030
Blood
Negative
pH
5.0 - 8.0
Protein
Negative
Urobilinogen
0.0 - 1.0 mg/dL
Nitrate
Negative
Leukocyte Esterase
Negative

​

CBC
Adult Male
Adult Female
Adult Female 10^3/uL
Adult Female %
WBC
3.5-10.5 10³/uL
3.5-10.5 10³/uL
RBC
4.32-5.72 10⁶/uL
3.9-5.03 10⁶/uL
HGB
13.5-17.5 g/dL
12.0-15.5 g/dL
HCT
38.8-50.0%
34.9-44.5%
MCV
81.2-95.1 fL
81.6-98.3fL
MCH
27-35 pg
27-35 pg
MCHC
31-36 g/dL
31-36 g/dL
RDW
11.8-15.6%
11.9-15.5%
PLT
150-450 10³/uL
150-450 10³/uL
Differential
Adult Male 10³/uL
Adult Male %
Neutrophils
1.7-7.0
55-70
1.7-7.0
55-70
Lymphocytes
0.9-2.9
20-40
0.9-2.9
20-40

​

CBC
Adult Male
Adult Female
WBC
3.5-10.5 10³/uL
3.5-10.5 10³/uL
RBC
4.32-5.72 10⁶/uL
3.9-5.03 10⁶/uL
HGB
13.5-17.5 g/dL
12.0-15.5 g/dL
HCT
38.8-50.0 %
34.9-44.5%
MCV
81.2-95.1 fL
81.6-98.3 fL
MCH
27-35 pg
27-35 pg
MCHC
31-36 g/dL
31-36 g/dL
RDW
11.8-15.6 %
11.9-15.5%
PLT
150-450 10³/uL
150-450 10³/uL

​

Test
Adult Male
Adult Female
ESR
0-10 mm/hr
0-20 mm/hr

​

CBC
Adult Male
Adult Female
HGB
13.5-17.5 g/dL
12.0-15.5 g/dL
HCT
38.8-50.0%
34.9-44.5%

​

Test
Adult Male
Adult Female
Reticulocyte Count
0.0216 – 0.0858 10^6/uL
0.0195 – 0.0755 10^6/uL

Testing Description

State Reportable Infection

Pediatric Range

Test Code

P-VHL-9120

Performed

Monday-Friday

Contacts

Vibra Health Laboratory

1307- A, Allen Dr

Troy, MI 48083

(248) 846-0663

Last Updated

3/30/26 v.1

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