Reference Values

No growth

See report.

See report.

Microalbumin/Creatinine ratio:  0 - 30 mg/g
 

0.0-0.2 Ratio

Negative
 
Drugs are screened by Immunoassay. Positive results are confirmed
by chromatography with mass spectrometry. The following threshold
concentrations are used for this analysis:
        \

No established reference values

Negative (reported as positive or negative)

Negative
 
Drugs are screened.
         Drug                Screening Threshold    
  Amphetamines             1000  ng/mL                      
  Barbiturates                    200 ng/mL                      
  Benzodiazepines            300 ng/mL                      
  Cocaine Metabolites       300 ng/mL                      
  Opiates                            300 ng/mL                     
  Phencyclidine (PCP)         25 ng/mL                      
  Cannabinoids                    50 ng/mL                      
  Methadone                      300 ng/mL                                                                                                                                                                                                                                                                                                                                                             Fentanyl                          1000ng/mL                                                                                                                                                                                                                                                                                                                                                  Oxycodone                    100 ng/mL 

Urine drug screens are performed using the cutoff levels listed. Results are considered presumptive, require clinical correlation, and may be subject to cross reactivity with other drugs or metabolites.  If clinically indicated, confirmatory testing may be separately ordered. The laboratory can supply a reference of cross reacting or interfering substances.
 
               THESE RESULTS SHOULD BE USED FOR MEDICAL PURPOSES ONLY AND NOT FOR ANY LEGAL OR EMPLOYMENT EVALUATIVE PURPOSES

Negative

No established reference values

No established reference values

Negative

No established reference values

No established reference values

Negative
 
Test Indudes: Ethyl glucuronide (EtG); Ethyl sulfate (EtS)

For throat, urine and genital specimens- No fungus isolated at 2 weeks.

For all other specimen sources-No fungus isolated at 4 weeks

See report.

The presence of a kidney stone is abnormal. A quantitative
report will be provided after analysis.

Calcium oxalate stones:

-Production of calcium oxalate stones consisting of oxalate dihydrate indicate that the stone is newly formed, and current urine constituents can be used to assess the importance of supersaturation.

-Production of calcium oxalate stones consisting of oxalate monohydrate indicate an old (>2 months since formed) stone, and current urine composition may not be meaningful.

Magnesium ammonium phosphate stones (struvite):

-Production of magnesium ammonium phosphate stones (struvite) indicates that the cause of stone formation was infection.

-Treatment of the infection is the only way to inhibit further stone formation.

Ephedrine/guaifenesin stones:

-Certain herbal and over-the-counter preparations (eg, Mah Jung) contain high levels of ephedrine and guaifenesin. Excessive consumption of these products can lead to the formation of ephedrine/guaifenesin stones.

See report.

No established reference ranges

This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Reference Range(s)
None detected

See Report
Drugs Measured:

6-Acetylmorphine; amphetamines; analgesics/NSAIDS; anesthetics (local); anticonvulsants; antidepressants; antihistamines; antipsychotics; barbiturates; benzodiazepines; buprenorphine; cocaine (and metabolite); ethyl alcohol (EtOH); fentanyl and analogues; methadone; miscellaneous; muscle relaxants; opiates; other hallucinogens; other opioids; oxycodone; sedative/hypnotics; sympathomimetics; tapentadol; tetrahydrocannabinol (THC); creatinine.

 The drugs in this panel screened by immunoassay and if positive confirmed by GC/MS or LC/MS/MS at the following threshold concentrations: Drug Screen Confirmation Amphetamine 50 ng/ml 10 ng/ml Barbiturates 100 ng/ml 200 ng/ml Benzodiazepines 20 ng/ml See individual drug Cocaine 25 ng/ml 30 ng/ml Methadone 25 ng/ml 50 ng/ml Opiates 10 ng/ml 10 ng/ml codeine,morphine,6AM hydrocodone, hydromorphone dihydrocodeine Oxycodone 10 ng/ml 10 ng/ml Phencyclidine 8 ng/ml 8 ng/ml Propoxyphene 50 ng/ml 50 ng/ml THC (marijuana) MTB 5 ng/ml 2 ng/ml
 
Total Drug Classes Includes:  26
Total Drug Metabolites Included:  180
 
Specimen Validity Testing:  Creatinine with normalized drug concentration
 

Risk Calculation:

Each analyte level is converted into a multiple of the GA specific median (MoM) and is then adjusted based on the patient's race, weight, diabetic status, and smoking status.  The likelihood ratio for each analyte is calculated as the ratio of the probability density function in affected pregnancies divided by the probability density function for unaffected pregnancies.  Patient specific risks for Down syndrome and trisomy18/13 are calculated using Bayes’ rule. The prior risk, based on demographic factors, is multiplied by the likelihood ratios for each maker appropriate for the condition screened.

An interpretive risk report including the patient's analyte levels, cut-off values and risks for trisomy 21 and trisomies 18/13 will be provided.

Down’s Syndrome (trisomy 21) Interpretation:

The risk cut-off is set equal to the first-trimester risk of a 35 year old (1/250).  This test may detect 98% of cases with Down’s syndrome at an approximate 2% false positive rate.

Edward Syndrome (trisomy 18)/Patau Syndrome (trisomy 13) Interpretation:

The risk cut-off is set equal to 1/100. This cut-off is chosen to balance the detection and false positive rates.  This test may detect 95% of cases with T18/13 at an approximate 0.5% false positive rate.

Test Follow Up:

If the patient's risk is less than the cut-off risk the test is considered "Within Normal Range" and no further action is required. If the patient’s risk is greater than or equal to the cut-off risk the test is considered "Increased Risk". Patients at increased risk are offered detailed ultrasound, NIPT and/or diagnostic amniocentesis.

Upon receiving maternal serum screening results, all information used in the risk calculation should be reviewed for accuracy (ie, weight, diabetic status, gestational dating). If any information is incorrect, the laboratory should be contacted for recalculation of the estimated risks. ‘Within Range’ risk results typically do not warrant further evaluation. Ultrasound is recommended to confirm dates for ‘Increased Risk’ results. If ultrasound yields new dates that differ by at least 7 days, a recalculation should be considered. The screen results are dependent on accurate information for gestation, race, IDD, and weight. Inaccurate information can lead to significant alterations in the estimated risk. In particular, erroneous assessment of gestational age can result in false-positive or false-negative screen results. Because of its increased accuracy, the determination of gestational age by ultrasound is recommended, when possible, rather than by last menstrual period.

Disclaimers

This is a screening test, not a diagnostic test. A ‘Within Range’ risk result indicates low risk for the conditions screened but does not guarantee the absence of those conditions or other abnormalities. An ‘Increased Risk’ result indicates an increased risk for the condition screened but does not infer a definitive diagnosis.

Cautions

Valid measurements of maternal serum markers cannot be made after CVS or amniocentesis. Triplet and higher order multiple pregnancies cannot be interpreted. In rare cases, some individuals can develop antibodies to mouse or other animal antibodies (often referred to as human anti-mouse antibodies [HAMA] or heterophile antibodies), which may cause interference in some immunoassays. Caution should be used in interpretation of results and the laboratory should be alerted if the result does not correlate with the clinical presentation.

Each center offering maternal serum screening to patients should establish a standard screening protocol, which provides pre- and post-screening education and appropriate follow-up for ‘Increased Risk’ results.

Clinical References

1.   ACOG Practice Bulletin 226 - Screening for Fetal Chromosomal Abnormalities.  Obstet Gynecol VOL. 136, NO. 4, OCTOBER 2020.

2.   NJ Wald, C Rodeck, AK Hackshaw, J Walters, L Chitty, AM Mackinson.  First and second trimester antenatal screening for Down’s syndrome:  the results of the Serum, Urine and Ultrasound Screening Study (SURUSS). (2003) Health Technology Assessment Vol. 7: No.11.

3.   Fergal D. Malone, M.D., Jacob A. Canick, Ph.D., Robert H. Ball, M.D., David A. Nyberg, M.D., Christine H. Comstock, M.D., Radek Bukowski, M.D., Richard L. Berkowitz, M.D., Susan J. Gross, M.D., Lorraine Dugoff, M.D., Sabrina D. Craigo, M.D., Ilan E. Timor-Tritsch, M.D., Stephen R. Carr, M.D., Honor M. Wolfe, M.D., Kimberly Dukes, Ph.D., Diana W. Bianchi, M.D., Alicja R. Rudnicka, Ph.D., Allan K. Hackshaw, M.Sc., Geralyn Lambert-Messerlian, Ph.D., Nicholas J. Wald, F.R.C.P., and Mary E. D’Alton, M.D., for the First- and Second-Trimester Evaluation of Risk (FASTER) Research Consortium* (2005) First-Trimester or Second-Trimester Screening, or Both, for Down’s Syndrome.  N Engl J Med 353;19 2001-2011.

4. Carmichael JB, Liu HP, Janik D, Hallahan TW, Nicolaides KH and Krantz DA.  Expanded conventional first trimester screening.  Prenatal Diagnosis 2017, 37, 802–807.

This test was developed, and its performance characteristics determined by Northwell Health Laboratories. It has not been cleared or approved by the Food and Drug Administration. The methods and performance characteristics have been reviewed and approved by the New York State Department of Health

Not Detected

The FDA-cleared nucleic acid amplification test (NAAT) is intended for in vitro qualitative detection of CMV DNA from saliva swabs from neonates younger than 21 days of age. Positive results from saliva are presumptive and should be confirmed with urine. This assay has been verified at Northwell Health Labs. Results should be interpreted in conjunction with the results of other clinical findings as an aid in the diagnosis of congenital CMV infection.

50-150 mg/24 hours

No Legionella species isolated

<0.2 ng/mL

Environmental exposure: 0-9 µg/L
Dialysis patients: <40 µg/L
Potentially toxic: >60 µg/L

No acid-fast bacilli isolated

No established reference values

See Report
 
TAT: 4-8 Days

Pediatric: see table.¹
• Adults:
− Male: 0−62 nM BCE/mmol creatinine
− Female: 20 to 49 years 0−64 nM BCE/mmol creatinine; >49 years 0−89 nM BCE/mmol creatinine

 Pediatric: see table.¹

• Adults:

− Male: 0−62 nM BCE/mmol creatinine

− Female: 20 to 49 years 0−64 nM BCE/mmol creatinine; >49 years 0−89 nM BCE/mmol creatinine

See report.   TAT 4 - 7 Days
  Units: umol/L
Includes:
C2  ,C3,  C3-Dicarboylic,  C4, C4-Hydroxy, C4-Dicarboxylic, C5, C5:1, c5-Hydroxy, C5-Dicarboxylic, C6, C8,  C10, C10:1, C10:2, C12, C14,  C14:1, C14:2 ,C14-Hydroxy,   C16, C16:1, C16:1-Hydroxy, C16-Hydroxy, C18, C18:1, C18:2, C18-Hydroxy, C18:1-Hydroxy, C18:2-Hydroxy  

Limitations
False-negative results can occur with acylcarnitine profiling, especially when the patient is carnitine deficient, is affected with a milder variant of a disorder, or when clinical condition or dietary supplementation causes secondary changes to the profile. Results of acylcarnitine profiling should be interpreted in the context of clinical presentation as well as other laboratory tests, which may include urine organic acid analysis and molecular testing.
This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA).       
            

Assay Range: 72 copies/mL to 1.00E+08 copies/mL

The limit of quantitation (LOQ) is 72 copies/mL. JC virus DNA

detected below the LOQ will be reported as Detected:<72 copies/mL.

This test was developed and its performance characteristics

determined by Viracor Eurofins. It has not been cleared or approved

by the U.S. Food and Drug Administration. Results should be used in

conjunction with clinical findings, and should not form the sole

basis for a diagnosis or treatment decision.

Risk Calculation:

Each analyte level is converted into a multiple of the GA specific median (MoM) and is then adjusted based on the patient's race, weight, diabetic status, and smoking status. 

The likelihood ratio for each analyte is calculated as the ratio of the probability density function in affected pregnancies divided by the probability density function for unaffected

pregnancies.  Patient specific risks for Down syndrome, trisomy18 and Open Spina bifida are calculated using Bayes’ rule. The prior risk, based on demographic factors, is multiplied

by the likelihood ratios for each maker appropriate for the condition screened.

An interpretive risk report including the patient's analyte levels, cut-off values and risks for trisomy 21, trisomy 18 and open spina bifida will be provided.

Down’s Syndrome (trisomy 21) Interpretation:

The risk cut-off is set equal to that of the mid-trimester risk of a 35 year old (1/270).  If the patient's risk is less than the cut-off risk the test is considered "Within Normal Range".

If the patient’s risk is greater than or equal to the cut-off risk the test is considered "Increased Risk". Patients at increased risk are offered detailed ultrasound, NIPS and/or

diagnostic amniocentesis.  This test may detect 81% of cases with Down’s syndrome at an approximate 5% false positive rate

Edwards Syndrome (trisomy 18) Interpretation:

The risk cut-off is set equal to 1/150. This cut-off is chosen to balance the detection and false positive rates.   If the patient's risk is less than the cut-off risk the test is considered

"Within Normal Range". If the patient’s risk is greater than or equal to the cut-off risk the test is considered "Increased Risk". Patients at increased risk are offered detailed ultrasound,

NIPT and/or diagnostic amniocentesis.  This test may detect 75% of cases with Edwards syndrome at an approximate 0.3% false positive rate

ONTD Interpretation:

ONTD interpretation is based solely on the AFP MoM.  The baseline AFP MoM cut-off is 2.5 MoM. The patient specific cut-off varies based on various risk factors (i.e. Black – 2.80,

IDDM – 1.95, Black and IDDM – 2.21, Twins – 5.0). If the patient's MoM is less than the cut-off the test is considered "Within Normal Range". If the patient’s MoM is greater than or

equal to the cut-off the test is considered "Increased Risk". Patients at increased risk are offered detailed ultrasound and diagnostic amniocentesis (including amniotic fluid AFP and

acetylcholinesterase measurements for NTD. Approximately 80% of pregnancies affected with an ONTD have elevated AFP MoM values.

Test Follow Up: Upon receiving maternal serum screening results, all information used in the risk calculation should be reviewed for accuracy (ie, weight, diabetic status, gestational dating).

If any information is incorrect, the laboratory should be contacted for recalculation of the estimated risks. ‘Within Range’ risk results typically do not warrant further evaluation.

Ultrasound is recommended to confirm dates for ‘Increased Risk’ results. If ultrasound yields new dates that differ by at least 7 days, a recalculation should be considered. The screen results

are dependent on accurate information for gestation, race, IDD, and weight. Inaccurate information can lead to significant alterations in the estimated risk. In particular, erroneous assessment

of gestational age can result in false-positive or false-negative screen results. Because of its increased accuracy, the determination of gestational age by ultrasound is recommended, when

possible, rather than by last menstrual period.

Disclaimers

This is a screening test, not a diagnostic test. A ‘Within Range’ risk result indicates low risk for the conditions screened but does not guarantee the absence of those conditions or other abnormalities.

An ‘Increased Risk’ result indicates an increased risk for the condition screened but does not infer a definitive diagnosis.

Cautions

Valid measurements of maternal serum markers cannot be made after amniocentesis. Triplet and higher order multiple pregnancies cannot be interpreted. In rare cases, some individuals can develop

antibodies to mouse or other animal antibodies (often referred to as human anti-mouse antibodies [HAMA] or heterophile antibodies), which may cause interference in some immunoassays.

Caution should be used in interpretation of results and the laboratory should be alerted if the result does not correlate with the clinical presentation.

Each center offering maternal serum screening to patients should establish a standard screening protocol, which provides pre- and post-screening education and appropriate follow-up

for ‘Increased Risk’ results.

Clinical References

1.ACOG Practice Bulletin 226 - Screening for Fetal Chromosomal Abnormalities.  Obstet Gynecol VOL. 136, NO. 4, OCTOBER 2020.

2.NJ Wald, C Rodeck, AK Hackshaw, J Walters, L Chitty, AM Mackinson.  First and second trimester antenatal screening for Down’s syndrome:  the results of the Serum,

Urine and Ultrasound Screening Study (SURUSS). (2003) Health Technology Assessment Vol. 7: No. 11.

3. Fergal D. Malone, M.D., Jacob A. Canick, Ph.D., Robert H. Ball, M.D., David A. Nyberg, M.D., Christine H. Comstock, M.D., Radek Bukowski, M.D., Richard L.

Berkowitz, M.D., Susan J. Gross, M.D., Lorraine Dugoff, M.D., Sabrina D. Craigo, M.D., Ilan E. Timor-Tritsch, M.D., Stephen R. Carr, M.D., Honor M. Wolfe, M.D.,  Kimberly Dukes, Ph.D.,

Diana W. Bianchi, M.D., Alicja R. Rudnicka, Ph.D., Allan K. Hackshaw, M.Sc., Geralyn Lambert-Messerlian, Ph.D., Nicholas J. Wald, F.R.C.P., and Mary E. D’Alton, M.D., for the First- and

Second-Trimester Evaluation of Risk (FASTER) Research Consortium* (2005) First-Trimester or Second-Trimester Screening, or  Both, for Down’s Syndrome.  N Engl J Med 353;19 2001-2011.

4.Benn PA, Ying J, Beazoglou T and Egan JFX.  Estimates for the sensitivity and false-positive rates for second trimester serum screening for Down syndrome and trisomy 18  with

adjustment for cross-identification and double-positive results.  Prenat Diagn 2001;21: 46-51.

No established reference values

0 - 29.9 mg/24 hours

152 IU/mL to 2.51E+09 IU/mL

An interpretive report will be provided. 

Epinephrine:
0-9 years:0-11 µg/24hours
10 - 19 years: 0-18 µg/24 hours
>19 years:  0-20 µg/24 hrs
 
Norepinephrine:
0-9 years: 0-59 µg/24 hours
10-19 years: 9-90 µg/24 hours
>19 years: 0-135 µg.24 hours
 
Dopamines;
0-9 years: 0-414 µg/24 hours
10-19 years:  0-575 µg/24 hours
> 19 years: 0-510 µg/24 hours 

No parasites observed

Environmental exposure: 3−35 μg/24 hours; <50 μg/g creatinine¹
 
TAT: 3 - 5 Days

0.0-4.7 pg/mL

TAT: 7 - 13 Days

2-10 years: 8.0 mg/24 hr or less
>10 years: 6.0 mg/24 hr or less
 
Limitations: Patients with renal disease may display falsely decreased results. Urinary 5-HIAA is increased in patients with malabsorption disorders who also display a larger concentration of urinary tryptophan metabolites. Urinary 5-HIAA is increased in patients with intestinal obstruction and with some noncarcinoid islet cell tumors. Carcinoid syndrome may not cause elevated results, especially if the patient does not have diarrhea. Requires accurate 24-hour urine collection.

See report
 
Includes: Diazepan, desmethydiazepam, oxazepam,

temazepam, alprazolam, alpha-hydroxyalprazolam,

desalkylflurazepam, lorazepam, alpha-hydroxytriazolam,

cloazepam, 7-aminoclonazepam, and midazolam

Negative

The assay is traceable to the 1st WHO International Standard for BK Virus Nucleic Acid Amplification Techniques (NAT)-based assays.LimitationsThe linear range of the assay is 200-100,000,000 IU/mL. The analytical sensitivity is 12.2 IU/mL.

 Pancreatic amylase:

• Total amylase:

• Salivary amylase:

See report.

No Growth or <10,000 CFU/mL normal urogenital flora

See report.

320−1240 mg/24 hours

Not detected

This test has not been validated for use from patients older than 21 days of age.

No growth 

N-METHYLHISTAMINE

0-5 years: 120-510 mcg/g creatinine

6-16 years: 70-330 mcg/g creatinine

>16 years: 30-200 mcg/g creatinine

    CREATININE

Males: 930-2955 mg/24 hours

Females: 603-1783 mg/24 hours

Reference values have not been established for patients who are younger than 18 years of age.