No acid-fast bacilli isolated

If culture is positive, additional charge(s)/CPT code(s) may apply for identificatio and/or antibiotic susceptibilities performed when appropriate.

No fungus isolated

If culture is positive, additional charge(s)/CPT code(s) may apply for identification and/or antibiotic susceptibilities performed when appropriate.

No growth 

No growth after 6 weeks

If the culture is positive, additional charge(s)/CPT code(s) may apply for identification and/or antibiotic susceptibilities performed when appropriate.

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

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 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 (Both first and second trimester), 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 the mid-trimester risk of a 35 year old (1/270).  This test may detect 95% of cases with Down’s syndrome at an approximate 4.2% false positive rate. (Baer et.al.)

    Edward Syndrome (trisomy 18) 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 93.5% of cases with T18 at an approximate 0.5% false positive rate. (Baer et.al.)

     Open Spina Bifida Interpretation:

The MS-AFP 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 ONTD cut-off is 2.5 MoM but is adjusted to account for the patient’s prior risk factors such as African America/Caribbean race, IDDM, twin pregnancy, family history and use of valproic acid or Carbamazepine. The interpretation is based on the patient's analyte adjusted.

AFP MoM result compared to the risk adjusted cut-off.   For more detail see 2T Maternal Serum AFP (MSAFP)

  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. 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.

   Disclaimers

This test was developed, and its performance characteristics determined by Northwell Health Laboratories. The test has not been cleared or approved by the U.S. Food and Drug Administration. These results do not eliminate the possibility that the pregnancy may be associated with birth defects including open spina bifida, Down syndrome, trisomy 18, trisomy 13 or other disorders not detectable by this screening test. Gestational Age is determined based on first trimester gestational age and number of days between first and second trimester blood collection dates.

   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.

See report.

Reference Range: No Growth

Adult Male

Adult Female

Pediatric Male

Pediatric Female

0.10 – 2.20 ng/mL

Limitations
Overnight (12-hour) patient fasting is required. Consumption of supplements or
food with Vitamin K may elevate plasma concentrations of Vitamin K1 for testing.
Although lipemia does not interfere with the analytical measurement of Vitamin K1
by this test, Vitamin K1 levels are correlated with lipoprotein concentrations. As such,
all lipemic samples should be rejected given Vitamin K1 levels are expected to be
elevated in lipemic specimens1,2 and prevent evaluation for Vitamin K1 insufficiency.

This test was developed and its performance characteristics determined by LabCorp
It has not been cleared or approved by the Food and Drug Administration.

Viability of lymphocytes at day 0: ≥75.0%

Maximum proliferation of phytohemagglutinin as % CD45:
≥49.9%

Maximum proliferation of phytohemagglutinin as % CD3:
≥58.5%

Maximum proliferation of pokeweed mitogen as % CD45:
≥4.5%

See Report

See Report

See Report

Pathologists interpretation

No mutation detected

The assay will not consistently detect germline mosaicism below 50% or rule out the presence of large chromosomal aberrations, including rearrangements, inversions that do not change copy number of genomic regions. The assay does not detect repeat expansions. Possible intergenic variant interactions are not commented on. False positive or false negative results may occur for reasons that include: insufficient information available about rare genetic variants, sex chromosome abnormalities, pseudogene interference, blood transfusions, bone marrow transplantation, somatic or tissue-specific mosaicism, mislabeled samples, or erroneous representation of family relationships. Variants that do not alter an amino acid composition of a protein may be difficult to assess for pathogenicity since they may produce abnormalities in structures not assessed by conventional analysis paradigms, eg, mRNA expression and processing.1 Interpretation of the clinical significance of gene variations is limited by information about the variant that is available at the time of reporting, and by the quality and quantity of clinical information provided with the sample. As the understanding of human genetic diversity improves, the interpretation of the clinical significance of variants may change.
This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration