Table 1.
Variable | CLIA laboratory n = 86 658a | Futch et al.10 n = 6123b |
---|---|---|
Maternal age (years) | ||
n | 85 200 | 6123 |
Mean ± SD | 35.3 + 5.1 | 35.0 ± 5.7 |
Min–max | 13.8–57.8c | 14.6–51.7 |
Gestational age (weeks) | ||
n | 85 144 | 6123 |
Mean ± SD | 14.0 ± 4.2 | 15.6 ± 4.6 |
Min–max | 4d–38 | 5d–37 |
Gestational age group, n (%)e | ||
n | 85 144 | 6123 |
First (10–13.9 weeks) | 54 088 (63.5) | 2883 (47.2) |
Second (14–27.9 weeks) | 29 963 (35.2) | 3103 (50.8) |
Third (28–40+ weeks) | 1093 (1.3) | 127 (2.1) |
Turnaround time (business days) | ||
Mean | 3.3 | 5.1 |
Interquartile range | 2–4 | 4–6 |
Total cancelations, n (%) | 1376 (1.6) | 149 (2.4) |
Technicalf | 101 (0.1) | 43 (0.7) |
Administrativeg | 1214 (1.4) | 106 (1.7) |
Site‐specifich | 45 (0.05) |
CLIA, Clinical Laboratory Improvement Amendments.
Not all samples reported all demographic variables; thus, counts are reported separately.
Data from Futch T., Spinosa J., Bhatt S., De Feo E., Rava R.P., and Sehnert A.J. Initial clinical laboratory experience in noninvasive prenatal testing for fetal aneuploidy from maternal plasma DNA samples. Prenat Diagn 2013; 33:569‐74.
Maternal age was confirmed in both low and high extremes; the maternal age range was similar to other large‐scale clinical studies.12, 21
Samples received from patients under 10 weeks of gestational age were canceled.
Trimester at time of blood draw.
Technical cancelations are samples that did not meet quality control standards; this included high cfDNA (41/101, 58.9%), insufficient cfDNA content (11/101, 7.5%), quality control (QC) failure (43/101, 29.5%), and laboratory processing issue (6/101, 4.1%).
Administrative cancelations did not begin the testing process. Common reasons for administrative cancelations were insufficient sample quantity, tube received beyond stability period (>5 days from draw), test canceled by ordering physician, and gestational age less than 10 weeks.
Cancelations were because of an international site‐specific sample stability issue that has since been resolved.