MON-122 - A Novel Test Method to Improve Ovarian Reserve Assessment using One Blood Drop

Relevance: At-home blood collection, such as the dried blood spots for fertility workups, has been challenging due to low Anti-Mullerian Hormone (AMH) concentrations, the cost of testing, and dependence on trained personnel for reliable blood sample collection. However, recent advancements in the volumetrically accurate microsampling (VAMS) device, which allows for continuous absorption of blood from the tip of a finger, coupled with highly efficient extraction techniques, have renewed the interest in low-volume blood collection. AMH is a hormone produced by small-growing antral follicles (AFC) in the ovary and provides a snapshot of a woman’s reproductive potential.

Objective: This study aimed to develop and validate an AMH blood test using the VAMS device. The analytical characteristics: method comparison, hematocrit interference, linearity of dilution, imprecision, sample stability, and clinical comparison of AMH to antral follicle count were established.

Materials and

Methods: Matched VAMS, plasma, and DBS specimens from 25 patients (ages 18-45 years) were collected on day 3 of the cycle. The subjects were visiting the clinic for initial fertility workup; subjects on medications for ovarian suppression were excluded. The specimens were tested in Ansh Labs DBS AMH(AL-129) and picoAMH (AL-124-r). Baseline AFC was obtained using transvaginal ultrasound. Spearman’s correlations and Passing and Bablok analysis were used to examine the relationship between AFC and AMH measurements.

Results: The VAMS AMH method highly correlates with the plasma and DBS AMH ELISA. The slope and Spearman’s rank correlation(rs) between AMH methods for VAMS, plasma, and DBS were 0.66x, 0.66x, and 0.99, 0.97, respectively. VAMS AMH measurements were highly correlated to AFC (rs=0.813). AMH measurements using VAMS were highly reproducible( < 8%CV), accurate, with no cross-reactivity to FSH, LH, Inhibin B, and Estradiol. No significant hematocrit interference was observed. The VAMS samples dilute linearly(y=0.98x). The high AMH test result (≥8 ng/mL) was consistent with PCOS, and a low AMH test result (≤0.66ng/mL) was consistent with primary ovarian insufficiency subjects.

Conclusions: A new AMH test method has been established using VAMS as a sample collection method. This test method can facilitate decentralized blood collection in remote locations, revolutionizing the future of sample collection and ovarian reserve testing for all reproductive-age women.

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