SpermCheck® Fertility, an immunodiagnostic home test that detects normozoospermia and severe oligozoospermia

Coppola, Michael A.; Klotz, Kenneth L.; Kim, K.-a.; Cho, H.Y.; Kang, Jiaqi; Shetty, Jagathpala; Howards, Stuart S.; Flickinger, Charles J.; Herr, John C.

doi:10.1093/humrep/dep413

Cited by 77 publications

(54 citation statements)

References 30 publications

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“…All a user would need to do is to mix a finger-prick volume of blood with Drabkin’s reagent at the appropriate ratio, and deposit a droplet of this mixture on paper. The complexity of these operations is about the same as that of the sample preparation steps required from consumers for performing at-home rapid diagnostic tests for sperm count (35) or HbA 1C (36)). All subsequent operations of the paper-based Hb assay are completely automated and user-independent, including the scanning and analysis of the stains.…”

Section: Discussionmentioning

confidence: 99%

Simple Paper-Based Test for Measuring Blood Hemoglobin Concentration in Resource-Limited Settings

et al. 2013

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Background The measurement of hemoglobin concentration ([Hb]) is performed routinely as a part of a complete blood cell count to evaluate the oxygen-carrying capacity of blood. Devices currently available to physicians and clinical laboratories for measuring [Hb] are accurate, operate on small samples and provide results rapidly, but may be prohibitively expensive for resource-limited settings. The unavailability of accurate but inexpensive diagnostic tools often precludes proper diagnosis of anemia in low-income developing countries. Therefore, we developed a simple paper-based assay for measuring [Hb]. Methods A 20-μL droplet of a mixture of blood and Drabkin’s reagent was deposited onto patterned chromatography paper. The resulting blood stain was digitized with a portable scanner and analyzed. The mean color intensity of the blood stain was used to quantify [Hb]. We compared the performance of the paper-based Hb assay with a hematology analyzer (comparison method) using blood samples from 54 subjects. Results The values of [Hb] measured using the paper-based assay and the comparison method were highly correlated (R2 = 0.9598); the standard deviation of the difference between the two measurements was 0.62 g/dL. The assay was accurate within 1 g/dL 90.7% of the time, overestimating [Hb] by ≥1 g/dL in 1.9% and underestimating [Hb] by ≥1 g/dL in 7.4% of the subjects. Conclusions This study demonstrates the feasibility of the paper-based Hb assay. This simple, low-cost test should be useful for diagnosing anemia in resource-limited settings, particularly in the context of care for malaria, HIV and sickle cell disease patients in sub-Saharan Africa.

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Section: Discussionmentioning

confidence: 99%

Simple Paper-Based Test for Measuring Blood Hemoglobin Concentration in Resource-Limited Settings

et al. 2013

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“…The home pregnancy test is the most widely used fertility-based diagnostic, enabling women to perform self-testing at their own discretion. Lateral flow assays have also been developed for home semen analysis; for example, SpermCheck (ContraVac) and FertilMARQ (Wisconsin Pharmacal) use colorimetric signals to semiquantitatively determine total sperm concentration within a sample (i.e., whether sperm concentration is Ͼ20 million/mL) (33,34 ). Additionally, the Fertell assay (Genosis) measures motile sperm count by allowing sperm to swim up a fluid-filled reservoir toward a nitrocellulosebased immobilization region (35 ).…”

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confidence: 99%

Paper-Based Quantification of Male Fertility Potential

et al. 2016

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BACKGROUND:More than 70 million couples worldwide are affected by infertility, with male-factor infertility accounting for about half of the cases. Semen analysis is critical for determining male fertility potential, but conventional testing is costly and complex. Here, we demonstrate a paper-based microfluidic approach to quantify male fertility potential, simultaneously measuring 3 critical semen parameters in 10 min: live and motile sperm concentrations and sperm motility.

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“…Such methods are already FDA approved and currently many couples confirm near azoospermia post-vasectomy before ceasing other contraceptive methods 58 . These techniques can be used to assess male infertility 59 and even more sensitive fluorescent methods are being developed for home use 60 .…”

Section: 4 Alternative Approachesmentioning

confidence: 99%

Male hormonal contraception: hope and promise

Piotrowska

Wang

Swerdloff

et al. 2017

The Lancet Diabetes & Endocrinology

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Family planning is a shared responsibility, but currently available male-directed methods are either not easily reversible (vasectomy) or not sufficiently effective (condom). Despite this, approximately 20% of couples using a contraceptive method worldwide, and up to 80% in some countries, choose a male-directed method. Male hormonal contraception (MHC) is acceptable and highly effective, with perfect use failure rates of 0.6% (95% confidence interval 0.3–1.1%) provided sperm concentration are maintained below 1 M/mL. Upon cessation of MHC, sperm quality fully recovers in a predictable manner resulting in pregnancies and live births. Spontaneous miscarriage and fetal malformation rates overlap that observed in the general population. Short-term adverse events, namely acne, night sweats, increased weight and altered mood and libido are recognized, but are generally mild. Further optimization of specific androgen-progestin regimens followed by Phase 3 studies of lead combinations is still required for successful development of an approved MHC and to determine long term adverse effects.

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SpermCheck® Fertility, an immunodiagnostic home test that detects normozoospermia and severe oligozoospermia

Cited by 77 publications

References 30 publications

Simple Paper-Based Test for Measuring Blood Hemoglobin Concentration in Resource-Limited Settings

Simple Paper-Based Test for Measuring Blood Hemoglobin Concentration in Resource-Limited Settings

Paper-Based Quantification of Male Fertility Potential

Male hormonal contraception: hope and promise

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