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Comparative Assessment of Serum versus Menstrual Blood for Diagnostic Purposes: A Pilot Study

Sci Forschen
Open HUB for Sc i e n t if i c R e s e a r c h
Journal of Clinical and Laboratory Medicine
ISSN 2572-9578 | Open Access
J Clin Lab Med | JCLM
Comparave Assessment of Serum versus Menstrual Blood for Diagnosc
Purposes: A Pilot Study
Sara Naseri, Klaira Lerma, and Paul D Blumenthal*
Department of Obstetrics and Gynecology, School of Medicine, Stanford University, CA, USA
Received: 03 Oct, 2019 | Accepted: 13 Nov, 2019 | Published: 20 Nov, 2019
Volume 4 - Issue 2
*Corresponding author: Paul Blumenthal, Pasteur Drive, Stanford, USA, Tel: 650-721-1562; E-mail:
Citaon: Naseri S, Lerma K, Blumenthal PD (2019) Comparave Assessment of Serum versus Menstrual Blood for Diagnosc Purposes: A
Pilot Study. J Clin Lab Med 4(2):
Copyright: © 2019 Naseri S, et al. This is an open-access arcle distributed under the terms of the Creave Commons Aribuon License,
which permits unrestricted use, distribuon, and reproducon in any medium, provided the original author and source are credited.
Background: Blood testing remains an essential component of diagnosis and prevention of disease. Phlebotomists, Laboratory Infrastructure,
Storage, Collection, and Transport are required for Current Methods of Blood Collection. Menstrual Blood has many similar characteristics
to circulating blood but has not previously been assessed as a Potential Diagnostic Resource.
Objective: To assess if biomarkers derived from menstrual blood correlate with systemic blood.
Study design: This was a prospective, observational pilot study of healthy reproductive-aged women. We chose a panel of 9 Biomarkers,
used in preventative health assessments and for following clinical conditions, and compared systemic and menstrual blood levels.
Results: Eighty-Four volunteers were screened over two months; 35 provided a menstrual and serum sample, of which 20 had a sample
adequate for analysis. Overall, the correlation was observed, particularly for 7 Biomarkers, with no statistically significant differences
between the mean menstrual and serum values. These include cholesterol (P for differences in means=0.89, R2 for correlation=0.89),
Creatinine (P=0.32, R2=0.94), HSCRP (P=0.89, R2=0.99), LDL (P=0.21, R2=0.84), Triglycerides (P=0.45, R2=0.89), Hba1c (P=0.54, R2=0.80),
and HDL (P=0.33, R2=0.77). One biomarker, FSH (P<0.001, R2=0.97), was less directly comparable to systemic blood, but a linear relationship
was recognized suggesting that the correlation could be mathematically derived, and therefore diagnostic utility is possible.
Conclusion: Based on our results, menstrual blood can reliably estimate levels of several biomarkers and may be a promising option for non-
invasive collection of blood for diagnosis and health monitoring. Larger trials are needed to confirm these findings.
of disorders were present in menstrual uid [1]. ese disorders
include endometriosis, breast, Cervical, Ovarian and Endometrial
Cancer. Several other studies have detected the presence of Human
Papilloma Virus (HPV) in menstrual blood implying that it may be
useful for non-invasive screening for cervical cancer or pre-cancer
[2,3]. Furthermore, menstrual blood has been studied for screening
or diagnosis of Sexually Transmitted Infections (STIS). Alary M, et
al. explored the potential of using vaginal uid collected in menstrual
pads for Chlamydia detection. is proved to have sensitivity and
specicity equivalent to, or even higher than, existing methods,
including vaginal swabs or urine samples [4]. ese data combine
to provide support for the potential utility of menstrual blood-based
testing as a non-invasive alternative blood source for diagnostic or
therapeutic analysis.
Despite this apparent potential, menstrual blood remains a
relatively uninvestigated area for diagnostics; no published literature
explores the correlation of systemic versus menstrual-based blood
for assessing biomarkers relative to indicators of health or disease.
Whole blood or Serum (Systemic Blood) is commonly used to
diagnose or monitor many medical conditions. However, obtaining
a specimen is an invasive procedure, requiring medical assistance.
It can be inconvenient, costly, painful, and anxiety-provoking. Most
reproductive-aged women menstruate regularly, and while menstrual
blood shares many characteristics with systemic blood, it has not
been subject to rigorous clinical investigations for diagnostic and
therapeutic purposes.
Menstrual blood is composed of three distinct body uids: whole
blood, vaginal uid, and the cells and uid of the late Secretory Phase
of the endometrial lining and the cervix, shed during menstruation.
Molecular proteomic studies have shown considerable correlation
with systemic blood; however, menstrual blood also contains
additional uids [1]. Specically, at least 385 additional proteins
can be detected in menstrual blood when compared with systemic
blood [1]. In 2012 Siegel D, et al. rst dened the proteomics of
menstrual blood, and found that several biomarkers for a wide range
Sci Forschen
Open HUB for Sc ie n t i f i c R e s e a r c h
Citaon: Naseri S, Lerma K, Blumenthal PD (2019) Comparave Assessment of Serum versus Menstrual Blood for Diagnosc Purposes:
A Pilot Study. J Clin Lab Med 4(2): 2
Journal of Clinical and Laboratory Medicine
Open Access Journal
To assess this, we conducted a proof-of-concept study, comparing
menstrual blood to systemic blood. We hypothesized that if menstrual
blood biomarkers correlated with systemic blood, this alternative
testing method could have potential as a convenient, non-invasive
and cost-eective approach to blood analysis for both diagnosis
and therapeutics. If found reliable, such an approach could enhance
opportunities for early disease detection and regular health monitoring
among women who menstruate.
Materials and Methods
is was a prospective, observational, pilot study of healthy
reproductive-aged women. Interested women completed a telephone
screening to assess eligibility and willingness to participate. Exclusion
criteria included being younger than 18 years of age, older than 45
years, postmenopausal, not menstruating regularly, and uncomfortable
with or clinically unable to use a menstrual cup for menstrual blood
ose who were eligible per telephone screening were invited to
an in-person meeting. During the meeting the study processes were
explained in detail and instructions of how to use a menstrual cup were
given to ensure participants were aware and comfortable using it for the
menstrual blood collection. Demographic and other information such
as age, weight, birth control usage, expected dates for menstruation,
and health issues and concerns, were collected. All participants signed
consent forms and were given a study kit containing a menstrual cup
and two blood collection tubes. e menstrual cup (diva international
inc., on, Canada) used for menstrual blood collection is a exible
menstrual cup that is worn internally, around the cervix to collect,
rather than absorb, menstrual ow. It is hypo-allergenic, latex-free
and safe when used as directed. e materials used in the study are
commonly used and are FDA, CE or who-prequalied. e study was
approved by the Stanford Institutional Review Board (IRB-35817).
Participants were instructed to contact study sta on the rst day of
their period, being the rst day with actual ow. at day, participants
were instructed to stop intake of food aer midnight. On the second
day of their period participants were instructed to use the menstrual
cup for three hours, starting at the time they woke up in the morning,
and then immediately pour the collected menstrual blood into the
designated blood collection tubes. e second day was chosen due
to convenience and because the second day of menstruation for
most participants was found to be the day with the heaviest ow of
menstrual blood. When participants presented at the study site-a
venous blood draw was performed, and the menstrual blood samples
were collected. e venous samples were collected on the same day as
the menstrual blood samples. Neither the participants nor study sta
observed any clotting in the menstrual blood samples. Both blood
samples were pipetted onto Dried Blood-Spot (DBS) blood collection
cards (advance DX inc., AZ, USA). DBS is considered interchangeable
with venepuncture [5,6] and was used as a convenient and cost-
eective way to transport blood samples to the laboratory for analysis.
Because both samples were collected on DBS and both samples were
analyzed with same methods and by the same laboratory, any eect
on the samples using DBS would be applicable to both samples and
therefore the comparison of the two samples is valid. A total of four
cards per sample type were utilized. e eight blood collection cards
per participant were shipped on the same day to a CLIA/CAP Certied
Laboratory and DBS specialist, us specialty (San Diego, CA, USA),
where the coded samples were analyzed. All samples were provided to
the lab with no indication as to the source (i.e., menstrual or serum), so
that analyses were performed in a “blinded” fashion. All participants
were compensated for their travel and time spent in clinic.
Results were analyzed using paired t-tests to compare mean
values of systemic blood to menstrual blood; condence intervals
were calculated to provide insight into the magnitude of the mean
dierences. Further, via correlation analysis of the paired samples,
we analyzed whether it is possible to predict systemic blood results
based on menstrual blood results. We used the method of least squares
to create the trend line. Such a calculation would mean that systemic
blood values are not necessarily identical to menstrual blood results,
but that correlations could be mathematically predicted, indicating that
certain systemic blood biomarkers can be estimated from menstrual
blood. To assess the strength of the linear relationship we used Pearson
correlation coecient, which varies from -1 (perfect linear negative
relationship) to +1 (perfect linear positive relationship) with values
around 0 corresponding to weak relationship.
Between March 2016 and March 2017, 145 volunteers were evaluated
for participation, and pre-procedure meetings were arranged for 84
eligible women, who represented a convenience sample. We enrolled
and collected menstrual and systemic blood from 35 participants.
For 15 participants, the volume of menstrual blood collected was
insucient for analysis and those participants were excluded, leaving
20 participants in this analysis. Our participants were young and
healthy, and the majority reported regular menstrual periods [n=20,
96.2%] (Table 1).
In comparing paired samples of systemic blood to menstrual
blood (n=20), there were no statistically signicant dierences among
values for cholesterol, FSH, HBA1C, and HSCRP. For other markers,
specically Creatinine, glucose, LDL, and triglycerides, the mean
dierence between the pairs was statistically signicantly dierent;
in these analyses several outliers were observed from the trend. In all
cases of statistically signicant dierences between the paired samples,
serum values were higher than menstrual values. Systemic blood
demonstrated much higher levels of glucose compared to menstrual
blood (Table 2).
Systemic blood values were signicantly correlated with their
menstrual blood counterparts (p<0.05), except for glucose (correlation
coecient below 0.2, p>0.05). Regression analysis revealed coecients
that demonstrated a strong linear relationship for multiple analytes
(p<0.05), table 3, including cholesterol (r=0.942, p<0.001), Creatinine
(r=0.973, p<0.001), FSH (r=0.982, p<0.001), HSCRP r=0.996,
p<0.001), and triglycerides (r=0.944, p<0.001). However, there was
Age, mean (± SD) 28 ± 8.7
Race, n (%)
White 14 (70.0)
Asian 4 (20.0)
Other 2 (10.0)
Body Mass Index (BMI), mean (± SD) 21.9 ± 3.3
Regular menstrual cycle, n (%) 25 (96.2)
Hygiene product used regularly, n (%)
Tampons only 6 (30.0)
Pads only 3 (15.0)
Menstrual cup 3 (15.0)
Both tampons and pads 8 (40.0)
Table 1: Parcipant Characteriscs, N=20.
Sci Forschen
Open HUB for Sc ie n t i f i c R e s e a r c h
Citaon: Naseri S, Lerma K, Blumenthal PD (2019) Comparave Assessment of Serum versus Menstrual Blood for Diagnosc Purposes:
A Pilot Study. J Clin Lab Med 4(2): 3
Journal of Clinical and Laboratory Medicine
Open Access Journal
poor correlation between menstrual and systemic blood for glucose
(r=0.195, p=0.411). e correlation analysis showed that although
the FSH was one of the biomarkers for which we observed signicant
dierences in systemic and menstrual blood values, using the derived
equation, it was possible to predict systemic blood FSH (r=0.982)
knowing the result based on menstrual blood. e relationships
between systemic and menstrual blood samples for some of the
biomarkers are illustrated in gure 1.
Our analysis indicates statistically signicant correlation of values
for eight biomarkers in systemic and menstrual blood samples:
cholesterol, Creatinine, HSCRP, LDL, triglycerides, hba1c HDL, and
FSH (Table 1). ese results indicate that biomarkers in menstrual blood
can approximate systemic blood levels and, based on the observations
reported here, menstrual blood could be used to estimate the serum
levels of these 8 biomarkers. When there was a statistically signicant
mean dierence between systemic and menstrual blood (e.g., FSH), it
was possible to generate a formula correlating the systemic blood to
the menstrual blood which resulted in a high correlation coecient.
Of all the analytes tested, there was a much more marked dierence
between serum and menstrual blood for glucose. We hypothesize this
is because the resident ora in the vagina used the glucose for their
own metabolic needs, thus lowering the value relative to serum, where
there are no similar resident bacteria.
While these data are promising, the data presented here is limited
by a small sample size, and the stability and method of collection of
menstrual blood was not optimized, leading to several failed samples.
In addition, when the dierence in paired means was statistically
signicant, the menstrual values were always lower than the serum
values, indicating possible degradation of the analytes in the menstr ual
cup. Also, for those analytes showing statistically signicant dierences
between the means, the dierence appeared to be due to some pairs
showing huge dierences compared to the majority of pairs showing
minor or no dierences. Larger studies will likely provide better results
and reference ranges for these and, possibly, other biomarkers, with
outliers having less eect on the overall analysis.
Another limitation was the use of menstrual cups since 1) some
women declined participation in the study because they were
uncomfortable with this method of collection, and 2) it is possible that
blood sitting in the menstrual cup could become degraded if le too
long before analysis. A dierent device, such as a modied menstrual
pad, could be a more convenient and comfortable method of collection
and could potentially improve both participation rates and the quality
of the specimen for analysis. Future studies using both larger sample
sizes and utilizing an optimized system for collecting menstrual blood
are needed to better establish these reference ranges as well as any
adjustment formulas for relevant biomarkers. Such formulas will allow
approximation of systemic blood results based on menstrual blood
results with an improved degree of accuracy.
Further study is needed to establish many of the reference ranges
and correlation information. We plan to expand the number of women
tested to establish reference ranges and adjustment formulas for each
biomarker and optimize the collection of menstrual blood, using a
specially designed menstrual pad that will yield a dried blood spot for
analysis instead of pooled menstrual blood in a cup.
Despite our limitations, from a preliminary, “proof of concept”,
perspective, these results provide data to support the potential of
using menstrual blood-based testing as an alternative to systemic
blood analysis. Such an alternative testing approach has the potential
to change practice and potentially improve safety, convenience, and
cost eectiveness of blood analysis for both diagnosis and therapeutic
monitoring among menstruating women. e approach could also
enhance opportunities for early detection and regular health monitoring
worldwide especially in rural areas and developing countries where
the population has limited access to medical professionals.
We would like to thank Professor Maecker Holden, PhD,
Stanford University, Cancer Biology, and Yael Rosenberg-Hasson,
Biomarker Systemic Blood Menstrual Blood Mean 95% Condence Interval Of The Dierence
Cholesterol(mg/Dl) 164.86 ± 36.84 163.20 ± 38.53 1.66 -4.38 to 7.70
Creanine (mg/Dl) 1.04 ± 0.75 1.28 ± 0.72 -0.24 -0.32 to -0.16
FSH (Uiu/Ml) 4.99 ± 2.33 4.86 ± 2.49 0.13 -0.09 to 0.35
Glucose (mg/Dl) 90.58 ± 8.63 9.91 ± 10.30 80.67 75.01 to 86.33
Hba1c (%) 5.35 ± 0.36 5.27 ± 0.45 0.08 -0.02 to 0.18
HDL (mg/Dl) 63.10 ± 13.27 59.22 ± 11.29 3.88 0.92 to 6.83
Hscrp (mg/Dl) 4.12 ± 6.02 3.86 ± 6.00 0.26 -0.01 to 0.51
LDL (mg/Dl) 95.79 ± 30.67 83.67 ± 28.91 12.12 6.45 to 17.78
Triglycerides(mg/Dl) 84.40 ± 51.55 71.91 ± 51.12 12.49 4.41 to 20.57
Table 2: Paired Sample Comparison of Systemic and Menstrual Blood Samples, N=20.
FSH: Follicle Smulang Hormone; HbA1c: Hemoglobin A1c; HDL: High-Density Lipoprotein; HSCRP: High Sensivity C Reacve Protein; LDL: Low
Density Lipoprotein.
Pearson’s Correlaon 95% CI P-Value
Cholesterol 0.942 0.86-0.98 <0.001
Creanine 0.972 0.93-0.99 <0.001
FSH 0.982 0.95-0.99 <0.001
Glucose 0.195 0.27-0.59 0.41
Hba1c 0.892 0.74-0.96 <0.001
HDL 0.88 0.71-0.95 <0.001
Hscrp 0.996 0.99-1.00 <0.001
LDL 0.919 0.80-0.97 <0.001
Triglycerides 0.944 0.86-0.98 <0.001
CI: Condence Interval; FSH: Follicle Smulang Hormone; HbA1c: He-
moglobin A1c; HDL: High Density Lipoprotein; HSCRP: High Sensivity C
Reacve Protein; LDL: Low Density Lipoprotein.
Table 3: Pearson Correlaon Coecients between Menstrual and Sys-
temic Blood Samples.
Sci Forschen
Open HUB for Sc ie n t i f i c R e s e a r c h
Citaon: Naseri S, Lerma K, Blumenthal PD (2019) Comparave Assessment of Serum versus Menstrual Blood for Diagnosc Purposes:
A Pilot Study. J Clin Lab Med 4(2): 4
Journal of Clinical and Laboratory Medicine
Open Access Journal
Figure 1: Correlaon between menstrual and serum blood for selected analytes.
Technical Director, Institute for Immunity, Transplantation, and
Infection, for their support in the initial validation phase. We also
acknowledge Joel Zinda at US Specialty Labs for help with sample
analysis, and Megan Fitzpatrick, MD, for careful reading of the
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4. Alary M, Poulin C, Bouchard C, Forer M, Murray G, et al. (2001)
Evaluaon of a Modied Sanitary Napkin as a Sample Self- Collecon
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... It is a complex biological fluid made up of three different types of body fluids: whole blood, vaginal fluid, and uterine wall cells and their secretions [60]. While proteomic studies have revealed that menstrual blood and systemic blood share some protein indicators in common, there is evidence of few biomarkers exclusive to menstrual blood [61]. Multiple proteomic methodologies and analytical methods were used in a study by Yang et al., which resulted in the discovery of 385 proteins, unique to menstrual blood [60]. ...
... Multiple proteomic methodologies and analytical methods were used in a study by Yang et al., which resulted in the discovery of 385 proteins, unique to menstrual blood [60]. This work defined the proteomic composition of menstrual blood for the first time [60,61]. Additionally, this study concluded by emphasizing that menstrual fluid contains protein biomarkers valuable for a variety of illnesses, including cervical, breast, ovarian, and uterine cancers [60]. ...
Full-text available
Cervical cancer is one of the top malignancies in women around the globe, which still holds its place despite being preventable at early stages. Gynecological conditions, even maladies like cervical cancer, still experience scrutiny from society owing to prevalent taboo and invasive screening methods, especially in developing economies. Additionally, current diagnoses lack specificity and sensitivity, which prolong diagnosis until it is too late. Advances in omics-based technologies aid in discovering differential multi-omics profiles between healthy individuals and cancer patients, which could be utilized for the discovery of body fluid-based biomarkers. Body fluids are a promising potential alternative for early disease detection and counteracting the problems of invasiveness while also serving as a pool of potential biomarkers. In this review, we will provide details of the body fluids-based biomarkers that have been reported in cervical cancer. Here, we have presented our perspective on proteomics for global biomarker discovery by addressing several pertinent problems, including the challenges that are confronted in cervical cancer. Further, we also used bioinformatic methods to undertake a meta-analysis of significantly up-regulated biomolecular profiles in CVF from cervical cancer patients. Our analysis deciphered alterations in the biological pathways in CVF such as immune response, glycolytic processes, regulation of cell death, regulation of structural size, protein polymerization disease, and other pathways that can cumulatively contribute to cervical cancer malignancy. We believe, more extensive research on such biomarkers, will speed up the road to early identification and prevention of cervical cancer in the near future.
... Menstrual blood, whether collected by a menstrual cup or a modified menstrual pad, has already been shown to correlate well with a number of commonly used serum tests, such as hemoglobin A 1C and thyroid-stimulating hormone. 10,11 Additionally, dried blood spot is arguably easier to transport than slides, urine, blood from a menstrual cup, or liquid-based cervico-vaginal samples; it requires no refrigeration, is not considered a hazardous material, and can potentially provide a variety of laboratory tests in a self-collected sample. Proteomic and small-scale HPV-detection studies on menstrual blood have been published recently, 12-14 but rigorous, larger scale, and implementation-level studies remain to be performed. ...
Objective: To assess concordance and acceptability of a modified menstrual pad compared with a clinician-collected high-risk human papillomavirus (HPV) sample. Methods: This was a prospective observational study. Women presenting for either cervical cancer screening or with a history of high-risk HPV positivity were eligible. Three samples were requested from participants: 1) clinician-collected cervical specimens; 2) self-collected vaginal swabs; and 3) a modified menstrual pad, which was taken home for use during the next menstruation. All samples were processed using the Cobas HPV test. Menstrual pad dried blood spots were eluted, then similarly processed. Results: Of 153 women enrolled in the study, 106 provided menstrual pad samples and clinician-collected cervical specimens for high-risk HPV analysis. For samples in which the interval between the clinician-collected specimen and the menstrual pad sample was less than 2 months, the concordance was 94% (95% CI 83-98). For women who tested positive for high-risk HPV who presented for general screening and those with more than cervical intraepithelial neoplasia 2, menstrual pad and clinician-collected specimen agreement was 100% (95% CI 32.5-100). Among participants, 22.9% expressed discomfort with the self-collected vaginal swabs and opted out of collection. Overall, 94.0% of participants preferred the menstrual pad over clinician-collected sampling. Twelve patients were found to be positive for HPV on the menstrual pad sample but negative on the clinician-collected specimen. Conclusion: Among women who tested positive for HPV, the menstrual pad showed highly concordant results compared with clinician-collected sampling. This collection approach shows promise for integration into cervical cancer prevention programs.
... Our results expand on and corroborate previous pilot analyses, which demonstrate a concordance between menstrual blood and serum for numerous common biomarkers. 14 Self-sampling has emerged as a viable screening and diagnostic approach across numerous clinical domains. Well-validated applications include saliva for ovulation or DNA testing, 19 20 cervical specimens for human papillomavirus (HPV) testing [21][22][23] and, most recently, nasal swabs for COVID-19 testing. ...
Background Glycated haemoglobin (HbA1c) is the diagnostic and prognostic standard for clinical management of diabetes mellitus (DM). Unfortunately, patient adherence to guidelines for routine testing can be poor and there are significant gender-based disparities in DM management and outcomes. Recent evidence suggests that menstrual blood may be comparable to systemic blood for monitoring of common biomarkers. The objective of the present study was to assess the concordance of HbA1c levels between menstrual and systemic blood in healthy women and women with diabetes of reproductive age. Methods In this prospective, observational cohort study, we enrolled healthy and diabetic (type 1 and type 2 DM) reproductive-age women (aged ≥18 and ≤45 years). Menstrual blood and venous systemic blood specimens were simultaneously obtained at time of menstruation, and analysed for HbA1c levels. Participants self-collected menstrual blood using a QPad, a novel, modified menstrual pad with an embedded dried blood spot strip. Results Among 172 participants, 57.6% were healthy and 42.4% had a diagnosis of either type 1 or type 2 DM. There were no significant differences in mean HbA1c values in menstrual and systemic blood across the overall cohort or within the diabetic subgroup. Furthermore, HbA1c levels between blood sources were robustly correlated and demonstrated a significant linear relationship. Conclusions There is a strong concordance in HbA1c levels between menstrual and systemic blood. Empowered by self-collection technologies, these findings suggest that menstrual blood may serve as a reliable, non-invasive and potentially cost-effective alternative to serum for HbA1c monitoring among reproductive-age women with DM.
Full-text available
Menstruation is the expulsion of the endometrial lining of the uterus following a nearly month long preparation for embryo implantation and pregnancy. Increasingly, the health of the endometrium is being recognized as a critical factor in female fertility, and proteomes and transcriptomes from endometrial biopsies at different stages of the menstrual cycle have been studied for both diagnostic and therapeutic purposes (1-3). Disorders of the uterus ranging from benign to malignant tumors, as well as endometriosis, can cause abnormal menstrual bleeding and are frequently diagnosed through endometrial biopsy (2, 4). Yet the proteome of menstrual blood, an easily available noninvasive source of endometrial tissue, has yet to be examined for possible causes or diagnoses of infertility or endometrial pathology. This study employed five different methods to define the menstrual blood proteome. A total of 1,061 proteins were identified, 361 were found by at least two methods and 678 were identified by at least two peptides. When the menstrual blood proteome was compared to those of circulating blood (1,774 proteins) and vaginal fluid (823 proteins), 385 proteins were found unique to menstrual blood. Gene ontology analysis and evaluation of these specific menstrual blood proteins identified pathways consistent with the processes of the normal endometrial cycle. Several of the proteins unique to menstrual blood suggest that extramedullary uterine hematopoiesis or parenchymal hemoglobin synthesis may be occurring in late endometrial tissue. The establishment of a normal menstrual blood proteome is necessary for the evaluation of its usefulness as a diagnostic tool for infertility and uterine pathologies. Identification of unique menstrual blood proteins should aid the forensic community in distinguishing menstrual blood from circulating blood.
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Hemoglobin A1c (HbA1c) has been endorsed as a tool for the diagnosis of diabetes. This test requires instrumentation that may not be available in underdeveloped areas. Dried blood spot (DBS) samples collected by finger stick procedures offer a mechanism to transport samples to laboratories that do measure HbA1c. Whole blood (ethylenediaminetetraacetic acid) was applied to Ahlstrom 226 filter paper. These DBS samples were compared to whole blood samples using the Roche Tina-quant II immunoturbidometric assay. Hemoglobin A1c stability on DBS was assessed at three temperatures-4, 25, and 40 degrees C-for up to 9 days. A 44-day study was also done for DBS at 20-25 degrees C. The Tina-quant II DBS method showed excellent agreement with whole blood HbA1c results (r(2) = 0.99) with a slight positive mean bias of 0.08 +/- 0.04% HbA1c (95% confidence interval). The variation in HbA1c on DBS samples subjected to different temperatures and times did not exceed 5.6%. Dried blood spot samples represent an alternative to whole blood for HbA1c by measurement when transporting whole blood is not feasible.
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The Papanicolaou test generates pain and embarrassment, and cytology screening has limited sensitivity for detection of cervical neoplasia. These factors urge the use of another screening test that can overcome these limitations. We explore a completely noninvasive method using detection of human papillomavirus (HPV) DNA in women's menstrual blood (MB). The participants were divided into 3 cohorts: (i) 235 patients with cervical intraepithelial neoplasia 3 (CIN 3) (n = 48), CIN 2 (n = 60), CIN 1 (n = 58), or condyloma acuminatum (CAC) (n = 69) before treatment or remission; (ii) from the first cohort of patients, 108 CIN 3 or CIN 2 patients after treatment and 62 CIN 1 or CAC patients after remission; and (iii) 323 apparently normal subjects (ANS) without any cervical disease. The HPV genotypes of the infected patients were confirmed by direct sequencing. Quantitative real-time PCR (QRT-PCR) was used to measure the MB HPV16 load for 15 infected patients. Results showed that the sensitivity, specificity, and positive and negative predictive values for detection of MB HPV DNA in samples from patients with CIN or CAC were 82.8%, 93.1%, 90.0%, and 87.9%, respectively. Moreover, MB HPV DNA was found in samples from 22.2% of CIN 3 or CIN 2 patients after treatment, 0.0% of CIN 1 or CAC patients after remission, and 8.1% of ANS, 4 of whom were found to have CIN 1 or CAC. Furthermore, QRT-PCR showed that the normalized MB HPV16 DNA copy numbers in samples from patients with CIN 1 to CIN 3 were significantly increased. These preliminary results suggested that MB HPV DNA is a potential noninvasive marker for these premalignant cervical diseases.
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A modified sanitary napkin was compared with endocervical swab and urine specimens for the detection of urogenital Chlamydia trachomatis infection. Endocervical swabs and/or first-catch urine were collected from 510 women at medical or community settings in Quebec City. Participants were also asked to wear a modified sanitary napkin (Ezy-Detek) during 4 consecutive hours and to bring it back to the clinic or mail it to the laboratory. Endocervical and urine specimens were tested using the Cobas Amplicor CT/NG assay (Roche Diagnostic Systems) according to the manufacturer's instructions, as were specimens collected with the napkin after adequate preparation. If the PCR test result was positive on the endocervical sample or on any two samples, a woman was considered to be infected. PCR testing results on paired samples were identical for 493 (96.6%) of 510 women. According to the definition given above, 58 (11.3%; 95% confidence interval [CI], 8.7 to 14.5%) women were infected with C. trachomatis. The sensitivity and specificity of PCR testing on modified sanitary napkin specimens were, respectively, 93.1% (54 of 58; 95% CI, 83.3 to 98.1%) and 98.9% (447 of 452; 95% CI, 97.4 to 99.6%) compared to 81.0% (47 of 58; 95% CI, 68.6 to 90.1%) and 100% (451 of 451; 95% CI, 99.2 to 100%) for urine specimens. The positive and negative predictive values were, respectively, 91.5% (54 of 59) and 99.1% (447 of 451) for the sanitary napkin specimens compared to 100% (47 of 47) and 97.6% (451 of 462) for urine samples. These results suggest that a modified sanitary napkin represents an effective noninvasive device for self-collection of specimens to detect urogenital C. trachomatis infection.
Background: Minimally invasive fingerstick sampling allows testing of reproductive hormone levels at home, providing women with increased access to tests that can screen for conditions such as polycystic ovarian syndrome, primary ovarian insufficiency, and pituitary and thyroid dysfunction. Method: We present a measurement procedure comparison study of matched venipuncture and fingerstick samples from 130 women aged 18-40 years, tested on menstrual cycle day 3. Samples were measured for anti-müllerian hormone, estradiol (E2), follicle-stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), testosterone, thyroid-stimulating hormone (TSH), and free thyroxine (T4) levels. Samples were tested using U.S. Food and Drug Administration-cleared immunoassays, with a modified reconstitution step for fingerstick samples. Experience: Venipuncture and fingerstick hormone values were concordant and linear across all assay ranges. There was no evidence of systematic bias across the assay ranges, and bias measures were below recommended guidelines. The correlation between venipuncture and fingerstick was between 0.99 and 1.0 for each hormone. Each assay displayed a high degree of precision (less than 13% coefficient of variation) and a high level of accuracy (average recovery equaled 95.5-102.3%). Conclusion: Venipuncture and fingerstick samples can be used interchangeably to measure anti-müllerian hormone, E2, FSH, LH, PRL, testosterone, TSH, and free T4 levels. Fingerstick sampling provides doctors and women more convenient testing options. Funding source: The study was sponsored by Modern Fertility.
Human papillomavirus was successfully detected by polymerase chain reaction (PCR) in menstrual blood or vaginal discharge collected in sanitary napkins in 100% of 17 women having koilocytosis, cervical intraepithelial neoplasia, or squamous carcinoma. We advocate this form of cervical cancer screening because of its high sensitivity and acceptance by patients.