Primary immunodeficiency testing in a Massachusetts tertiary care NICU: persistent challenges in the extremely premature population.

BACKGROUND: Prematurity presents a diagnostic challenge in interpreting primary immunodeficiency (PID) testing. METHODS: We retrospectively reviewed the charts of all infants in our level IV referral neonatal intensive care unit (NICU) in Massachusetts, with immunologic testing performed from 2006 to 2018. RESULTS: The overall rate of PID testing was enriched in our population, with 1% of admitted patients having extended immunologic testing. The addition of TREC (T cell receptor excision circle) newborn screening in Massachusetts in 2009 increased the proportion of infants tested for PID in our NICU by 3-fold (1.21% post-newborn screening (NBS) vs. 0.46% pre-NBS). A majority of the term and late preterm (≥34 weeks) infants (31 of 41, 76%), as well as very premature (29-33 weeks) infants (12 of 17, 71%), who had immune testing, had a genetic diagnosis associated with secondary immunodeficiency or a PID. Most infants who were born extremely premature (EP, <29 weeks) (25 of 29, 86%) had no identifiable cause of immunodeficiency besides prematurity, despite a mean postmenstrual age of 40.1 weeks at the time of testing. CONCLUSIONS: Persistent immune derangements were present within a subgroup of the EP population through term postmenstrual age. EP infants with significant infectious history and abnormal immune testing at term-corrected age should be considered for genetic testing. IMPACT: The role of immunologic testing in the premature population is unclear, we therefore reviewed the records of all infants in our NICU who had immunologic testing, to rule out immunodeficiency, done from 2006 to 2018. The addition of newborn screening for SCID in 2009 doubled the number of infants who had immune investigations. The extremely premature cohort included many infants with persistent immune derangements through term-corrected gestational age, suggesting a persistent effect of prematurity on immune development and potential function. We propose that former premature infants with clinical evidence of immunodeficiency and sustained immune abnormalities by term-corrected age undergo genetic testing for immunodeficiency.

Frequency of positive oral food challenges and their outcomes in the allergy unit of a tertiary-care pediatric hospital.

INTRODUCTION AND OBJECTIVE: The oral food challenge (OFC) is the gold standard to diagnose food allergy (FA); however, it is not a procedure free from the risk of having significant allergic reactions, even life-threatening.The aims of our study were to evaluate the frequency of positive OFCs performed in children with a suspected diagnosis of IgE- and non-IgE-mediated (food protein-induced enterocolitis syndrome (FPIES)) FA and how the failed challenges were managed. MATERIALS AND METHODS: A retrospective chart review was done on all children who have had OFCs in a tertiary-care pediatric allergy unit from 2017 to 2019. RESULTS: 682 patients were enrolled and 2206 challenges were performed: 2058 (93%) for IgE-mediated FA and 148 (7%) for FPIES. There were 262 (11.8%) challenge failures. The transfer to the emergency department was required 3 times (1.1%). None of the failed challenges resulted in death or hospitalization and 13.3% challenges did not require any treatment. CONCLUSIONS: Our findings confirm that food challenges can be performed safely in a specialized setting by well-trained personnel; all food challenge reactions, even the most serious, were reversible, thanks to a prompt recognition and treatment that generally did not worsen over time.

The new IVD Regulation 2017/746: a case study at a large university hospital laboratory in Belgium demonstrates the need for clarification on the degrees of freedom laboratories have to use lab-developed tests to improve patient care.

Objectives: The new European In Vitro Diagnostic (IVD) Regulation 2017/746 (IVDR) restricts the use of lab-developed tests (LDT) after 26th May 2022. There are no data on the impact of the IVDR on laboratories in the European Union. Methods: Laboratory tests performed in UZ Leuven were divided in four groups: core laboratory, immunology, special chemistry, and molecular microbiology testing. Each test was classified as Conformité Européenne (CE)-IVD, modified/off-label CE-IVD, commercial Research Use Only (RUO) or LDT. Each matrix was considered a separate test. Results: We found that 97.6% of the more than 11.5 million results/year were generated with a CE-IVD method. Of the 922 different laboratory tests, however, only 41.8% were CE-IVD, 10.8% modified/off-label CE-IVD, 0.3% RUO, and 47.1% LDT. Off-label CE-IVD was mainly used to test alternative matrices not covered by the claim of the manufacturer (e.g., pleural or peritoneal fluid). LDTs were mainly used for special chemistry, flow cytometry, and molecular testing. Excluding flow cytometry, the main reasons for the use of 377 LDTs were lack of a CE-IVD method (71.9%), analytical requirements (14.3%), and the fact the LDT was in use before CE-IVD available (11.9%). Conclusions: While the large majority of results (97.6%) were generated with a CE-IVD method, only 41.8% of laboratory tests were CE-IVD. There is currently no alternative on the market for 71.5% of the 537 LDTs performed in our laboratory which do not fall within the scope of the current IVD directive (IVDD). Compliance with the IVDR will require a major investment of time and effort.

Association between rapid antigen detection tests and antibiotics for acute pharyngitis in Japan: A retrospective observational study.

The application and clinical impact of rapid antigen detection test (RADT) in the treatment of acute pharyngitis is unknown in Japan. We aimed to examine the proportions of RADT usage to identify Group A ß-hemolytic Streptococcus (GAS) in outpatients with acute pharyngitis and evaluate the association between RADT and antibiotic treatment. We analyzed health insurance claims data from 2013 to 2015. Logistic regression models were used to analyze associated factors with RADT, overall antibiotic prescription, or penicillin use. We analyzed 1.27 million outpatient visits with acute pharyngitis, in which antibiotics were prescribed in 59.3% of visits. Of the total visits, 5.6% of patients received RADT, and 10.8% of the antibiotics were penicillin. Penicillin selection rates were higher in cases with RADT (25.4%) than those without RADT (9.7%). Compared to large-scale facilities, antibiotic prescription rates were higher in physicians' offices. For factor analysis, age (3-15 years), diagnosis code (streptococcal pharyngitis), size of the medical facility (large-scale hospitals), and physician's specialty (pediatrics) were associated with RADT use. Penicillin selection rate increased with RADT implementation (25.4% vs. 9.7%: adjusted odds ratio 1.55; 95% CI, 1.50-1.60). At 63% of the facilities, the RADT implementation rate was <5% of acute pharyngitis visits prescribed antibiotics. In conclusion, the proportion of RADT usage for outpatients with acute pharyngitis was low in Japan. With appropriate indication and evaluation, we expect that more utilization of RADT can help promote antimicrobial stewardship for outpatients with acute pharyngitis by prompting penicillin therapy. Further investigation with detailed clinical data are warranted.

Detection of Colorectal Neoplasia in a Cohort Before and After the Change of Fecal Occult Blood Test in a French Colorectal Cancer Screening Program.

OBJECTIVE: To estimate the change in the participation rate and the change in neoplasia incidence before and after the change of the Fecal Occult Blood Test (FOBT) in the cohort included in the Colorectal Cancer Screening Program (CRCSP). METHODS: Cohort of 279,210 people, aged 50-74 years, invited at least once before 2009, to participate in a CRCSP campaign. The participation rate and the cumulative neoplasia incidence were described on 4 campaigns (≤2008, 2009-2010, 2011-2012 and 2013-2014) with a Guaiac FOBT (gFOBT) and a first campaign (2015-2016) with a Fecal Immunochemical Test (FIT). The cumulative incidence was estimated by the actuarial method and its confidence interval by the Greenwood method. RESULTS: The participation rate decreased from 32.7% (first gFOBT-campaign) to 24.4% (fourth gFOBT-campaign) then, made a significant bound in the FIT-campaign (28.4%; p < 0.001). 35.4% of the 965 high-risk-polyps screened in this cohort were detected in the FIT-campaign. CRC incidence gradually decreased from 0.4 to 0.1/1000 person-years from the first to the fourth gFOBT-campaign before reaching a bound to 0.4/1000 person-years in the FIT-campaign. CONCLUSION: Although it was still below the minimum European target (45%), the participation rate has increased between the last gFOBT-campaign and FIT-campaign, justifying the impact of promotional campaigns and the acceptance of the new test by people and GPs. A decline in the neoplasia incidence was observed between the initial and the fourth gFOBT-campaign. The change from gFOBT to FIT between the fourth and fifth campaigns, was associated with a significant increase in detection of neoplasia.

A Randomized Controlled Trial of Opt-in Versus Opt-Out Colorectal Cancer Screening Outreach.

OBJECTIVES: METHODS:: RESULTS:: Patients randomized to opt-in agreed to participate 23.1% of the time, and only 2.5% of those in opt-out chose not to participate. FIT kits were mailed to 22.4% and 93% of patients in opt-in and opt-out arms, respectively. In intention-to-screen analysis, patients in the opt-out arm had a higher FIT completion rate (29.1%) than in the opt-in arm (9.6%) (absolute difference 19.5%; 95% confidence interval, 10.9-27.9%; P < .001). Results were similar in subgroup analysis of those sent initial messaging through the EHR portal (9.5% opt-in versus 37.5% in opt-out). CONCLUSIONS: .

Rapid antigen test use for the management of group A streptococcal pharyngitis in community pharmacies.

Despite group A streptococci being an infrequent cause of pharyngitis in adult outpatients, sore throat remains a common indication for antibiotic prescription. This prospective multicentre non-randomised study describes a community pharmacy-based antimicrobial stewardship intervention consisting in the implementation of rapid antigen testing (RAT) for the management of adults with sore throat. Trained pharmacists triaged patients presenting with symptoms of pharyngitis using the modified Centor score. Those at risk for streptococcal infection were tested with RAT. Patients with a positive RAT were invited to consult a physician, whereas others were offered a symptomatic treatment. All patients received educational leaflets and were asked to fill in a follow-up form 7 days later. Ninety-eight pharmacies in one French region participated, and 559 patients were included over 6 months. RAT was proposed in 367 (65.7%) cases, and it was positive in 28 (8.3%). The follow-up form was returned by 140 (38.5%) participants. Of these, 10/10 patients with positive RAT further consulted a physician and were prescribed an antibiotic treatment, whereas 96.5% (110/114) of patients with negative results and not having any other reason to seek for doctor's advice did not consult. All participants found the intervention useful. Pharmacists spent 6-15 min to perform the intervention, and 98.6% (73/74) of pharmacists giving a feedback declared to be ready to implement this intervention in daily practice, if endorsed and reimbursed. Our results suggest that a pharmacy-based programme for the management of sore throat is feasible and could increase adherence to guidelines.

Gastrointestinal Symptoms of Food Challenge-proven Non-IgE Cow's Milk Allergy Are Dissipated by Early School Age.

OBJECTIVES: The aim of this study was to evaluate the current well-being and dietary restrictions in children 6 years after food challenge-confirmed diagnosis of non-IgE cow's milk protein allergy, compared to peers with gastrointestinal symptoms but negative food challenge. This study aimed to evaluate the diagnostic process retrospectively. METHODS: This is an Internet-based survey for mothers whose children underwent 6 years ago the double-blind, placebo-controlled food challenge for cow's milk (CM) because of gastrointestinal symptoms causing suspicion of non-IgE CM protein allergy. Concurrent dietary restrictions, overall well-being, medical history, and retrospective views on the food challenge were queried using a study-specific questionnaire, the Quality of life using PedsQL general score and parental stress with the Parenting Stress Index questionnaire. RESULT: Mothers of 42 children (23 girls), median age of 6.7 years (range 5.7-8.6), participated in the survey, the response rate was 70%. All children now consumed cow's milk protein. The only food restrictions reported were empirical lactose-free diets in 7 children (17%). One-third of the children in both groups were presently reported to have eating-related issues such as picky eating. Quality of life was good and present parenting stress was average in both groups. The majority of the mothers (87%) felt positive or neutral about the food challenge performed in infancy. CONCLUSIONS: The non-IgE CM allergy with gastrointestinal symptoms diagnosed in infancy was a transient condition with good outcome. At an early school age, nearly all children have a good quality of life and a regular diet. The use of the double-blind, placebo-controlled food challenge was well-endorsed.

Comprehensive activities to increase recognition of primary immunodeficiency and access to immunoglobulin replacement therapy in Poland.

UNLABELLED: The study presents an overview on current situation of primary immunodeficiency (PID) patients in Poland and the 2014 annual report of the Polish Working Group for Immunodeficiency (PWGID). The group was set up in 2005 to improve diagnosis, treatment, and care of patients with immunodeficiencies and currently includes 15 pediatric and 13 adult centers. According to PWGID report 4099, PID patients are recognized in Poland, with the prevalence 10.6/100,000. The majority of them (54.2 %) have predominantly antibody deficiency (PAD). In 2014 alone, a total number of 731 newly diagnosed individuals are reported. As predicted, the vast majority (70 %) of them have PAD. Approximately one third of PAD patients require immunoglobulin replacement therapy. Within the entire cohort, an intravenous route of immunoglobulin therapy dominates (67.3 %). However, within the age groups, distribution of immunoglobulin therapy varies and seems to be age related. Among children, 36 % receive subcutaneous immunoglobulin, while with adults 26 %. CONCLUSION: Analysis of numbers of either newly recognized or treated patients indicates its dynamic increase in recent years. This is the result of comprehensive activities by PWGID supported by governmental institutions, outstanding foundations, and patient's organization. WHAT IS KNOWN: • Immunoglobulins' treatment has substantially changed the life of individuals with PAD. Patients with common variable immunodeficiency (CVID) or X-linked agammaglobulinemia (XLA) can live and lead a near normal life. Early diagnosis of the disease followed by earlier implementation of appropriate treatment, including gammaglobulin replacement therapy, improves the quality of life. • Targeted efforts of health care professionals and government are required to optimize diagnostic and therapeutic approach for PAD. What is New: • Comprehensive activities of PWGID lead to better recognition of PID individuals and should improve reporting Polish PIDs to the ESID database. • Following the joint efforts of immunologists, patient's, and governmental organizations in the end of 2014, the Therapeutic Program for Treatment Adults with PID was introduced, leading to universal access to currently available treatment options and to improve the quality of life.

Use and Interpretation of a Rapid Respiratory Syncytial Virus Antigen Detection Test Among Infants Hospitalized in a Neonatal Intensive Care Unit - Wisconsin, March 2015.

On March 25, 2015, the Wisconsin Division of Public Health was notified of a possible respiratory syncytial virus (RSV) infection outbreak among infants hospitalized in a neonatal intensive care unit (NICU). On March 23, the index patient (neonate A), aged 3 days, had feeding intolerance and apnea. A nasopharyngeal swab specimen collected from neonate A was tested using a single-manufacturer rapid RSV antigen detection test (RRADT) at the hospital laboratory; the result was positive. The following day, because of concern about the possibility of more widespread RSV infection, RRADT was used to test nasopharyngeal swab specimens from neonate B, aged 1 month, who had resided in a different hospital room in the NICU and had developed an increased oxygen requirement, apnea, and poor feeding that day, as well as from two asymptomatic neonates who were hospitalized in the same room with neonate A; all three were positive. Later that day, nasopharyngeal swab specimens from the remaining 16 asymptomatic NICU patients were tested using the same RRADT; seven tests were positive, making a total of 11 positives. All 20 RRADTs were performed at the hospital laboratory.

HIV testing rates and co-infection among patients with tuberculosis in south-eastern Sydney, 2008-2013.

OBJECTIVE: To evaluate the rate of HIV and tuberculosis co-infection and changes in HIV testing practices for patients with tuberculosis managed in South Eastern Sydney Local Health District (SESLHD), New South Wales, Australia. DESIGN, PARTICIPANTS AND SETTING: A retrospective review of tuberculosis notification data from four public tuberculosis treatment clinics in SESLHD (population, >800,000), 2008-2013. Data were extracted from the NSW Notifiable Conditions Information Management System. INTERVENTION: Published evidence regarding clinical management of HIV and tuberculosis co-infection and feedback of HIV testing rates was provided to senior clinicians managing tuberculosis in SESLHD between 2008 and 2012. MAIN OUTCOME MEASURES: Proportion of patients with tuberculosis with HIV infection status ascertained and proportion with HIV co-infection. RESULTS: Of 506 people with notified tuberculosis treated in SESLHD during the study period, 369 had their HIV status ascertained (72.9%), of whom 20 were HIV co-infected (5.4%). Eleven of these cases were new HIV diagnoses. Seven people offered an HIV test declined the offer. The rates of HIV co-infection varied between clinics (1.5%-9.7%; P=0.02) as did the rate of HIV status ascertainment (61.5%-85.4%; P<0.001). The rate of HIV status ascertainment increased between 2008 and 2013 (52.9%-87.1%; P<0.001). CONCLUSIONS: The rate of HIV co-infection among people treated for tuberculosis in south-eastern Sydney is of clinical importance. Rates of HIV testing in this population have increased, but further gains are desirable. It is unclear if the intervention influenced the increase in HIV testing rates.

Diagnostic accuracy of the Aspergillus-specific bronchoalveolar lavage lateral-flow assay in haematological malignancy patients.

We evaluated the performance of the Aspergillus-specific lateral-flow device (LFD) test for diagnosing invasive pulmonary aspergillosis (IPA) in patients with underlying haematological malignancies. Participating centres were the two Austrian University Hospitals of Graz and Innsbruck. LFD performance was evaluated with 95 bronchoalveolar lavage fluid (BALF) samples from 72 patients collected prospectively in Graz, and with 24 BALF bio bank samples from 23 patients (21 samples with probable IPA) in Innsbruck. Invasive fungal infections were classified according to the revised European Organization of Research and Treatment of Cancer/Mycoses Study Group criteria. Overall, 27 patients (30 samples) had probable IPA, 32 (43 samples) possible and 36 (46 samples) did not fulfil IPA criteria. The vast majority of patients - in particular those with probable IPA - received mould-active treatment before bronchoscopy. Sensitivity, specificity, positive predictive value and negative-predictive-value for probable IPA diagnosis using the BALF-LFD test were 71%, 76%, 35% and 94% for the Graz cohort. Sensitivity of the BALF-LFD test for probable IPA was 57% in Innsbruck bio bank samples. Our results indicate that the BALF-LFD-test provides fast results with moderate sensitivities in patients with underlying haematological malignancies. Similar to other diagnostic tests and biomarkers sensitivity of the test may be influenced by ongoing systemic mould-active treatment.

Laparoscopic cholecystectomy in elderly patients: an evaluation of immunity.

OBJECTIVE: We sought to investigate the impact of laparoscopic cholecystectomy (LC) on the inflammatory response and immunological function of elderly patients compared with that on the younger ones. METHODS: Between June 2012 and June 2013, this prospective study investigated a total of 112 patients having the surgery of LC due to symptomatic cholelithiasis or polyps, among whom 52 were elderly patients with the age beyond 65 years old and the remaining 60 were younger than the age. Peripheral venous blood samples were taken from these patients prior to surgery and on post-operative days 1, 3 and 7, respectively. The perioperative clinical outcomes and immunological function results were analyzed and compared between the two groups divided by age. RESULTS: The demographics of the two groups did not differ except for the age. Surgical trauma seemed more serious for elderly patients as illustrated by the longer operating time, hospital stay and more quantity of patients got complication. Both groups indicated changes in inflammatory and immune aspects. Compared with the younger ones, elderly patients showed less quantity of preoperative basic immune cells, delayed immune responses after the surgical trauma of LC and hyporeactivity of inflammatory response when accepting LC. CONCLUSIONS: An examination of the inflammatory reaction and immune response after LC demonstrated that there are significant differences observed in two groups divided by age. Further studies with more samples are required to determine the exact relationship of perioperative immune change and higher adverse outcome rate of aged people.

Near-patient tests and the clinical gaze in decision-making of Swedish GPs not following current guidelines for sore throat - a qualitative interview study.

BACKGROUND: Excessive antibiotics use increases the risk of resistance. Previous studies have shown that the Centor score combined with Rapid Antigen Detection Test (RADT) for Group A Streptococci can reduce unnecessary antibiotic prescribing in patients with sore throat. According to the former Swedish guidelines RADT was recommended with 2-4 Centor criteria present and antibiotics were recommended if the test was positive. C- reactive protein (CRP) was not recommended for sore throats. Inappropriate use of RADT and CRP has been reported in several studies. METHODS: From a larger project 16 general practitioners (GPs) who stated management of sore throats not according to the guidelines were identified. Half-hour long semi-structured interviews were conducted. The topics were the management of sore throats and the use of near-patient tests. Qualitative content analysis was used. RESULTS: The use of the near-patient test interplayed with the clinical assessment and the perception that all infections caused by bacteria should be treated with antibiotics. The GPs expressed a belief that the clinical picture was sufficient for diagnosis in typical cases. RADT was not believed to be relevant since it detects only one bacterium, while CRP was considered as a reliable numerical measure of bacterial infection. CONCLUSIONS: Inappropriate use of near-patient test can partly be understood as remnants of outdated knowledge. When new guidelines are introduced the differences between them and the former need to be discussed more explicitly.

The sensitivity of T-SPOT.TB assay in diagnosis of pediatric tuberculosis.

This study was performed aiming to evaluate the sensitivity of T-SPOT.TB assay in diagnosis of pediatric TB and investigate the association between age and results of T-SPOT.TB assay. Between March 2012 and September 2013, 102 patients, who aged ≤15 years old, were enrolled in this retrospective study and then were grouped into three age categories: Group 1, aged ≤2 years; Group 2, aged 3 to 12 years; and Group 3, aged 13 to 15 years. The χ(2) test was used to compare the sensitivities of T-SPOT.TB between groups with different ages. The overall sensitivity of T-SPOT.TB assay was 58.8% (95% confidence interval: 49.1-67.9%) and low in diagnosis of pediatric TB. Although the sensitivities varied in the three groups, the difference did not reach statistical significance (p > 0.05). Therefore, in high burden countries, T-SPOT.TB assay wasn't accurate in diagnosis of pediatric TB, and age was not associated with the results of T-SPOT.TB.

Not FIT for Use: Fecal Immunochemical Testing in the Inpatient and Emergency Settings.

BACKGROUND: Fecal immunochemical testing (FIT) is widely used for colorectal cancer screening, its only indication. Its effect on clinical decision-making beyond screening is unknown. We studied the use of FIT in emergency and inpatient settings and its impact on patient care. METHODS: Using electronic medical records, we reviewed all non-ambulatory FITs performed from November 2017 to October 2019 at a tertiary care community hospital. We collected data on demographics, indications, gastroenterology consultations, and endoscopic procedures. Multivariate logistic regression was performed to determine the effect of FIT on gastroenterology consultation and endoscopy. RESULTS: We identified 550 patients with at least 1 FIT test. Only 3 FITs (0.5%) were performed for colorectal cancer screening. FITs were primarily ordered from the emergency department (45.3%) or inpatient hospital floor (42.2%). Anemia (44.0%), followed by gastrointestinal bleeding (40.9%), were the most common indications. FIT was positive in 253 patients (46.0%), and gastroenterology consultation was obtained for 47.4% (n = 120), compared with 14.5% (n = 43) of the 297 FIT-negative patients (odds ratio 3.28; 95% confidence interval, 2.23-4.82, P < .0001). A potential bleeding source was identified in 80% of patients with reported or witnessed overt gastrointestinal bleeding, a similar proportion (80.7%; P = .92) to patients who were FIT positive with overt gastrointestinal bleeding. Multivariate analysis showed that melena, hematemesis, and a positive FIT were associated with gastroenterology consultation (all P < .05), while only melena (odds ratio 3.34; 95% confidence interval, 1.48-7.54) was associated with endoscopy. CONCLUSIONS: Nearly all emergency department and inpatient FIT use was inappropriate. FIT resulted in more gastroenterology consultation but was not independently associated with inpatient endoscopy.

Effects of antithrombotic drugs on the results of fecal immunochemical test in colorectal neoplasms screening.

Fecal immunochemical test (FIT) is widely used as a colorectal cancer screening tool. Antithrombotic drugs may affect the screening performance of FIT for colorectal tumors. The aim of this study was to clarify the effect of antithrombotic agents on FIT accuracy in screening for colorectal neoplasms. This retrospective study enrolled a total of 758 patients who underwent both FIT and total colonoscopy. The effect of antithrombotic drugs on FIT accuracy in detecting colorectal neoplasms (CN), including colorectal cancer (CRC), advanced adenoma (AA), and non-advanced adenoma (NAA), was examined. Of the 758 patients, 144 (19%) received antithrombotic drugs (administration group). In administration group, 61/144 (42%) cases had CN [CRC:14, AA:15, NAA:32] and 217/614 (35%) cases had CN (CRC:43, AA:56, NAA:118) in non-administration group. The prevalence of CN was not significantly different between the two groups (p = 0.1157). There was no significant difference in sensitivity or specificity of the detection of all types of CN with or without taking antithrombotic drugs. Neither the positive predictive value nor negative predictive value of FIT was affected by antithrombotic drug administration. Taking antithrombotic drugs may not have a large impact on sensitivity, specificity, positive predictive value, or negative predictive value of FIT in screening for CN.

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

BACKGROUND: A simple and inexpensive home sperm test could be of considerable value to couples attempting to conceive and to men curious about their fertility potential. A two-strip lateral flow immunochromatographic diagnostic device that allows men to evaluate their sperm count at low cost in the privacy of their own homes is described. METHODS: The ability of SpermCheck Fertility to predict sperm counts obtained using a hemacytometer procedure based on standard World Health Organization methodology was assessed. Test results obtained by lay users were also compared with those obtained by trained laboratory professionals, and the ease of use of the device was evaluated in consumer studies. RESULTS: A total of 225 semen samples were analyzed in the method comparison, and the performance of SpermCheck Fertility was excellent with over 96% of all samples correctly classified as normozoospermic (> or =2 x 10(7) sperm/ml), oligozoospermic (5 x 10(6)-2 x 10(7) sperm/ml) or severely oligozoospermic (<5 x 10(6) sperm/ml). Consumer studies with 164 lay users demonstrated that SpermCheck Fertility was easy to use. Lay users and laboratory professionals agreed 95% of the time when reading the same test independently. Overall, the correct response rate on a 20-question survey about the test was over 97%. CONCLUSIONS: SpermCheck Fertility is a simple and reliable immunodiagnostic test that can quickly inform men as to whether their sperm count is normal, low or very low. This home test can assist couples in deciding whether to seek comprehensive clinical evaluation of the fertility status of the male partner.