Home Test Kits Research Articles

Lateral Flow Immunoassay.

Lateral flow immunoassays (LFIAs) are a staple in the field of rapid diagnostics. These small handheld devices require no specialized training or equipment to operate, and generate a result within minutes of sample application. They are an ideal format for many types of home test kits, for emergency responders and for food manufacturers and producers looking for a quick evaluation of a given sample. LFIAs rely on high quality monoclonal antibodies that recognize the analyte of interest. As monoclonal antibody technology becomes more accessible to smaller laboratories, there has been increased interest in developing LFIA prototypes for potential commercial manufacture. In this chapter, the basics of designing and building an LFIA prototype are described.

Menstrual cycle phase effects in the gender dimorphic stress cue reactivity of smokers.

We previously reported that female smokers evidence greater subjective craving and stress/emotional reactivity to personalized stress cues than males. The present study employed the same dataset to assess whether females in the follicular versus luteal phase of the menstrual cycle accounted for the gender differences. Two objective criteria, onset of menses and luteinizing hormone surge (evaluated via home testing kits), were used to determine whether female smokers were in either the follicular (n = 22) or the luteal (n = 15) phase of their menstrual cycle, respectively. The females and a sample of male smokers (n = 53) were then administered a laboratory-based cue reactivity paradigm that involved assessment of craving, stress, and emotional reactivity in response to counterbalanced presentations of both a personalized stress script and neutral/relaxed script. While there were no significant differences between females in the follicular versus luteal phase on any outcome measure, females in the luteal menstrual phase reported greater craving than males whereas females in the follicular phase reported greater stress and arousal than males and perceived the stress cues as more emotionally aversive than males. This preliminary investigation suggests that gender differences in craving versus affective responding to stress cues may, in part, be explained variation by menstrual cycle phase. Study limitations and implications of the findings for future research and treatment are briefly discussed.

Pharmacists highlight concerns over law change governing HIV home-testing kits

Pharmacists highlight concerns over law change governing HIV home-testing kits

Prevalence and Factors Associated With Trichomonas vaginalis Infection Among High-Risk Women in Los Angeles

Remnant specimen from 1215 women screening for chlamydia/gonorrhea at 4 different venue types (sexually transmitted disease clinics, home-test kit users, juvenile and adult detention) in Los Angeles, California, were tested for Trichomonas vaginalis. Prevalence of T. vaginalis varied by screening population, and concurrent chlamydia or gonorrhea was independently associated with T. vaginalis.

Attitude and Behavior Changes Among Gay and Bisexual Men After Use of Rapid Home HIV Tests to Screen Sexual Partners

HIV testing can now be self-administered outside clinical settings through the purchase of home testing (HT) kits. Individuals also can use the kits to perform a test on a potential sexual partner prior to intercourse. We provided a 3-month supply of HT kits to men who reported multiple male partners and little or no condom use for anal intercourse. Participants used the test kits with partners in over 100 occasions. At the end of the study, approximately half of the participants described shifts in their attitudes and/or behaviors related to sexual risk. Reported changes included increased awareness of risk, increased discussion of STI/HIV safety measures, changes in partner choice and heightened consciousness of partner thinking. Easy access to HT kits may be a risk-reduction strategy for men with a high risk profile because their regular use could have an impact beyond the specific sexual encounter.

Assessing willingness to test for HIV among men who have sex with men using conjoint analysis, evidence for uptake of the FDA-approved at-home HIV test

Men who have sex with men (MSM) in the USA, represent a vulnerable population with lower rates of HIV testing. There are various specific attributes of HIV testing that may impact willingness to test (WTT) for HIV. Identifying specific attributes influencing patients' decisions around WTT for HIV is critical to ensure improved HIV testing uptake. This study examined WTT for HIV by using conjoint analysis, an innovative method for systematically estimating consumer preferences across discrete attributes. WTT for HIV was assessed across eight hypothetical HIV testing scenarios varying across seven dichotomous attributes: location (home vs. clinic), price (free vs. $50), sample collection (finger prick vs. blood), timeliness of results (immediate vs. 1–2 weeks), privacy (anonymous vs. confidential), results given (by phone vs. in-person), and type of counseling (brochure vs. in-person). Seventy-five MSM were recruited from a community-based organization providing HIV testing services in Los Angeles to participate in conjoint analysis. WTT for HIV score was based on a 100-point scale. Scores ranged from 32.2 to 80.3 for eight hypothetical HIV testing scenarios. Price of HIV testing (free vs. $50) had the highest impact on WTT (impact score = 31.4, SD = 29.2, p<0.0001), followed by timeliness of results (immediate vs. 1–2 weeks) (impact score = 13.9, SD = 19.9, p≤0.0001) and testing location (home vs. clinic) (impact score = 10.3, SD = 22.8, p=0.0002). Impacts of other HIV testing attributes were not significant. Conjoint analysis method enabled direct assessment of HIV testing preferences and identified specific attributes that significantly impact WTT for HIV among MSM. This method provided empirical evidence to support the potential uptake of the newly FDA-approved over-the-counter HIV home test kit with immediate results, with cautionary note on the cost of the kit.

At-home HIV testing: Educating patients

In July 2012, FDA approved the first oral HIV home test kit for use by adults 17 years and older. The OraQuick In-Home HIV Test from OraSure uses a gum swab from the patient's mouth and provides results within 20 minutes, so that patients can quickly learn their HIV status in the privacy of their own homes.

Viral load rebound in presumed elite controllers: a small case series of the potential use of non‐prescribed HAART in African patients

IntroductionHIV elite controllers are rare with an incidence of &lt;1/300 [1]. We report 4 cases of presumed elite control with subsequent viral load rebound possibly due to non‐prescribed HAART. Case 1: A 37‐year‐old African woman trafficked to the UK was diagnosed HIV‐positive with viral load (VL) &lt;40 copies/mL and CD4 count of 436 cells/cmm. She denied prior diagnosis and was presumed an elite controller until a rise in VL to 26,5205 copies/mL 6 months later (Table 1). Time from diagnosis CD4 (cells/cmm) Viral load (copies/mL) 0 436 (26%) &lt;40 1 month 424 (18%) &lt;40 3 months N/A &lt;40 6 months 387 (29%) 265,205 6 months 264 (18%) 338,291 A resistance test reported HIV‐1 subtype C with a minor protease inhibitor mutation (A71T). It was subsequently disclosed she was given unidentified tablets by traffickers. Case 2: A 31‐year‐old African woman presented 37 weeks pregnant and was diagnosed HIV‐positive with VL 147 copies/mL and CD4 count of 1065 cells/cmm. She denied prior diagnosis, however stated an African doctor visited her ex‐partner's home and supplied tablets identified as lopinavir/ritonavir and zidovudine/lamivudine. Clinics in this area were contacted but had no record of this patient. There was a rise in VL with a resistance test reporting HIV‐1 subtype C/D with no mutations. Case 3: A 53‐year‐old African woman presented 6 weeks after a sexual assault in her home country and was diagnosed HIV‐positive with VL&lt;40 copies/mL and CD4 count of 609 cells/cmm. She denied prior diagnosis but stated her employers gave her unidentified tablets after the assault. Over 3 months VL increased to 390,751 copies/mL (Table 2). Time from diagnosis CD4 (cells/cmm) Viral load (copies/mL) 0 609 (30%) &lt;40 1 month 763 (29%) &lt;40 2 months N/A 417 4 months 616 (19%) 390,751 6 months 237 (18%) 67,833 A resistance test reported HIV‐1 subtype A with no mutations. Case 4: A 42‐year‐old African man was diagnosed HIV positive with VL 269 copies/mL and CD4 count of 562 cells/cmm. A resistance test reported HIV‐1 subtype B with minor PI and NRTI mutations (L10V and V118L respectively). HIV parameters remained stable until 20 months later with an increase in VL to 1,463,132 copies/mL (Table 3). Time from diagnosis CD4 (cells/cmm) Viral load (copies/mL) 0 562 (33%) 269 3 months 454 (37%) 810 6 months 456 (29%) 1110 9 months 492 (31%) 1013 14 months 473 (27%) 199 20 months 279 (13%) 1,463,132 20 months 299 (12%) 1,070,823 A resistance test excluded super‐infection reporting a similar sequence and no new mutations. Co‐existing pathology was also excluded. He subsequently disclosed taking medication supplied by his family but denied this was HAART.ConclusionThe viral load rebound seen in these cases may be due to a viral or immune mediated phenomenon; however, the possibility of non‐prescribed HAART has to be considered. Home test kits for HIV are widely available and there are reports of counterfeit HAART in the developing world [2]. The HIV community has to be vigilant in reporting cases of this nature which create many anxieties regarding toxicity and resistance.

Quality and use of consumer information provided with home test kits: room for improvement.

Diagnostic self-tests (tests on body materials that are initiated by consumers with the aim of diagnosing a disorder or risk factor) are becoming increasingly available. Although the pros and cons of self-testing are currently not clear, it is an existing phenomenon that is likely to gain further popularity. To examine consumers' use of and needs for information about self-testing, and to assess the quality of consumer information provided with home test kits, as perceived by consumers and as assessed using a checklist of quality criteria. A cross-sectional Internet survey among 305 self-testers assessed their use of and needs for information and their perception of the quality of consumer information provided with self-test kits. A meta-search engine was used to identify Dutch and English consumer information for home diagnostic tests available online at the time of the study. The quality of this consumer information was evaluated using a checklist of quality criteria. The consumers' information needs were in line with the most frequently used information, and the information was perceived as being of moderate to good quality. The information was mostly in agreement with clinical practice guidelines, although information on reliability and follow-up behaviour was limited. Approximately half of the instruction leaflets did not include information on the target group of the test. Although generally of moderate to good quality, some aspects of the information provided were in many cases insufficient. European legislation concerning self-tests and accompanying information needs to be adapted and adhered to more closely.

Direct-to-Consumer Disease Screening with Finger-Stick Testing: Online Patient Safety Risks

The direct-to-consumer (DTC)6 medical industry (i.e., medical testing and treatment outside of physician oversight) is growing rapidly as the Internet becomes more accessible globally. As several studies have highlighted, this industry offers unproven medical testing, provides testing for unapproved indications, and uses suspect advertising claims (1,–,5). Furthermore, given the prevalence of illicit pharmaceutical marketing (6), consumers are confronted with systemic online self-diagnosis and self-treatment risks that have emerged as a global patient safety and public health issue. One particularly troubling practice DTC companies commonly use is finger-stick (capillary blood) testing for disease screening and diagnosis. Although useful in some clinical point-of-care applications, finger-stick testing carries substantial risks when offered to the consumer for screening, diagnosis, or disease monitoring without professional oversight. Although other nonvenipuncture alternative-site testing carries many of the same risks, we focus specifically on the dangers of finger-stick testing because of its widespread use by DTC vendors. Because of the present situation and the unique patient safety risks we outline below (e.g., low diagnostic sensitivity, strip factors, logistics of testing), creating a regulatory framework for finger-stick testing could ensure legitimate evidence-based applications, patient safety protections, and responsible advertising that accurately reflects risks and utility. Offering DTC finger-stick medical testing in conjunction with information suggesting potentially abnormal results may in fact constitute unauthorized medical practice. According to the Federation of State Medical Boards, medical practice includes “offering or undertaking to prevent or diagnose … by any means … or devices any disease, illness, pain, … or abnormal physical condition of any person … .” (7). Many DTC medical-testing companies seem to fit squarely within this definition. Indeed, a simple Google search for “home testing kits” yields a panoply of DTC finger-stick tests: lipids (total, LDL, and HDL cholesterol; triglycerides), high-sensitivity C-reactive protein (hs-CRP), aspartate …

Saliva: A Powerful Diagnostic Tool for Minimal Intervention Dentistry

Saliva plays a vital role in oral health as patients strive to maintain a healthy dentition throughout their lives. It is natures primary defense mechanism for the oral environment, and is particularly important for protecting exposed tooth surfaces. While internal protection for dentin comes from odontoblasts and the dental pulp, the body's external protection for enamel comes from saliva. The noninvasive nature of salivary testing has made it an effective alternative to blood and urine testing and home testing kits have made it possible for people to monitor their own health using this diagnostic medium. This paper presents what saliva can reveal about general and oral health as well as highlights the current use and potential clinical and research applications, of diagnostics based on oral fluids. Early detection always minimizes the need for more invasive treatment. It prevents oral health disease at an early stage and provides a good oral health in rejuvenated state. If you stick and follow regular professional care, prevention maintenance appointments, prevention counseling, good home care and oral hygiene, diet habits you will be free from oral health illness and you can experience the harmonious and rejuvenated state of good oral health.

Acceptability of the Internet-Based Chlamydia Screening Implementation in the Netherlands and Insights Into Nonresponse

The study assessed the acceptability of internet-based Chlamydia screening using home-testing kits among 16- to 29-year-old participants and nonparticipants in the first year of a Chlamydia Screening Implementation program in the Netherlands. Questionnaire surveys were administered to randomly selected participants (acceptability survey) and nonparticipants (nonresponse survey) in 3 regions of the Netherlands where screening was offered. Participants received email invitations to an online survey; nonparticipants received postal questionnaires. Both surveys enquired into opinions on the screening design, reasons for (non-) participation and future willingness to be tested. The response rate was 63% (3499/5569) in the acceptability survey and 15% (2053/13,724) in the nonresponse survey. Primary motivation for participating in the screening was "for my health" (63%). The main reason for nonresponse given by sexually active nonparticipants was "no perceived risk of infection" (40%). Only 2% reported nonparticipation due to no internet access. Participants found the internet (93%) and home-testing (97%) advantages of the program, regardless of test results. Two-thirds of participants would test again, 92% via the screening program. Half of nonparticipants were appreciative of the program design, while about 1 in 5 did not like internet usage, home-testing, or posting samples. The screening method was highly acceptable to participants. Nonparticipants in this survey were generally appreciative of the program design. Both groups made informed choices about participation and surveyed low-risk nonparticipants accurately perceived their low-risk status. Although many nonparticipants were not reached by the nonresponse survey, current insights on acceptability and nonresponse are undoubtedly valuable for evaluation of the current program.

Screening for sexually transmitted infections at home or in the clinic?

The aim is to assess the evidence in support of home-based versus clinic-based screening for sexually transmitted infections. Home-based screening for sexually transmitted infections has been shown to be a feasible approach for men and women from a variety of settings, including high-risk, low-income, and resource-poor communities. In recent studies, the testing rate with home-based screening was up to 11 times greater than the testing rate with clinic-based screening. For most individuals, self-collection and testing of urine or vaginal specimens at home was considered to be easy, acceptable, and often preferred over testing at a clinic. There is limited evidence with regard to the cost effectiveness of home-based versus clinic-based screening for sexually transmitted infections. However, a study from the United States concluded that home-based screening is cost saving. Improvements in screening rates for sexually transmitted infections can be achieved with home-based screening methods. Making low-cost home test kits available may encourage at-risk young individuals with less access to clinic care, who may not otherwise be screened, to self-test for sexually transmitted infections.

Clinical Implications of Ovarian Reserve Testing

Serum and urinary markers of ovarian reserve, follicular phase inhibin B, follicle stimulating hormone, and antimullerian hormone levels, are physiologically associated with ovarian aging, decline with chronologic age, and appear to predict later stages of reproductive aging including the menopause transition and menopause. In infertile women, they can be used to predict low oocyte yield and treatment failure in women undergoing in vitro fertilization. These markers seem to be affected by common ovarian toxicants, such as smoking, which advance the age at menopause. Although available for commercial use, home test kits have not been shown to predict fertility or infertility in the general population. Clinical use of these markers is limited by the variety of assays, lack of definitive thresholds, and their intercycle variability in older women. Results should be conveyed with caution when highly discrepant with age, in the obese, and in women with irregular menstrual cycles. Further research is needed to assess their predictive value for determining fertility in the general population.

Reliability of spot test kits for detecting lead in household dust

There has been a long-standing need for a technique that can provide fast, accurate and precise results regarding the presence of hazardous levels of lead in settled house dust. Several home testing kits are now available. One kit manufactured by Hybrivet (LeadCheck Swabs) is advertised as able to detect lead dust levels that exceed the US Environmental Protection Agency's dust lead standard for floors (40 μg/ft 2). The purpose of the study was to determine the ability of LeadCheck Swabs to instantly detect lead in dust above EPA's hazard standard. A trained risk assessor collected 200 LeadCheck Swab samples side-by-side with standard dust wipe samples. The result of the LeadCheck Swab (positive (pink or red) or negative (yellow to brown)) was compared with the laboratory results for the corresponding dust wipe (over or under 40 μg/ft 2). The LeadCheck Swabs produced a false negative rate of 64% (95% confidence interval: 55%, 72%). The likelihood of a swab producing a false negative depended on substrate (painted or non-painted) and surface type (floor or sill). Changing the interpretation rule by classifying all swab colors except yellow as positive yielded lower false negative rates under some test conditions, but still produced high error rates. LeadCheck Swabs do not reliably detect levels of lead in dust above 40 μg/ft 2 using published methods under field conditions. Further research into alternate methodologies and interpretation guidance is needed to determine whether the swabs can be appropriately used by consumers and others to test homes for lead dust hazards.

Type 1 diabetes and pregnancy

Pregnancy in women with type 1 diabetes remains a challenge for the patient and healthcare team alike. The scenario box on this page highlights some of the problems in achieving...

Concomitant Analysis of Salivary Tumor Markers—A New Diagnostic Tool for Oral Cancer

Oral squamous cell carcinoma (OSCC) is a common human malignancy. Circulatory epithelial tumor markers were previously investigated in the serum of OSCC patients but almost never in their saliva, in spite of the fact that there is a direct contact between the saliva and the oral cancer lesion. The purpose of the current study was to examine tumor markers in the saliva of OSCC patients. We measured the concentrations of the six most studied epithelial serum circulatory tumor markers in the saliva of OSCC (tongue) patients. Significant increases (of 400%) in salivary concentrations of Cyfra 21-1, tissue polypeptide antigen, and CA125 were shown. Salivary concentrations of CA19-9, SCC, and carcinoembryonic antigen were increased without statistical significance. A concurrent analysis of the three significantly increased markers revealed sensitivity, specificity, and negative and positive predictive values of 71%, 75%, 71%, and 75%, respectively. The increase reported in salivary tumor markers may be used as a diagnostic tool, especially when a concurrent analysis for significantly increased markers is done. Salivary testing is noninvasive, making it an attractive, effective alternative to serum testing, and the possibility of developing home testing kits would further facilitate it as a diagnostic aid, enabling patients to monitor their own health at home and is important for those who live far from their treatment centers and especially for those at risk of developing OSCC.

Sexual health experts welcome use of home testing kits for STIs

Home testing kits for gonorrhoea, syphilis and Chlamydia are being trialled as part of a project that could transform sexual health screening.

Increased Use of Colorectal Cancer Tests

Increased Use of Colorectal Cancer Tests

Repeat chlamydia screening by mail, San Francisco

Objectives: To assess the feasibility and acceptability of home screening for repeat chlamydial infection using urine test kits sent through the mail. Methods: A letter offering home rescreening was mailed...