https://orcid.org/0000-0003-3371-7246
References
- Tone, A. Medicalizing Reproduction: The Pill and Home Pregnancy Tests. J Sex Res 2012, 49(4), 319–327. DOI: 10.1080/00224499.2012.688226.
- Haarburger, D.; Pillay, T. S. Historical Perspectives in Diagnostic Clinical Pathology: Development of the Pregnancy Test. J. Clin. Pathol. 2011, 64(6), 546–548. DOI: 10.1136/jcp.2011.090332.
- Gnoth, C.; Johnson, S. Strips of Hope: Accuracy of Home Pregnancy Tests and New Developments. Geburtshilfe Frauenheilkd 2014, 74(7), 661–669. DOI: 10.1055/s-00000020.
- Swaminathan, N.; Bahl, O. P. Dissociation and Recombination of the Subunits of Human Chorionic Gonadotropin. Biochem. Biophys. Res. Commun. 1970, 40(2), 422–427. DOI: 10.1016/0006-291X(70)91026-0.
- Zegers-Hochschild, F.; Altieri, E.; Fabres, C.; Fernandez, E.; Mackenna, A.; Orihuela, P. Predictive Value of Human Chorionic Gonadotrophin in the Outcome of Early Pregnancy after In-Vitro Fertilization and Spontaneous Conception. Hum. Reprod. 1994, 9(8), 1550–1555. DOI: 10.1093/oxfordjournals.humrep.a138747.
- Stewart, B. K.; Nazar-Stewart, V.; Toivola, B. Biochemical Discrimination of Pathologic Pregnancy from Early, Normal Intrauterine Gestation in Symptomatic Patients. Am. J. Clin. Pathol. 1995, 103(4), 386–390. DOI: 10.1093/ajcp/103.2.123.
- Johnson, S. R.; Miro, F.; Barrett, S.; Ellis, J. E. Levels of Urinary Human Chorionic Gonadotrophin (hCG) following Conception and Variability of Menstrual Cycle Length in a Cohort of Women Attempting to Conceive. Curr. Med. Res. Opin. 2009, 25(3), 741–748. DOI: 10.1185/03007990902743935.
- Johnson, S.; Eapen, S.; Smith, P.; Warren, G.; Zinaman, M. Significance of Pregnancy Test False Negative Results Due to Elevated Levels of Beta-Core Fragment Hcg. J. Immunoassay Immunochem. 2017, 38(4), 449–455. DOI: 10.1080/15321819.2017.1329152.
- Scolaro, K. L.; Lloyd, K. B.; Helms, K. L. Devices for Home Evaluation of Women’s Health Concerns. Am J Health Syst Pharm 2008, 65(4), 299–314. DOI: 10.2146/ajhp070087.
- Bastian, L. A.; Nanda, K.; Hasselblad, V.; Simel, D. L. Diagnostic Efficiency of Home Pregnancy Test Kits. A Meta-analysis. Arch. Fam. Med. 1998, 7(5), 465–469. DOI: 10.1001/archfami.7.5.465.
- Pike, J.; Godbert, S.; Johnson, S. Comparison of Volunteers’ Experience of Using, and Accuracy of Reading, Different Types of Home Pregnancy Test Formats. Expert Opin. Med. Diagn. 2013, 7(5), 435–441. DOI: 10.1517/17530059.2013.830103.
- FDA. Medical Devices: Pregnancy. 2019. https://www.fda.gov/medicaldevices/productsandmedicalprocedures/invitrodiagnostics/homeusetests/ucm126067.htm,2019.
- Union OJotE. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017. 2017. https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32017R0745&from=EN (accessed Feb, 2019).
- BSI, A. Guide to the in Vitro Diagnostic Directive, 2012, pp 1–8.
- MHRA. An Introductory Guide to the Medical Device Regulation (MDR) and the in vitro Diagnostic Medical Device Regulation (IVDR), 2017
- SÜD T. TÜV SÜD: A Guide to the in Vitro Diagnostic Directive. 2019. https://www.tuv-sud.co.uk/uk-en/industry/healthcare-medical-devices/market-approval-certification/eu-market-access/eu-in-vitro-diagnostic-medical-device-regulation/faqs-in-vitro-diagnostic-medical-device-regulation-ivdr,2019.
- Johnson, S.; Cushion, M.; Bond, S.; Godbert, S.; Pike, J. Comparison of Analytical Sensitivity and Women’s Interpretation of Home Pregnancy Tests. Clin. Chem. Lab. Med. 2015, 53(3), 391–402. DOI: 10.1515/cclm-2014-0643.