Study designs of evaluations included in the review
The studies were required to included appropriate (non-pregnant) controls and to report on a sample size greater than 20. Review articles were excluded.
Specific interventions included in the review
No inclusion criteria were specified for the type of HPT included. The following types of pregnancy testing kits were included: Ova 11, Predictor, Answer, Daisy 2, e.p.t., e.p.t. plus, Advance, Fact, Answer 2, First Response and Acu-test. The kits were used both at home and in a laboratory. One study was excluded because the HPT used in it was no longer available.
Reference standard test against which the new test was compared
The included studies were required to compare HPT to a reference standard of laboratory testing. The laboratory test and cut-off point used were not specified in the inclusion criteria.
Participants included in the review
No inclusion criteria were specified with respect to the study participants. Testers of kits included the following two groups: volunteers who performed the pregnancy tests on study samples obtained previously by the investigators; and female patients who collected their own urine samples according to the kit instructions and performed the pregnancy tests on their own samples.
Outcomes assessed in the review
The included studies were required to report sufficient data to enable the calculation of sensitivity and specificity values. Where necessary, attempts were made to contact authors to obtain this information. The calculated sensitivity, specificity and test effectiveness scores were used as outcomes.
How were decisions on the relevance of primary studies made?
The articles retrieved were reviewed by two of the authors. The methods used to resolve any disagreements were not stated.