Study Objectives:

The primary aim of this study is to evaluate the sensitivity and specificity of the Abbot ANC panel and its usability by trained Healthcare Professionals in a non-laboratory setting.

Specific Objectives                                     

To evaluate the:

1. Sensitivity and specificity of the ANC panel

2. Usability of ANC panel in non-lab settings conducted by Healthcare Professionals

3. Operator’s understanding of the overall ANC panel test procedure

Study Design:

The first step will be to perform method validation on the individual test kits. 20 confirmed positive and 20 confirmed negative samples/panels will be used to determine the performance characteristics of the following;

•          Determine™ HIV Early Detect

•          Determine™ HBsAg 2

•          Determine™ Syphilis TP

The performance of qualitative tests will be described in terms of Sensitivity, Specificity and Percentage Agreement. The calculated results will be compared to manufacturer’s stated claims for Sensitivity, Specificity and Agreement found in the test kit package inserts during the validation process.

Study population and Size:

• Pregnant women 
• 18 years old or older
• Lives around Gaborone

The total required sample size for the Antenatal Care Panel to ensure the Usability requirements are met is N= 30 operators, each operator running one test one time.

Empirical data* suggests that a sample size of N=30 will find 99% of problems in a population (minimum of 97%).

For further validation of the ANC panel, confirmed HBsAg positive and negative archived plasma samples available will be used and results will be expected to remain the same. Similarly, both HIV positive and negative archived plasma samples will be used.

Study duration: 12 Months

Study Results: Study is on-going and no data analyses have been done yet

Sponsor: Abbott Rapid Diagnostics Pty

Principal Investigator: Motswedi Anderson, PhD