SAGE IVD recommended including the ABO blood groups and Rh factor typing test category in EDL 4
• as a general IVD for use in community settings and health facilities without laboratories (EDL 4, Section I.a);
• using a POC test format;
• using capillary whole blood as specimen type;
• to determine ABO groups and Rh factor. The group also noted that detection of the weak D antigen appears to be a limitation.

The ABO blood groups and Rh typing test is a straightforward, easy-to-use POC test for determining ABO groups and Rh. The test is very important in the context of maternal health care, in particular when laboratory-based tests are unavailable. Several SAGE IVD members would have preferred a little more data on the impact of the test on clinical outcomes. The group noted that in the case of strong D antigen expression, concordance is reported to be 99.9%; performance in the case of weak D antigen expression is somewhat lower. One SAGE IVD member reported 100% concordance based on literature he consulted, although minor variants in ABO were not detected. The experts proposed changing the title as submitted – “A, B and O blood groups and Rhesus (Rh) factor POC dry format card" – to “ABO blood groups and Rhesus factor typing point-of-care test” to be consistent with the way the test is reported in the literature. SAGE IVD made special note of the problem of weak D detection because it will have an impact on implementation. Literature cited in the discussion: Ravichandran S, Abraham P, Sugendran K, Hedegaard HO, Jones E. Trial and evaluation of dry format Eldon card for ABO & Rh blood grouping – “a new card concept”. Natl J Basic Med Sci. 2016;6(4):168–71.

POC dry cards are a simple-to-use, cheap and easy-to-implement test. They aim to diagnose a severe condition which can have a significant impact on the lives of a large group of unborn children and their parents. Treatment for this condition appears to be effective. The test requires limited infrastructure, facilities and training. The stability of samples is described in detail in technical documents. Documentation provided on diagnostic accuracy (e.g. sensitivity, specificity) in a real-world setting by untrained personnel is limited and of low quality. Nonetheless, given the clear effect (100% sensitivity and specificity) and the link with indirect evidence on concordance with laboratory tests (in a research setting), there is little reason to doubt the accuracy of this test. This is underpinned by the recommendation of several international guidelines. Although the impact on clinical outcomes was not demonstrated using empirical studies (as is the case with the majority of diagnostic tests), the alternative of not providing this test would have severe consequences for a large group of unborn children and their parents. Given the anticipated costs of US$ 1, minimal investment in supporting infrastructure and training, and the severity of the condition if left undetected and untreated, POC cards are expected to have a net positive cost–effectiveness. The availability of treatment, however, is a prerequisite for the IVD test to have any meaningful clinical impact. If availability is ensured, adopting the POC dry format card on the list would be recommended.

World Health Organization. (‎2023)‎. The selection and use of essential in vitro diagnostics: report of the fourth meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2022 (‎including the fourth WHO model list of essential in vitro diagnostics)‎. World Health Organization. https://iris.who.int/handle/10665/373322