Table 4.

Representative commercially available technologies available to diagnose the leading causes of neonatal mortality. Notably, many of the listed technologies are lacking robust usability, scalability, and field performance studies.

Condition	Representative Technology	Analyte Measured	Core Technology	Sample Purity	Diagnostic Performance	Cost	Power*	Health System Use Level	Advantages	Limitations	Image
Hypothermia	ThermoSpot252,254	Body Temperature	Trans-cutaneous Sensor	N/A	Sensitivity: 88% Specificity: 97% † 252	$0.11	None	Health Post	Low cost; minimal training requirements; noninvasive	Can fall off of neonate; only provides temperature range
Jaundice	BiliChek393–395	Bilirubin	Trans-cutaneous Optical Sensor	N/A	R2=0.86 When TSB > 14 mg/dL: AUC: 0.95 95% CI: 0.92–0.97 † 393	$3,900 instrument $7/test	Low	Health Center	Noninvasive	High cost; may require additional confirmatory lab tests
Hypoglycemia	Nova StatStrip276,396	Glucose	Lateral Flow with Reader	Whole Blood	Sensitivity: 90–100% Specificity: 97.7–99.4% † 276	$250 instrument $0.30/test	Low	Health Post	Accurate with neonatal samples; integrated sample preparation	Higher instrument cost than other glucometers
Birth Asphyxia	Moyo301,397	Fetal Heart Rate	Trans-cutaneous Doppler Sensor	N/A	Accuracy: +/−5 bpm in the range of 50–200 bpm†† 301	$198	Low	Heatlh Center	Noninvasive; portable	Not as sensitive for asphyxia as gold standard
Sepsis	Blood Culture388–391	Bacterial Load	Laboratory Microbiology	Sterile Whole Blood	Sensitivity: 73% † 388	$28	High	Reference Lab		Prone to contamination and false positives
HIV	Alere™ q HIV-1/2 Detect328,398	HIV RNA	Automated Microbiology Analyzer	Whole Blood	Sensitivity: 99.3%, Specificity: 100.0% † 328	$25,000 instrument, $25.00/test	Mod	Reference Lab	High diagnostic performance; integrated sample preparation	Maximum of 8 samples per day, high cost
Congenital Syphilis	SD Bioline Syphilis 3.0344,399,400	Antibodies to Treponema pallidum	Lateral Flow	Whole Blood	Sensitivity: 84.5% Specificity: 97.9% † 344	$0.90	Low	Health Post	Low-cost; minimal training requirements, results in 20 minutes	Only used to diagnose mother during pregnancy
Pneumonia	Counting Beads321	Respiratory Rate	Clinical Observation	N/A	Sensitivity for fast breathing: 68% † 321	Provided by International Organizations	Low	Heatlh Post	Power-based equipment-free; minimal training requirements	Requires training and significant time by staff

^*Power can be battery based, with low indicating small, easily replaceable batteries, moderate indicating larger, more expensive batteries, and high indicating dependency on electrical power grid.

^†Reported diagnostic performance is idenpendently verified.

^††Diagnostic performance is manufacturer reported.

Hypothermia image reproduced from Reference 254 under the terms of Creative Commons Attribution License.

TBS: Total Serum Bilirubin

Jaundice provided courtesy of Philips.

Hypoglycemia image provided courtesy of Nova Biomedical.

Birth Asphyxia figure from Laerdal Global Hleath AS. All rights reserved.

Sepsis image reproduced from Reference 391 under the terms of Creative Commons Attribution License.

HIV image provided courtesy Alere Inc.

Congenital Syphilis image provided courtesy Alere Inc.

Pneumonia image reproduced from Reference 321 under the terms of Creative Commons Attribution License.