| Literature DB >> 35664625 |
Samantha L Huey1, Jesse T Krisher1, David Morgan2, Penjani Mkambula2, Balaji Srinivasan1, Bryan M Gannon1, Mduduzi N N Mbuya3, Saurabh Mehta1,4.
Abstract
Vitamin A (VA) deficiency continues to be a major global health issue, despite measures to increase VA intake via consumption of staple foods such as edible oil. Portable quantitative and semiquantitative devices or test kits for internal quality control have the potential to overcome some of the limitations of traditional methods of testing, such as centralized laboratory, expensive equipment, and specially trained staff. This landscape analysis and comprehensive systematic mini-review catalogs and summarizes evidence on the analytical performance of portable quantitative and semiquantitative devices and test kits for the analysis of VA in edible oil. Studies or reports detailing the usability and validation of portable devices and/or test kits, as well as studies comparing device/test kit performance to a reference standard such as high-performance liquid chromatography (HPLC), were included. Identified devices and test kits were compared for performance versus the reference standard, usability, availability, and other characteristics. We identified four portable methods: two devices, the iCheck CHROMA and iCheck Chroma 3 from BioAnalyt; and two test kits, the QuickView from Bagco Enterprises and the Strategic Alliance for the Fortification of Vegetable Oils (SAFO) Test Kit by Badische Anilin and Soda Fabrik (BASF). Included studies reported the following: an internal validation of the portable method, a comparison of the portable method against a reference standard, a comparison of the portable method against another portable method, and several videos and company websites, which detailed device characteristics. iCheck CHROMA and QuickView quantified VA concentrations with high accuracy and precision compared to the reference standard for field-based quantification, were user-friendly, and provided results within 5 min. iCheck Chroma 3 requires more robust validation against a reference standard. We did not find data on internal validation or comparison against a reference standard for the current version of the SAFO test. Compared to QuickView and SAFO, the iCheck devices can transfer results to a hard drive or the Web, have an online order form for purchase, and meet a minimal set of criteria for point-of-need devices. iCheck, QuickView, and SAFO can quantify VA concentrations in the edible oils tested and determine whether a fortified oil meets country standards. Additional research is needed to validate these devices and test kits across additional oil types and document the ability to meet the minimal criteria for point-of-need devices suggested in this mini-review. Validation against a reference standard is required for SAFO. The limited number of portable methods available may be due to market saturation. Future market and use case analyses to inform the market size and utility of the different tests with publicly available data will allow new manufacturers, particularly those in lower-to-middle-income countries, to enter the market.Entities:
Year: 2022 PMID: 35664625 PMCID: PMC9161250 DOI: 10.1021/acsomega.1c07181
Source DB: PubMed Journal: ACS Omega ISSN: 2470-1343
Figure 1PRISMA[2] diagram for study identification and screening. Adapted from the PRISMA Statement.
Device or Test Kit Characteristics: Affordability, Reagents Needed, Portability, Testable Oils, and Global Availabilitya
| reagents | ||||||||
|---|---|---|---|---|---|---|---|---|
| device/kit; no. tests per kit | costs | requirements | procurement; storage conditions and shelf life | device: portability; maintenance; other attributes | device/test kit: storage conditions and shelf life | acceptable oils | determines vitamin A levels around national fortification target level | manufacturer support available; global availability |
| iCheck CHROMA and iCheck Chroma 3; | device $6,730, test kit $800; $8.00 per test (on basis of test kit) | iEX ELAN disposable reaction vial, containing SbCl3 and CHCl3, 1 mL syringes, 0.8 mm × 16 mm needles | included in kit; 20–30 °C, no direct sunlight, upright; shelf life 12 months (10 million measurements possible) | portable (0.45 kg, 11 × 4 × 20 cm) with handle for carrying; NR; batteries are required | 12 months at 25 °C; autocontrol to verify function of emitter and receptor | palm, soy, cottonseed, | yes | website, email address, phone number and address; order directly from website; used in >80 countries and shippable globally |
| ++ | +++ | +++ | +++ | +++ | ++ | +++ | +++ | |
| QuickView; | unclear if available for purchase | dropper, larger tubes (chloroform), smaller tubes (SbCl3), wire stirrer, instructions with color chart, tissue paper for breaking glass tubes safely | included in kit; NR | portable (dimensions and weight NR but appears small and lightweight); NR | NR | coconut, other light-colored cooking
oils | yes | unclear; contact information includes phone number, address, and email address, but email appears inactive since 2016; no indication on how to order |
| + | ++ | ++ | +++ | ++ | ++ | +++ | + | |
| SAFO, | pricing not published; estimated $0.05–$0.10 per test | water, dichloromethane, trichloroacetic acid, copper sulfate, ascorbic acid; sample of unfortified oil | included in kit; reagent (dichloromethane + trichloroacetic acid) cannot be exposed to >40 °C | portable (dimensions and weight NR; described as size of a laptop); NR; color-coded vials, jars, pipets | NR | sunflower, | yes but must know target concentration in advance | website, contact form on website; yes |
| +++ | ++ | +++ | ++ | + | ++ | ++ | ++ | |
| HPLC coupled UV–vis[ | $20,000–$50,000 per machine; $50–$100 per test | methanol, ethyl acetate, and isopropanol | purchase separately; depends on reagent | not portable; requires routine maintenance; NR | controlled conditions | palm, rapeseed, soy, coconut, and vegetable (unspecified) | yes | depends on manufacturer; yes |
| + | ++ | ++ | + | + | +++ | +++ | +++ | |
| GC coupled UV–vis or MS | $10,000–$50,000 per machine; $25–$40 per test | methanol, ethyl acetate, and isopropanol | purchase separately; depends on reagent | not portable; requires routine maintenance; can be used for different analyses or where procurement of vials is difficult | controlled conditions | NR | yes | depends on manufacturer; yes |
| + | ++ | ++ | ++ | + | + | +++ | +++ | |
| UV spectro-photometer[ | $1,000–$10,000; $7.50 per assay | dichloromethane, hexane | purchase separately; depends on reagent | not portable; requires routine maintenance | controlled conditions | not specified | yes | depends on manufacturer; yes |
| ++ | + | ++ | ++ | + | ++ | +++ | +++ | |
BASF, Badische Anilin and Soda Fabrik; GC, gas chromatography; GAIN, Global Alliance for Improved Nutrition; HKI, Hellen Keller International; IU, international units; MS, mass spectrometry; NR, not reported; ppm, parts per million; RE, retinol equivalents defined as 3.3 international units (IU) of vitamin A or as 1 μg; SAFO, Strategic Alliance for the Fortification of Oils and other Staple Foods; UNICEF, United Nations Children’s Fund; UV–vis, ultraviolet–visible detection; WFP, World Food Program.
Costs are approximate.
Published information cost per test, pricing not published, or proof-of-concept device/not commercially available.
Information extracted from company website and included studies in refs (3,8, 10a, 10b, and 23).
Not validated against a reference standard.
+, not acceptable; ++, acceptable; +++, best.
Information extracted from company website and included studies in refs (6, 12, and 21).
Information extracted from company website and included studies in refs (13 and 20a).
Tested, but not validated against a reference standard.
Device or Test Kit Characteristics: Ease of Use/User Friendlinessa
| device/kit | training needs | instructions | calibration steps | sample preparation | steps | overall time required | results interpretation | recording results |
|---|---|---|---|---|---|---|---|---|
| iCheck CHROMA and iCheck Chroma 3 | 1 h to <1 day training required | displays instructions at each step and company website includes
user guide, instructional videos | precalibrated during manufacture; test using standard before using | warm, if solid, to maximum 50 °C to liquefy | four to five steps (blank measurement, sample injection, reaction and measurement, result display) | <5 min | exact concentration output on device | downloadable data including sample no., batch no., result (in mg of RE/kg or IU/g), date, time |
| +++ | +++ | +++ | +++ | +++ | +++ | +++ | +++ | |
| QuickView | <1 day training required: requires breaking glass to access reagents and requires | organization website includes instructional video | no calibration indicated in written instructions or video | no sample preparation required (no instructions for solid oil samples) | six steps (break big glass tube, add oil, break small glass tube, transfer materials, mix, reaction, comparison) | <5 min | within range of 5 mg of RE/kg | visually assess blue color change to match five reference colors (equivalent to different vitamin A concentrations from 5–25 mg of RE/kg) |
| ++ | +++ | +++ | ++ | ++ | +++ | ++ | ++ | |
| SAFO | <1 day training and lab experience required: requires extensive measuring and pipetting; color coding of equipment may limit use by individuals who are color-blind | company website includes instructional video; user manual not found | CuSO4 standards preparation required | no sample preparation required (no instructions for solid oil samples) | ∼15 steps (see text); requires assumption of target vitamin A fortification level | <5 to 20 min, depending on training level | below, at, or above assumed target level | visually assess blue color change to match three reference colors, equivalent to being below, at, or above target fortification standard from light (below target), medium (target), or dark (higher than target) |
| ++ | ++ | ++ | ++ | + | ++ | + | + | |
| HPLC coupled UV–vis[ | requires training from manufacturers, short courses, etc. | device manual available; various videos available | multiple-step flow rate calibration required | dilution with low-boiling solvent to fall in range of 1–30 mg/kg, homogenization, filtering | ≥6 steps (dilution, homogenization, filtration, mobile phase, comparison to reference, washing) | ≥65 min | exact concentration output on attached computer | chromatogram with quantified absorbance for vitamin A concentration |
| + | +++ | + | + | ++ | + | ++ | ++ | |
| GC coupled UV–vis or MS | requires training from manufacturers, short courses, etc. | device manual available; various videos available | validate gas flow against predefined acceptance criteria, run dilutions, plot response times vs concentrations, construct calibration curves | dilution with low-boiling solvent, dissolve | four steps (sample dilution, dissolution, injection; ionization, filtration, detection) | ≤60 min | exact concentration output on attached computer | chromatogram with quantified absorbance for vitamin A concentration |
| + | +++ | ++ | + | +++ | + | ++ | ++ | |
| UV spectrophotometer[ | <1 day training and lab experience required | device manual available; various videos available | frequent calibration following manufacturer instructions to confirm calibration of monochromator | dilute sample in organic solvents; require blanks | eight steps (sample preparation, mixing, recording, correct absorbance rating, estimation) | ∼20 min | exact concentration output on attached computer | absorption spectrum with quantified absorbance for vitamin A concentration |
| ++ | +++ | + | + | ++ | +++ | ++ | ++ |
BASF, Badische Anilin and Soda Fabrik; GC, gas chromatography; GAIN, Global Alliance for Improved Nutrition; HKI, Hellen Keller International; IU, international units; MS, mass spectrometry; NR, not reported; ppm, parts per million; RE, retinol equivalents defined as 3.3 international units (IU) of vitamin A or as 1 μg; SAFO, Strategic Alliance for the Fortification of Oils and other Staple Foods; UNICEF, United Nations Children’s Fund; UV–vis, ultraviolet–visible detection; WFP, World Food Program.
Information extracted from company website and included studies in refs (3, 8, 10a, 10b, and 23).
iCheck Chroma: Self-training video: https://www.youtube.com/watch?v=v69kttryFOo.
iCheck Chroma 3: How to control your device, 1/2: https://www.youtube.com/watch?v=zeCOdh8IqUs.
iCheck Chroma 3: How to measure your sample, 2/2. https://www.youtube.com/watch?v=s2Kyg90qyz0.
+, not acceptable; ++, acceptable; +++, best.
Information extracted from company website and included studies in refs (6, 12, and 21).
QuickView instructional video: http://bagcoent.com/gallery/videos/Quick%20View%20Instructional%20Video.mp4.
Information extracted from company website and included studies in refs (13 and 20a).
Description of Included Studies Validating the Portable Method and/or Comparing against a Reference Standarda
| author year; report type | device | manufacturer | oil sample tested | source of oil sample | test location (field/lab, country) | fortification standard described/noted | reference method | ref |
|---|---|---|---|---|---|---|---|---|
| Bullecer 2016; | iCheck CHROMA | Bioanalyt GmbH | coconut | commercial | NR (Philippines) | Philippine Food Fortification Law: 12–23 mg of RE/kg | HPLC | ( |
| Makhumula 2016; conference proceedings | iCheck Chroma 3 | Bioanalyt GmbH | vegetable oil (unspecified) | commercial | NR (Uganda) | Uganda: 25 mg of RE/kg | UV-S | ( |
| Maramag 2016 and Castro 2016; | QuickView | Bagco Enterprises | coconut | commercial | NR (Philippines) | Philippine Food Fortification Law: 12–23 mg of RE/kg | HPLC | ( |
| NCP 2016; | iCheck CHROMA | Bioanalyt GmbH | coconut | commercial | NR (Philippines) | Philippine Food Fortification Law: 12–23 mg of RE/kg | HPLC | ( |
| QuickView | Bagco Enterprises | coconut | commercial | NR (Philippines) | Philippine Food Fortification Law: 12–23 mg of RE/kg | HPLC | ( | |
| Renaud 2013; journal | iCheck CHROMA | Bioanalyt GmbH | rapeseed, soy, groundnut | commercial | NR (France) | N/A | HPLC, UV/vis | ( |
| Rohner 2011; journal | iCheck CHROMA | Bioanalyt GmbH | palm | households/commercial | field (Côte d’Ivoire); laboratory (Germany) | Côte d’Ivoire: 6.4–9.6 mg of RE/kg, i.e., 8 mg of RE retinyl palmitate/kg of oil | HPLC, UV/vis | ( |
| GAIN 2018; coutnry survey | iCheck Chroma 3 | Bioanalyt GmbH | sunflower, cotton, palm olein, palm, soybean, vegetable, rapeseed, corn, blended, peanut, red palm | commercial | Burkina Faso | 11–24 mg of RE/kg | none | ( |
| BioAnalyt 2020; company report (internal data) | iCheck Chroma 3 | Bioanalyt GmbH | soy | NR | NR | N/A | none | ( |
HPLC, high performance liquid chromatography; NCP, Nutrition Center of the Philippines; NR, not reported; RE, retinol equivalents defined as 3.3 international units (IU) of vitamin A or as 1 μg; UV-S, ultraviolet spectrophotometry.
NCP reported the same QuickView and iCheck validation studies that were also reported by Bullecer et al.,[4] Maramag et al.,[12] and Castro et al.[11] Maramag et al.[12] and Castro et al.[11] are the same report: the former is posted on the company website and the latter was accepted at the Micronutrient Forum 2016 conference.
Assessment of Devices and Test Kitsa against Manufacturer-Reported Performance, by ASSUREDb Criteriae
Only studies that mention any of the ASSURED criteria are included.
ASSURED criteria have been adapted from ref (24).
Ranges are given as 95% confidence intervals.
“Corrected” sensitivity: iCheck values were corrected by subtracting the mean difference between iCheck and HPLC from the actual reading.
HPLC, high-performance liquid chromatography; n/a, not available; NR, not reported; RE, retinol equivalents. Green = matches stated criteria; yellow = somewhat matches stated criteria; red = completely different between manufacturer’s stated criteria and study reporting.
iCheck CHROMA: Device Performance for Palm, Rapeseed, and Groundnut Oilsa
| palm oil[ | rapeseed oil[ | groundnut oil[ | |||||
|---|---|---|---|---|---|---|---|
| validation | index 1 | index 1 | validation | index 1 vs reference | validation | index 1 vs reference | |
| validation of portable device | |||||||
| no. samples | 200 | 189 | 200 | 15 | 15 | 15 | 15 |
| 0.996, Spearman | 0.92, Spearman | 0.94, Spearman | NR | 0.981 | NR | 0.988 | |
| regression equation | |||||||
| vitamin A concn levels tested (mg of RE/kg); replicates | 2.8, 5.6, 6.5, | 3.0, 7.5, 15.0, 22.5, 30.0; 3 | 3.0, 7.5, 15.0, 30.0; 5 | 3.0, 7.5, 15.0, 22.5, 30.0; 3 | 3.0, 7.5, 15.0, 30.0; 5 | ||
| operational range (mg of RE/kg) (LODlow to LODhigh) | 2.5–30 | 0–16 | 0–16 | 3–15 | 3–15 | ||
| accuracy | N/A | 0.1% difference in adequately fortified samples | N/A | RMSE: index 1 = 3.99; reference = 0.61 | N/A | RMSE: index 1 = 5.49; reference = 2.25 | |
| precision | |||||||
| intra-assay % CV | 3.2–7.1%; 1.7–10.6% | 8.6%; 2.1% | 7.0; 1.8% | ||||
| interassay % CV | 1.4–8.8%; 0.2–3.3% | ||||||
| interobserver % CV | 3.8–4.8%; 1.1–3.9% | ||||||
| Bland–Altman mean bias LOA or mean difference for portable device (mg of RE/kg) | LOAlow = −1.24; LOAhigh = 2.53 | LOAlow = 0.60; LOAhigh = 1.99 | mean difference: ∼3 | mean difference: ∼4.5 | |||
LOA, limits of agreement, calculated as Δ – 2s = LOAlow and Δ + 2s = LOAhigh, where Δ is the mean of the difference between the two methods and s is the standard deviation of this difference. LOD, limit of detection, where LODlow is the lowest concentration of detection and LODhighis the maximum concentration of detection. NR, not reported; RE, retinol equivalents defined as 3.3 international units (IU) of vitamin A or as 1 μg; RMSE, root mean squared error.
Portable test in Germany (laboratory setting).
Reference test in Germany (laboratory setting).
Reference test is HPLC.
Portable test in Côte d’Ivoire (field setting).
At vitamin A concentrations of 3 and 15 mg of RE/kg, respectively.
Coefficient of determination.
These concentrations and accompanying results were measured by AOAC;[5] nonsuperscripted concentrations were only included in Rohner et al.[3a]
QuickView: Device Performancea
| coconut oil[ | ||
|---|---|---|
| validation | index 1 vs reference | |
| validation of portable device | ||
| no. samples | 100 | NR |
| NR | 0.66, NR | |
| regression equation | NR | |
| vitamin A concn levels tested (mg of RE/kg); replicates | 5, 10, 15, 20, 25; NR | 5, 10, 15, 20, 25; NR |
| operational range (mg of RE/kg) (LODlow to LODhigh) | NR | NR |
| accuracy | N/A | |
| precision | ||
| intra-assay % CV | ||
| interassay % CV | ||
| interobserver % CV | ||
| Bland–Altman mean bias LOA or mean difference for portable device (mg of RE/kg) | mean difference: −4.036 | |
Notes: LOA, limits of agreement, calculated as Δ – 2s = LOAlow; Δ + 2s = LOAhigh where Δis the mean of the difference between the two methods and s is the standard deviation of this difference. LOD, limit of detection, where LODlow is the lowest concentration of detection and LODhigh is the maximum concentration of detection; NR, not reported; RE, retinol equivalents defined as 3.3 international units (IU) of vitamin A or as 1 μg.
Reference test is HPLC.
While a sample size of 100 was given, it is unclear if this was the total sample size (50 samples per QuickView, 50 samples per HPLC) or 100 samples per each method.
iCheck CHROMA: Device Performance for Soy and Coconut Oilsa
| soy oil[ | coconut oil[ | |||
|---|---|---|---|---|
| validation | index 1 vs reference | validation | index 1 vs reference | |
| validation of portable device | ||||
| no. samples | 15 | 15 | 100 | NR |
| NR | 0.983 | NR | NR | |
| regression equation | NR | NR | ||
| vitamin A concn levels tested (mg of RE/kg); replicates | 3.0, 7.5, 15.0, 22.5, 30.0; 3 | 3.0, 7.5, 15.0, 30.0; 5 | 5, 10, 15, 20, 25; NR | NR; NR |
| operational range (mg of RE/kg) (LODlow to LODhigh) | 4–15 | 5–27.8 | ||
| accuracy | N/A | RMSE: index 1 = 4.91; reference = 0.40 | N/A | |
| precision | ||||
| intra-assay % CV | NR; | |||
| interassay % CV | 3.5–7.3% | |||
| interobserver % CV | 1.3–14.7% | |||
| Bland–Altman mean bias LOA or mean difference for portable device (mg of RE/kg) | mean difference: ∼ –4 | mean difference: 1.9 ± 2.3 (95% CI: −2.6, 6.5) | ||
LOA, limits of agreement, calculated as Δ – 2s = LOAlow and Δ + 2s = LOAhigh, where Δ is the mean of the difference between the two methods and s is the standard deviation of this difference. LOD, limit of detection, where LODlow is the lowest concentration of detection and LODhigh is the maximum concentration of detection. NR, not reported; RE, retinol equivalents defined as 3.3 international units (IU) of vitamin A or as 1 μg; RMSE, root mean squared error.
Reference test is HPLC.
Coefficient of determination.
While a sample size of 100 was given, it is unclear if this was the total sample size (50 samples per iCheck, 50 samples per HPLC) or 100 samples per each method.
Not reported because LOD for soy oil is >3 mg of RE/kg.
At vitamin A concentrations of 3 and 15 mg of RE/kg, respectively.
iCheck Chroma 3: Device Performancea
| vegetable (unspecified) oil[ | ||||
|---|---|---|---|---|
| validation | index 1 vs reference | soy oil[ | cooking oil, | |
| validation of portable device | ||||
| no. samples | 10 | 10 | NR | 214 (pooled to 91 composite samples) |
| NR | NR | 0.97, NR | NR | |
| regression equation | NR | NR | NR; duplicates times 4 | |
| vitamin A concn levels tested (mg of RE/kg); replicates | average concn: 17 ± 0.5; 10 | average concn: | 3–30 | |
| operational range (mg of RE/kg) (LODlow to LODhigh) | NR | NR | 0–30 | NR |
| accuracy | N/A | N/A | N/A | |
| precision | ||||
| intra-assay % CV | 3% | NR | 0.9–2.7% | |
| interassay % CV | NR | NR | ||
| interobserver % CV | NR | NR | ||
| Bland–Altman mean bias LOA or mean difference for portable device (mg of RE/kg) | not done | |||
LOA, limits of agreement, calculated as Δ – 2s = LOAlow and Δ + 2s = LOAhigh, where Δ is the mean of the difference between the two methods and s is the standard deviation of this difference. LOD, limit of detection, where LODlow is the lowest concentration of detection and LODhigh is the maximum concentration of detection. NR, not reported; RE, retinol equivalents defined as 3.3 international units (IU) of vitamin A or as 1 μg.
Reference test is HPLC.
Including some or all of the following:[9] sunflower, cotton, palm olein, palm, soybean, vegetable, rapeseed, corn, blended, peanut, red palm.
Reference test is UV-S.
Coefficient of variation: unclear if intra-assay, interassay, or interobserver.
Figure 2Minimal set of criteria for point-of-need devices.
Figure 3Exploded view of the portable spectrophotometer with a 3D printed casing for housing the various components. Created with BioRender.com.
Figure 4(a) Screenshots of the mobile app. (b) Sample processing steps involved in quantification of vitamin A in oil samples on the portable spectrophotometer device. Created with BioRender.com.
Figure 5Schematic summarizing the various performance parameters to be optimized and performance characterization plots for portable spectrophotometer. Created with BioRender.com.
Figure 6Validation of portable spectrophotometer against a reference method and statistical analysis to determine acceptability for a target vitamin A quantification application. Created with BioRender.com.