Potassium and more LIVD data

	A	B	C	D	E	F
1	Data elements collected/recorded by AdVeritas from package inserts	Definition	Equivalent to LIVD column	Equivalent to expanded APHL LIVD file	Comment	Column headers from
2	Done? (Y)	Entry ready for release - choices are: Not yet / Check / Ready / Ready - no notes / Ready (correction) / Ready* / Airtable / Y / N	Publication Version ID		this mapping for when test included in LIVD file - until then, this would be empty, corresponding to No
3	Company/Organization	Manufacturer name of the IVD test	Manufacturer
4	Test Name		Model		or Manufacturer Analyte Name?
5	*URL	publicly available URL to the test in the FDA table		Adveritas file	should probably also record when accessed, as we noticed, that sometimes URLs are reused!
6	Test Type (Lab or Kit)	indicates what the package insert refers to - choices are: Kit / Lab / Collection		Adveritas file
7	Country of Origin	manufacturer location		Adveritas file
8	US Regulatory Status	choices are: EUA granted / 510k / ???		Adveritas file
9	Category	Type of test - choices are: Lab / POCT / Home / Lab + POCT / Home + POCT		Adveritas file
10	Authorized Setting(s) per FDA	CLIA Complextity; multi-select allowed - choices are: H = high / M = medium/ W = waived / Home		Adveritas file
11	Authorized Settings			Expanded LIVD file in use by CDC
12	Technology	Category of technology used - choices are: antigen / molecular / serology		Adveritas file	check mapping
13	Test Type			Expanded LIVD file in use by CDC	check mapping
14	Analyte	Analyte detail - choices are: RNA / antigen / IgM / IgG / IgG/IgM / IgA/IgG/IgM		Adveritas file
15	Assay	type of test - choices are: rRT-PCR / Isothermal Amplification /Lateral Flow /Heterogeneous Immunoassay /Homogeneous Immunoassay /Heterogeneous Immunoassay (CLIA) /NGS /ELISA /qSTAR / RT-PCR, MALDI-TOF / TMA, DKA / DETECTR/ RT-LAMP		Adveritas file	check mapping
16	Vendor Method			Column header from LIDR group K+ file
17	Test Method			Expanded LIVD file in use by CDC	check mapping
18	Specimen Type	Allowed specimen types - choices are: NP swab / OP swab / ANs swab / MTNs swab / Ns swab / Sal / Spu / Ns aspirate / Ns wash / NP aspirate / NP wash / BAL / Ser / Pla / VWB	Vendor Specimen Description	Adveritas file
19	Transport Media	allowed transport media - choices are: NA / ND / VTM / UTM / Saline / VTM, Amies transport medium, saline		Adveritas file
20	Gene	target genes for molecular tests - choices are: NA / N / E / S / ORF1ab / N (N1, N2)		Adveritas file	assume multi-select is allowed
21	Antigen	AG targeted - choices are: NA / ND / N / S		Adveritas file
22	Sample Prep	describes sample preparation - choices are: NA = not applicable / Manual / descripton of process used and identification of instrument used, if applicable		Adveritas file
23	Detection	identifies the instrument used for detection	Equipment UID	Adveritas file
24	Detection	identifies the instrument used for detection	Equipment UID Type	Adveritas file
25	TAT	turn around time (free text)		Adveritas file
26	Analytical Sensitivity (LOD)	Level of detection		Adveritas file
27	LOD of FDA Reference Panel (NDU/mL)			Adveritas file
28	Cross- Reactivity	overall impression of reported cross-reactivity with other viruses		Adveritas file
29	PPA/Sensitivity			Adveritas file
30	PPA Sample Size			Adveritas file
31	PPA Specimen Type	identifies if just clinical samples or also pooled clinical samples were used		Adveritas file
32	NPA/Specificity			Adveritas file
33	NPA Sample Size			Adveritas file
34	NPV @ 5% prevalence			Adveritas file
35	PPV@ 5% prevalence			Adveritas file
36	Manufacturer's Validation Notes	free text		Adveritas file
37	External Quality Control	Choices are: Included / Excluded / NA = not applicable some free text added sometimes		Adveritas file
38	Process (internal) Control	Choices are: Included / Excluded / NA = not applicable some free text added sometimes		Adveritas file
39	Positive Control	Choices are: Included / Excluded / NA = not applicable some free text added sometimes		Adveritas file
40	*Publications	URL for cited article		Adveritas file
41	*IFU	URL for the package insert		Adveritas file
42	*Letter of Authorization (EUA)	URL for the EUA letter		Adveritas file
43	Creation Date	date listed on FDA website as date created		Adveritas file
44	Modified Date	date listed on FDA website as date modified		Adveritas file
45	Needs Review	Flag for internal work		Adveritas file
46	Vendor Analyte Name			LIVD specification column
47	Vendor Result Description - gets spilt into Scale, QL and QN representation			LIVD specification column
48	Test Performed LOINC Code			LIVD specification column
49	Test Performed LOINC Long Name			LIVD specification column
50	Test Ordered LOINC Code			LIVD specification column
51	Test Ordered LOINC Long Name			LIVD specification column
52	Vendor Comment			LIVD specification column
53	Vendor Analyte Code			LIVD specification column
54	Vendor Reference ID			LIVD specification column
55	Testkit Name ID			LIVD specification column
56	Testkit Name ID Type			LIVD specification column
57	LOINC Component			LIVD specification column
58	LOINC Property			LIVD specification column
59	LOINC Time			LIVD specification column
60	LOINC System			LIVD specification column
61	LOINC Scale			LIVD specification column
62	LOINC Method			LIVD specification column
63	LOINC Version ID			LIVD specification column
64	SORT / Row#			Column header from LIDR group K+ file
65	Harmonization Indicator			Column header from LIDR group K+ file
66	Clinical Context needed for mapping			Column header from LIDR group K+ file
67	Source of entry			Column header from LIDR group K+ file
68	Committee Reviewed			Column header from LIDR group K+ file
69	Vendor Reviewed			Column header from LIDR group K+ file
70	Standard name?			Column header from LIDR group K+ file
71	Result scale (QL Nar, QL Nom, QL ord, QN, semiQN)			Column header from LIDR group K+ file
72	Result Value Set (QL results)			Column header from LIDR group K+ file
73	Units of measure			Column header from LIDR group K+ file
74	Reference Range			Column header from LIDR group K+ file
75	Mapping Date			Column header from LIDR group K+ file
76	Generic Notes for any other information we get			Column header from LIDR group K+ file
77	All EUA Attributes	Combines all the listed FDA attributes in the FDA table - this list grew over time		Expanded LIVD file in use by CDC
78	Show All Serial Rows	Supports filtering on rows showing tests authorized for only for serial testing		Expanded LIVD file in use by CDC
79	Show All Screening Rows	Supports filtering on rows showing tests authorized for screening use		Expanded LIVD file in use by CDC
80	Show All Pooling Rows	Supports filtering on rows showing tests authorized for use on pooled specimen		Expanded LIVD file in use by CDC
81	Show All Home Testing Rows	Supports filtering on rows showing tests authorized for at home testing		Expanded LIVD file in use by CDC
82	Serial Testing			Expanded LIVD file in use by CDC
83	Screening			Expanded LIVD file in use by CDC
84	Serial Screening			Expanded LIVD file in use by CDC
85	Pooling			Expanded LIVD file in use by CDC
86	Pooled Serial Screening - Media			Expanded LIVD file in use by CDC
87	Pooled Serial Screening - Swab			Expanded LIVD file in use by CDC
88	Visual or Instrument Read	Indicates whether the result is produced by the instrument or create by visual read (applies to At-Home tests)		Expanded LIVD file in use by CDC
89	Qualitative or Quantitative Result	indicator for scale of the test		Expanded LIVD file in use by CDC
90	Single or Multiple Targets	Indicates if a PCR test targets a single gen or more than one gene		Expanded LIVD file in use by CDC
91	Multi-analyte	Test targets more than one organism (also known as mulit-plex		Expanded LIVD file in use by CDC
92	Saliva	Allows filtering on all tests allowed on saliva		Expanded LIVD file in use by CDC
93	Fingerstick	Allows blood collection via fingerstick method (capillary blood)		Expanded LIVD file in use by CDC
94	Direct to Consumer FDA designation (DTC)	Indicates that consumers can buy this test over the counter (testing is at a lab)		Expanded LIVD file in use by CDC
95	Home Collection	Documents home collection procedure (not necessarily an at-home test)		Expanded LIVD file in use by CDC
96	Collection Kit	Documents collection procedure		Expanded LIVD file in use by CDC
97	Non-prescription Testing	test does not require an order by a provider		Expanded LIVD file in use by CDC
98	Prescription Home Testing	Test requires an order by a provider, but then can be executed by consumer		Expanded LIVD file in use by CDC
99	Over the Counter (OTC) Home Testing	Test can be bought by consumer and used by consumer (not performed by lab professional)		Expanded LIVD file in use by CDC
100	Telehealth Proctor Supervised	At home testing under supervision		Expanded LIVD file in use by CDC