Addendum 1a 2026 CONBS Testing Menu With Assays.xlsx

XLSX spreadsheet 37 KB Posted Oct 15, 2026

Attached to: NBS Laboratory Information Management System - OIT
Solicitation number: RFI FAAA 2027000011 2
Issued by: Denver County, Denver City, Colorado

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Written by GovTribe AI · Oct 21, 2026

This Addendum 1a document is a testing menu with assays for the 2026 Newborn Screening (NBS) Laboratory Information Management System contract with the State of Colorado, Office of Information Technology (OIT). The file provides a comprehensive list of assays and testing procedures that will be utilized within the NBS laboratory operations, detailing the specific laboratory tests and screening methodologies to be performed or supported by the contracted system. The addendum serves as an update to the original contract specifications, incorporating the expanded or revised testing protocols that align with current newborn screening standards and clinical requirements for 2026 operations.

The testing menu with assays represents the technical specifications and operational parameters for laboratory services delivery under the NBS Laboratory Information Management System contract. This addendum establishes the baseline testing capabilities, assay configurations, and laboratory procedures that the selected vendor's information management system must accommodate and support. The document functions as a binding attachment to the original contract solicitation, ensuring that all bidders understand the complete scope of testing services and laboratory operations that will be managed through the contracted information technology system for Colorado's newborn screening program.

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Other files

File	Type	Posted
Attachment 1 Vendor Information-Confirmation of Offer Form.docx	DOCX document	Oct 15, 2026
Addendum 1 Questions and Responses.pdf	PDF	Oct 15, 2026
Exhibit A LIMS Requirements.xlsx	XLSX spreadsheet	Oct 15, 2026
Exhibit B Budget Template.xlsx	XLSX spreadsheet	Oct 15, 2026
RFI 2027000011 NBS Laboratory Information Management System.pdf	PDF	Oct 15, 2026

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All Tests NEW QSight

		Disorder
Disorder Type	Disorder	Acronym	Disorder	Assay	Instrument	Primary Marker	Secondary Marker	Tertiarary Marker	Third Party Testing	Annual Estimated Testing Volume
Amino Acidemias				Revvity Neobase 2 Non-derivatized MSMS Kit with GAMT	Revvity QSight 210/225 MSMS System
	Phenylketonuria	PKU	Phenylketonuria			Phenylalanine	Phe/Tyr			75,000 samples
	Maple syrup urine disease	MSUD	Maple Syrup Urine Disease			Leucine/Isolucine	Leu/Phe
	Homocystinuria	MET	Homocystinuria			Methionine	Met/Phe
	Hypermethionemia	HCY
	Tyrosinemias	TYR I	Tyrosinemia Type 1			Succinyl Acetone (SA)	SA/Tyr
	Argenemia	ARG	Argininemia			Argenine	None
	Citrullinemia	CIT	Citrullinemia			Citrulline

ID#AAABA-CZeLo Gregory Bonn - CDPHE (2023-12-12 17:25:59)

washington has 2nd cut off	Cit/Arg
		Argininosuccinic acidemia	ASA
		Guanidinoacetate methyltransferase	GAMT	Guanidinoacetate methyltransferase			Guanidinoacetate (GUAC)	GUAC(1000)/Creatine
	Fatty Acid Oxidation Disorders				Revvity Neobase 2 Non-derivatized MSMS Kit with GAMT	Revvity QSight 210/225 MSMS System				75,000 samples
		Carnitine/Acylcarnitine translocase deficiency	CACT				C16	C18:1	C18
		Carnitine palmitoyl transferase type 1 (Birth)	CPT1				C0/C16+C18	C16
		Carnitine palmitoyl transferase deficiency	CPT2				C16	C0/(C16+C18)
		Carnitine Uptake Deficiency	CUD				C0	C3+C16	Acs*/Cit
		Long chain 3 hydroxy acyl-CoA dehydrogenase deficiency	LCHAD				C16OH	C18:1OH
		Medium chain acyl-CoA dehydrogenase deficiency	MCAD				C8	C8/C10	C10
		Short Chain Acyl-CoA dehydrogenase deficiency	SCAD				C4	C4/C3
		Trifunctional protein deficiency	TFP				C16OH	C16OH/C16
		Very long chain acyl-CoA dehydrogenase deficiency	VLCAD				C14:1

ID#AAABA-CZeLk Gregory Bonn - CDPHE (2023-12-12 17:25:41)

washington has a cut off for 2nds	C14:1/C16
	Organic Acidemias			Revvity Neobase 2 Non-derivatized MSMS Kit with GAMT	Revvity QSight 210/225 MSMS System
		Beta-Ketothiolase deficiency	BKT			C5:1	C5OH	75,000 samples
		Glutaric acidemia type 1	GA 1			C5DC

ID#AAABA-CZeL0 Gregory Bonn - CDPHE (2023-12-12 17:32:23)

check on age related cutoff	C5DC/C16
		Glutaric Acidemia Type II (aka Multiple acyl-CoA dehydrogenase deficiency)	GA 2	C4	C5
		3-Hydroxy 3-methyl glutaric aciduria	HMG	C6DC	C5OH
		aciduria
		Isovaleric acidemia	IVA	C5

ID#AAABA-CZeL4 Gregory Bonn - CDPHE (2023-12-12 17:32:56)

2nd screen cutoff? Washington has one	C5/C3
		Malonic Acidemia	MA	C3DC	C3DC/C10
		Multiple carboxylase deficiency	MCD	C5OH	C5OH/C8
		3-Methylcrotonyl CoA carboxylase deficiency	3MCC
		3 methylglutaconic aciduria	3MGA
		Propionic acidemia	PA	C3

ID#AAABA-CZeL8 Gregory Bonn - CDPHE (2023-12-12 17:33:38) washington has 2nd screen cutoff ID#AAABA-CZeLk Gregory Bonn - CDPHE (2023-12-12 17:25:41) washington has a cut off for 2nds ID#AAABA-CZeL0 Gregory Bonn - CDPHE (2023-12-12 17:32:23) check on age related cutoff ID#AAABA-CZeLo Gregory Bonn - CDPHE (2023-12-12 17:25:59)

washington has 2nd cut off	C3/C2
		Methylmalonic acidemia (mutase deficiency)	MUT
		Methylmalonic acidemia Cbl A,B	Cbl A,B
	Other								75,000 samples
		Biotinidase Deficiency	Biot	Biotinidase Deficiency	LDT Biochemical Assay	Colormetric/Manual	biotinidase		75,000 samples
		Cystic Fibrosis	CF	Cystic Fibrosis	Revvity GSP Neonatal IRT Kit	Revvity GSP Instrument	Immunoreactive Trypsinogen
					IDT xGen CFTR Amplicon Library Prep, extracted with QuantaBio Extracta DBS	Illumina (NextSeq 2k, Miseq, Miseq i100)	CFTR Gene	Additional cost over panel	1000 samples
		Galactosemia	GALT	Galactosemia	Revvity GSP Neonatal GALT Kit	Revvity GSP Instrument	Galactose -1-phosphate uridyl transferase		75,000 samples
		Severe Combine Immunodeficiency	SCID	Severe Combined Immunodeficiency	LDT Multiplexed with SMA/Modified Qiagen Generation Extraction	QuantStudio 12k Plus	TREC		75,000 samples
		Spinal Muscular Atrophy	SMA	Spinal Muscular Atrophy	LDT Multiplexed with SCID/Modified Qiagen Generation Extraction	QuantStudio 12k Plus	SMN1		75,000 samples
		X-Linked Adrenoleukodystrophy	X-ALD	X-Linked Adrenoleukodystrophy	Revvity Neobase 2 Non-derivatized MSMS Kit with GAMT	Revvity QSight 210/225 MSMS System	C26:0 LPC	Wisconsin / CONSP internal 2027	75,000 samples
		Congenital Cytomegalvirus	cCMV	Congenital CytomeglaVirus	LDT and Revvity NeoMDx cCMV PCR Kit/Modified Qiagen Generation Extraction	QuantStudio 12k Plus	CMV (IE2)		25,000 samples
	Endocrine
		Congenital Adrenal Hyperplasia	CAH	Congenital Adrenal Hyperplasia	Revvity GSP Neonatal CAH Kit	Revvity GSP Instrument	17-alpha hydroxy progesterone:		130,000 samples

	Congenital Hypothyroidsim	CH	Congenital Hypothyroidism	Revvity GSP Neonatal hTSH Kit	Revvity GSP Instrument	Thyroid Stimulating Hormone (TSH)	40,000 samples
				Revvity GSP Neonatal Thyroxine (T4) Kit	Revvity GSP Instrument	Thyroxine (T4)	130,000 samples
Hemoglobinopathies				Biorad VARIANTnbs Neonatal Chromatography Station/Second-tier IEF gel	Biorad VARIANTnbs Kit	Hemoglobin	75,000 samples
	Sickle Cell	HgB	Sickle Cell

Disease Cases (no A present) Disease Cases (no A present)

	Bart's (Hemoglobin H)		Bart's (Hemoglobin H)
Lysosomal Storage Disorders	Glycogen Storage Disease Type II		Pompe	LaCar Seeker Kit	LaCar SEEKER instrument	GAA	LaCAR sequencing	75,000 samples
	Mucopolysaccharidosis type I	MPSI	Mucopolysaccharidosis type I			IDUA	Mayo Testing for NREs /LaCAR sequencing
	Mucopolysaccharidosis type II	MPSII	Mucopolysaccharidosis type II	Revvity LDT 12/2026 currently being validated.	QSight 225	I2S		75,000 samples

Copy of All Tests NEW QSight

		Disorder
Disorder Type	Disorder	Acronym	Disorder	Assay	Instrument	Primary Marker	Conc umol/L or Ratio	Secondary Marker	Ratio or Conc umol/l	Tertiarary Marker
Amino Acidemias
	Phenylketonuria	PKU	Phenylketonuria	PKU		Phenylalanine	>= 100	Phe/Tyr	>= 2.5
	Maple syrup urine disease	MSUD	Maple Syrup Urine Disease	MSUD		Leucine/Isolucine	>= 230	Leu/Phe	>= 4.5
	Homocystinuria	MET	Homocystinuria	Met		Methionine	>= 33	Met/Phe	>= 1.0
	Hypermethionemia	HCY
	Tyrosinemias	TYR I	Tyrosinemia Type 1	TYR 1		Succinyl Acetone (SA)	>= 1.5	SA/Tyr	.0010--.0400 is normal
	Argenemia	ARG	Argininemia	Arg		Argenine	>= 100	None
	Citrullinemia	CIT	Citrullinemia	Cit		Citrulline	>= 50	Cit/Arg	>= 5.50
	Argininosuccinic acidemia	ASA
	Guanidinoacetate methyltransferase	GAMT	Guanidinoacetate methyltransferase	GAMT		Guanidinoacetate (GUAC)	>=10	GUAC(1000)/Creatine	>=30
Fatty Acid Oxidation Disorders
	Carnitine/Acylcarnitine translocase deficiency	CACT				C16	>= 9.9	C18:1	>= 2.43	C18	1.91
	Carnitine palmitoyl transferase type 1 (Birth)	CPT1				C0/C16+C18	>= 25	C16	<. 60
	Carnitine palmitoyl transferase deficiency	CPT2				C16	>= 9.9	C0/(C16+C18)	< 2.46
	Carnitine Uptake Deficiency	CUD				C0	< 9.5	C3+C16	< 2.2	Acs*/Cit	< 3.00
	Long chain 3 hydroxy acyl-CoA dehydrogenase deficiency	LCHAD				C16OH	>= 0.15	C18:1OH	>= 0.10
	Medium chain acyl-CoA dehydrogenase deficiency	MCAD				C8	>= 0.3	C8/C10	>= 2.00	C10	0.25
	Short Chain Acyl-CoA dehydrogenase deficiency	SCAD				C4	>= 1.10	C4/C3	>= 0.50
	Trifunctional protein deficiency	TFP				C16OH	>= 0.15	C16OH/C16	>= 0.10
	Very long chain acyl-CoA dehydrogenase deficiency	VLCAD				C14:1	>= 0.60	C14:1/C16	>= 0.20
Organic Acidemias
	Beta-Ketothiolase deficiency	BKT				C5:1	>= 0.20	C5OH	>= 0.80
	Glutaric acidemia type 1	GA 1				C5DC	>= 0.35	C5DC/C16	>= 0.15
	Glutaric Acidemia Type II (aka Multiple acyl-CoA dehydrogenase deficiency)	GA 2				C4	>= 1.10	C5	>= 0.50
	3-Hydroxy 3-methyl glutaric aciduria	HMG				C6DC	>= 0.20	C5OH	>= 0.80
	aciduria
	Isovaleric acidemia	IVA				C5	>= 0.4	C5/C3	>= 0.40
	Malonic Acidemia	MA				C3DC	>= 0.44	C3DC/C10	>= 5.0
	Multiple carboxylase deficiency	MCD				C5OH	>= 1.1	C5OH/C8	>= 11.1
	3-Methylcrotonyl CoA carboxylase deficiency	3MCC
	3 methylglutaconic aciduria	3MGA
	Propionic acidemia	PA				C3	>= 6.05	C3/C2	>= 0.29
	Methylmalonic acidemia (mutase deficiency)	MUT
	Methylmalonic acidemia Cbl A,B	Cbl A,B
Other
	Biotinidase Deficiency	Biot	Biotinidase Deficiency			biotinidase	< 30% normal
							adult
							activity

Cystic Fibrosis	CF	Cystic Fibrosis	CF	Immunoreactive	TWO screens
				Trypsinogen	>= 50 ng/mL
					AND
				DNA	2 Mutations
					1 Mutation + 2 IRTs >= 140
					1 Mutation + 1 IRT >= 140
					1 Mutation + all IRTs < 140
				Immunoreactive	0 Mutations + 2 IRTs >= 140
				Trypsinogen	0 Mutations + 1 IRT >= 140
					0 Mutations + all IRTs < 140

IRT	4% (-002)	Top daily 4%
	Positive (-003)	>=50
	Ultra High (-004)	>=140

Galactosemia GALT Galactosemia GALT Galactose -1-phosphate uridyl transferase <=2.5

GALT GALT Repeat borderline >2.5 to <=3.5 Note: reported as normal on first if in this range

Severe Combine Immunodeficiency	SCID	Severe Combined Immunodeficiency	SCID	TREC
				Inconclusive (birthweight >1500g)	CT 35-37
				Inconclusive (birthweight <1500g)	CT 36-37
				Positive	CT>37

Spinal Muscular Atrophy SMA Spinal Muscular Atrophy SMA SMN1 CT>35 (Really should be undetermined. If not undetermined, evalaute RPP30 and PCR curve.)

X-Linked Adrenoleukodystrophy	X-ALD	X-Linked Adrenoleukodystrophy	X-ALD	C26:0 LPC	> 0.8 Upper 2% for the plate.
					2 samples for a full plate of 80.
					1 partial plate under 50. 2 if over 50 not including repeats.
					Change initial to positive. Run the next day and change confirm to positive.
					After punching completed, open plate in worklist. Create a flag: Free text, Severity: Held
					Result codes for confirm ALD: <=168hr- ALD-C-Con; >168hrs- ALD-C-Pos
					Send for 2nd tier testing.

Congenital Cytomegalvirus	cCMV	Congenital CytomeglaVirus	cCMV	CMV (IE2)
				Positive	Any amplification in either well
				Negative	Undetermined

RPP30
Normal	<=27
Inconclusive	>=27	Repeat sample to try and get at least one well in normal range.

	Endocrine
Endocrine
	Congenital Adrenal Hyperplasia	CAH	Congenital Adrenal Hyperplasia	CAH	17-alpha hydroxy
					progesterone:
					Newborns Weight
					in grams	"Borderline" (1hr-72hr)
					<= 1299	>= 125 ng/mL
					1300-1699	>= 75 ng/mL
					1700- 2199	>= 58 ng/mL
					>= 2200	>= 35 ng/mL
						2nd screens - anything in borderline range called positive

	"Presumptive Positive"
<= 1299	No Presumptive Positive for this weight range
1300-1699	>= 125 ng/mL
1700- 2199	>= 125 ng/mL
>= 2200	>= 125 ng/mL

Endocrine

Congenital Hypothyroidsim	CH	Congenital Hypothyroidism	CH	Thyroid Stimulating	20-39
				Hormone (TSH)	>=40

Thyroxine (T4) < 6

Hemoglobinopathies Hemoglobin

Hemoglobinopathies	HgB	Sickle Cell	FS	Hemoglobin	Any specimen result that does not have any A (adult) is a disease case.
			FSC/FCS
		Disease Cases (no A present)

Bart's (Hemoglobin H) FAB >24% area in FAST region on HPLC; 3 distinct bands in "junk" region on IEF

A is present but variant >2x area of A	FSA	Variants that are >2 times the % area of A indicate other issues in baby
	FUA	Treat like a disease case
	FDA
	FCA
	FEA

Hgb Carriers (FAS, FAD, FAC, FAE, FAU) Any specimen result that is NOT F (fetal) + A (adult) is abnormal

AF Normal AF is Normal if >192 hours, >2000 grams, not transfused

AF Abnormal AF Abnormal if <192 hours old at collection, <2000 grams, transfused

Lysosomal Storage Disorders	LSD or LD
	LSD Seq/Biochem results
	Glycogen Storage Disease Type II	Pompe	GAA	Positive < 6.0 umol/L/hr
				Inconclusive

Mucopolysaccharidosis type I	MPSI	Mucopolysaccharidosis type I	MPSI	IDUA	3.0< Borderline < 4.0 umol/L/hr
					Positive < 4.0 umol/L/hr
					Inconclusive

https://docs.google.com/spreadsheets/u/0/d/1yS86d3JqYBj0t_thKW_YhDYbXiMlVNW-4d0Itm1soaw/edit

File details come from the government source that posted it. Updated Oct 21, 2026.